510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2016

TOTAL 510(k)s THIS PERIOD 213
TOTAL WITH SUMMARIES 205
TOTAL WITH STATEMENTS 8

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2016


DEVICE: O-PEP
PARI RESPIRATORY EQUIPMENT, INC.  510(k) NO: K150044(Traditional)
ATTN: Michael  Judge              PHONE NO : 1 804 2537274 
2412 PARI Way                     SE DECISION MADE: 27-MAY-16
Midlothian VA  23112              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ERBE ESU Model VIO dV with Accessories
ERBE ELEKTROMEDIZIN GMBH          510(k) NO: K150364(Traditional)
ATTN: Axel  Retzlaff              PHONE NO : 49 7071 70755349 
WALDHOERNLESTRASSE, 17            SE DECISION MADE: 05-MAY-16
TUEBINGEN  DE 72072               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Filbloc
ASSUT EUROPE                      510(k) NO: K150553(Traditional)
ATTN: GLORIA  AGGIO               PHONE NO : 39 06 72677348 
ZONA INDUSTRIALE                  SE DECISION MADE: 19-MAY-16
MAGLIANO DEI MARSI  IT 1-67062    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PINPOINT Endoscopic Fluorescence Imaging System
NOVADAQ TECHNOLOGIES, INC.        510(k) NO: K150956(Traditional)
ATTN: TIM  VERSPAGEN              PHONE NO : 604 232 9861 240
13155 DELF PLACE, UNIT 250        SE DECISION MADE: 23-MAY-16
RICHMOND  CA V6V 2A2              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CT/MR Compatible M.A.C. Interstitial GYN Template
Mick Radio-Nuclear Instruments, In510(k) NO: K150979(Traditional)
ATTN: Chuck  Smith                PHONE NO : 914 6673999 
521 Homestead Avenue              SE DECISION MADE: 31-MAY-16
Mount Vermon NY  10550            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venous Assist System
DAESUNG MAREF CO., LTD.           510(k) NO: K150980(Traditional)
ATTN: JAE-WHA  LEE                PHONE NO : 82 31 4597211 
298-24, GONGDAN-RO                SE DECISION MADE: 12-MAY-16
GUNPO-SHI  KR 435-862             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HC Spinal System
HUNG CHUN BIO-S CO., LTD.         510(k) NO: K151362(Traditional)
ATTN: HSIN TAI HU                 PHONE NO : 886 7 6955369 
NO.12, LUKE 1ST RD., LUZHU DIST., SE DECISION MADE: 05-MAY-16
KAOHSIUNG CITY  TW 821            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
MAXTER GLOVE MANUFACTURING SDN BHD510(k) NO: K151390(Traditional)
ATTN: YAP PEAK GEEH               PHONE NO : 60 03 33929888 
LOT 6070, JALAN HAJI ABDUL MANAH, SE DECISION MADE: 02-MAY-16
KLANG  MY 41050                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BTI Dental Implant System UnicCa
B.T.I. BIOTECHNOLOGY INSTITUTE, S.510(k) NO: K151391(Traditional)
ATTN: FERNANDA OLABARRIA ROS      PHONE NO : 34 945 297030 
LEONARDO DA VINCI 14, PARQUE TECNOSE DECISION MADE: 02-MAY-16
MINANO  ES 01510                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kudu
R82 A/S                           510(k) NO: K151492(Traditional)
ATTN: Kent  Rasmussen             PHONE NO : 45 7968 5888 
Parallelvej 3                     SE DECISION MADE: 20-MAY-16
Gedved  DK DK-8751                510(k) STATEMENT
                                                    

DEVICE: MC BIO Supertack Tack 3mm, 4mm and 5mm
ELI-KA TECHNOLOGIES               510(k) NO: K151540(Traditional)
ATTN: LUIGI   GIROTTO             PHONE NO : 626 2563674 
209 MADISON AVE. SUITE-D          SE DECISION MADE: 26-MAY-16
MONROVIA CA  91016                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
IVY BIOMEDICAL SYSTEMS INC.       510(k) NO: K151781(Abbreviated)
ATTN: DICK  LISTRO                PHONE NO : 203 4814183 
11 BUSINESS PARK DRIVE            SE DECISION MADE: 27-MAY-16
BRANFORD CT  06405                510(k) STATEMENT
                                                    

DEVICE: ActTrust
CONDOR INSTRUMENTS LTDA. - EPP    510(k) NO: K151784(Traditional)
ATTN: RODRIGO TREVISAN OKAMOTO    PHONE NO : 55 11 21296662 
AVENIDA BRIGADEIRO LUIS ANTONIO, 5SE DECISION MADE: 25-MAY-16
SAO PAULO  BR 01318-000           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cogent Hemodynamic Monitoring System
ICU MEDICAL INC.                  510(k) NO: K152006(Traditional)
ATTN: Natalie  Hepworth           PHONE NO : 801 2641332 
951 CALLE AMANECER                SE DECISION MADE: 05-MAY-16
SAN CLEMENTE CA  92673            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bindex BI-100
BONE INDEX FINLAND, LTD.          510(k) NO: K152020(Abbreviated)
ATTN: JANNE  KARJALAINEN          PHONE NO : 358 45 8962650 
MICROKATU 1                       SE DECISION MADE: 13-MAY-16
KUOPIO  FI 70211                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
HAMILTON MEDICAL AG               510(k) NO: K152029(Traditional)
ATTN: STEFFEN  BODEN              PHONE NO : 41 58 6101842 
VIA CRUSCH 8                      SE DECISION MADE: 03-MAY-16
BONADUZ  CH 7402                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diagnostic Station DS20
SCHILLER AG                       510(k) NO: K152043(Traditional)
ATTN: ZHENRONG  YU                PHONE NO : 41 41 7664252 
ALTGASSE 68                       SE DECISION MADE: 06-MAY-16
BAAR  CH CH-6341                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIOFOAM Bone Wedge
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K152062(Traditional)
ATTN: VAL   MYLES                 PHONE NO : 901 2905162 
1023 Cherry Road                  SE DECISION MADE: 17-MAY-16
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Astral 100/150
RESMED LTD.                       510(k) NO: K152068(Traditional)
ATTN: Peter  Jennings             PHONE NO : 61 2 88841000 
1 ELIZABETH MACARTHUR DRIVE       SE DECISION MADE: 13-MAY-16
BELLA VISTA   AU 2153             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPS Style Ceram, IPS Style Ceram One, IPS Style Press
Ivoclar Vivadent AG               510(k) NO: K152103(Traditional)
ATTN: Sandra  Cakebread           PHONE NO : 423 235 3535 
Bendererstrasse 2                 SE DECISION MADE: 20-MAY-16
Schaan  LI 9494                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIJOU Orthodontic Ceramic Bracket
WORLD BIO TECH CO., LTD           510(k) NO: K152167(Traditional)
ATTN: JIN-KYU  PARK               PHONE NO : 82 31 7762804 
#302  BIZCENTER, SKNTECHNOPARK, 12SE DECISION MADE: 27-MAY-16
SEONGNAM-SI  KR 462-721           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor
Heidelberg Engineering GmbH       510(k) NO: K152205(Traditional)
ATTN: Gerhard  Zinser             PHONE NO : 49 6221 64630 
                                  SE DECISION MADE: 06-MAY-16
Heidelberg  DE 69121              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Auris Robotic Endoscopy System (ARES)
AURIS SURGICAL ROBOTICS, INC.     510(k) NO: K152319(Traditional)
ATTN: MICHAEL A. DANIEL           PHONE NO : 775 3922970 
125 SHOREWAY ROAD, SUITE D        SE DECISION MADE: 26-MAY-16
SAN CARLOS CA  94070              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEX tanning booth
J & B PRODUCTS LTD DBA HEX TANNING510(k) NO: K152336(Traditional)
ATTN: LINDA  BOMMARITO            PHONE NO : 989 7926119 
2201 S MICHIGAN AVENUE            SE DECISION MADE: 02-MAY-16
SAGINAW MI  48602                 510(k) STATEMENT
                                                    

DEVICE: NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six
North American Rescue, LLC        510(k) NO: K152340(Traditional)
ATTN: William  Slevin             PHONE NO : 864 6759800 
35 Tedwall Court                  SE DECISION MADE: 31-MAY-16
Greer SC  29650                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeraQuest HSV Type 2 Specific IgG
Quest International, Inc.         510(k) NO: K152353(Traditional)
ATTN: David J Kiefer              PHONE NO : 305 9152604 
8127 NW 29th Street               SE DECISION MADE: 13-MAY-16
Miami FL  33122                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Blood Pressure Monitor
SUZHOU SUNSPIRIT CO., LTD.        510(k) NO: K152415(Traditional)
ATTN: Jing  Zhang                 PHONE NO : 86 512 685238996 
No. 72, Hengshan Rd., Suzhou New DSE DECISION MADE: 06-MAY-16
Suzhou  CN 215009                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy
Sunfire Industries Inc.           510(k) NO: K152423(Traditional)
ATTN: Doug  Tyler                 PHONE NO : 800 5524446 
4905 Highway 70 East              SE DECISION MADE: 20-MAY-16
New Bern NC  28562                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Slit Lamp Microscope
SHANGHAI  MEDIWORKS PRECISION INST510(k) NO: K152429(Traditional)
ATTN: WEIDA  ZHAN                 PHONE NO : 0086 21 54260421 
Zone A, 2nd Floor, No. 69, Lane 19SE DECISION MADE: 11-MAY-16
SHANGHAI  CN 200237               510(k) STATEMENT
                                                    

DEVICE: LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating
WALDEMAR LINK GMBH & CO. KG       510(k) NO: K152431(Traditional)
ATTN: HELMUT D. LINK              PHONE NO : 49 40 539950 
BARKHAUSENWEG 10                  SE DECISION MADE: 09-MAY-16
HAMBURG  DE 22339                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vericore Gradient Temporary Disc
WHIP MIX CORPORATION              510(k) NO: K152443(Traditional)
ATTN: JOHN  WATERS                PHONE NO : 502 6345357 
361 FARMINGTON AVENUE             SE DECISION MADE: 11-MAY-16
LOUISVILLE KY  40217              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200
MEDTEK LIGHTING CORP D/B/A PEACOCK510(k) NO: K152452(Traditional)
ATTN: GARY  RICHARDSON            PHONE NO : 518 7473310 
3 DEPOT STREET                    SE DECISION MADE: 19-MAY-16
HUDSON FALLS NY  12839            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORAcollect.Dx
DNA GENOTEK INC.                  510(k) NO: K152464(Traditional)
ATTN: Dan  Fullerton              PHONE NO : 613 7235757 
2 BEAVERBROOK ROAD                SE DECISION MADE: 26-MAY-16
OTTAWA  CA K2K 1L1                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
PROSURG, INC                      510(k) NO: K152466(Traditional)
ATTN: Ashvin  Desai               PHONE NO : 408 9454044 
2193 Trade Zone Blvd              SE DECISION MADE: 19-MAY-16
San Jose CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dr. Wolff Vagisan Moisturising Cream
DR. AUGUST WOLFF GMBH & CO. KG ARZ510(k) NO: K152507(Traditional)
ATTN: THOMAS  FLOETOTTO           PHONE NO : 49 521 8808460 
SUDBRACKSTR. 56                   SE DECISION MADE: 20-MAY-16
BIELEFELD   DE 33611              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UltraCor Twirl Breast Tissue Marker
BARD PERIPHERAL VASCULAR, INC.    510(k) NO: K152510(Traditional)
ATTN: KRISTEN  DEJEU              PHONE NO : 480 3506067 
1625 WEST 3RD STREET              SE DECISION MADE: 13-MAY-16
TEMPE AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Z5 Slit lamp microscope, Z2 Slit lamp microscope
TAKAGI SEIKO CO., LTD.            510(k) NO: K152535(Traditional)
ATTN: Nagaike  Yoshio             PHONE NO : 81 269 224512 
330-2 IWAHUNE, NAKANO-SHI, NAGANO-SE DECISION MADE: 26-MAY-16
NAGANO  JP 383-8585               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Agem Ag Mesh Dressing with Silver
SHENZHEN YUANXING NANO-PHARMA CO.,510(k) NO: K152544(Traditional)
ATTN: LIU  LONGQING               PHONE NO : 0086 755 26740339 
ROOM 1001, RESOURCES-TECH-BUILDINGSE DECISION MADE: 23-MAY-16
SHENZHEN  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oragene Dx
DNA Genotek Inc                   510(k) NO: K152556(Traditional)
ATTN: Dan  Fullerton              PHONE NO : 613 7235757 
2 Beaverbrook Road                SE DECISION MADE: 26-MAY-16
Ottawa  CA k2K 1L1                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TruAbutment Digital Prosthetic Solutions for Osstem GS/TS Interface
TRUABUTMENT                       510(k) NO: K152559(Traditional)
ATTN: BRANDON  KIM                PHONE NO : 714 9561488 
300 SOUTH HARBOR BLVD #520        SE DECISION MADE: 20-MAY-16
ANAHEIM CA  92805                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stivax
BIEGLER GMBH                      510(k) NO: K152571(Traditional)
ATTN: FRIEDRICH  NETAUSCHEK       PHONE NO : 43 197 9210515 
ALLHANGSTRASSE 18A                SE DECISION MADE: 26-MAY-16
MAUERBACH  AT 3001                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KARL STORZ Endoscopic ICG Imaging System
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K152583(Traditional)
ATTN: Mike  Samuels               PHONE NO : 424 2188288 
2151 E. GRAND AVENUE              SE DECISION MADE: 31-MAY-16
EL SEGUNDO CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Green Laser Photocoagulator GYC-500 
NIDEK CO., LTD.                   510(k) NO: K152603(Traditional)
ATTN: YONEJI  MIZUNO              PHONE NO : 81 533 678901 
34-14 MAEHAMA, HIROISHICHO        SE DECISION MADE: 02-MAY-16
GAMAGORI  JP 443-0038             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: eSensor Warfarin Sensitivity Saliva Test  
GENMARK DIAGNOSTICS, INCORPORATED 510(k) NO: K152612(Traditional)
ATTN: ALAN  MADERAZO              PHONE NO : 760 4484308 
5964 LA PLACE COURT               SE DECISION MADE: 26-MAY-16
CARLSBAD CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERIFY STEAM Integrating Indicator
STERIS CORPORATION                510(k) NO: K152630(Traditional)
ATTN: BILL  BRODBECK              PHONE NO : 440 3927690 
5960 HEISLEY ROAD                 SE DECISION MADE: 12-MAY-16
MENTOR OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens
SMART PERFORMER CORP. LTD.        510(k) NO: K152657(Traditional)
ATTN: Jeffersion  Shen            PHONE NO : 886 2 22999699 
No.13-1, WUQUAN 1st RD., XINZHUANGSE DECISION MADE: 17-MAY-16
NEW TAIPEI CITY  TW 242           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak 
BIO-RAD LABORATORIES              510(k) NO: K152679(Traditional)
ATTN: ELIZABETH  PLATT            PHONE NO : 949 5981285 
9500 JERONIMO ROAD                SE DECISION MADE: 10-MAY-16
IRVINE CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TD-1035 Thermometer
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K152680(Traditional)
ATTN: C.W  CHEN                   PHONE NO : 886 266 258188 
6F, NO. 127, WUGONG 2ND RD WUGU DISE DECISION MADE: 06-MAY-16
NEW TAIPEI CITY  TW 24888         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit 
WILLIAN A. COOK AUSTRALIA PTY LTD 510(k) NO: K152682(Special)
ATTN: GORDANA   POZVEK            PHONE NO : 61 7 38411188 
95 BRANDL STREET                  SE DECISION MADE: 05-MAY-16
EIGHT MILE PLAINS  AU 4113        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit
WILLIAM A. COOK AUSTRALIA PTY, LTD510(k) NO: K152717(Special)
ATTN: Gordana  Pozvek             PHONE NO : 61 7 38411188 
95 BRANDL ST                      SE DECISION MADE: 06-MAY-16
EIGHT MILE PLAINS  AU 4113        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReNew Sterilization Trays(Catalog #3708 and #3709)
MICROLINE SURGICAL, INC.          510(k) NO: K152745(Traditional)
ATTN: ANU  GAUR                   PHONE NO : 978 8671726 
50 DUNHAM ROAD, SUITE 1500        SE DECISION MADE: 12-MAY-16
BEVERLY MA  01915                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager
Moor Instruments Ltd              510(k) NO: K152749(Traditional)
ATTN: Stewart  Lillington         PHONE NO : 44 1297 35715 
Millwey Rise                      SE DECISION MADE: 12-MAY-16
Axminster  GB EX13 5HU            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)
BIOMET MANUFACTURING CORP.        510(k) NO: K152754(Traditional)
ATTN: PATRICIA SANDBORN  BERES    PHONE NO : 574 2676639 
56 BELL DRIVE                     SE DECISION MADE: 16-MAY-16
WARSAW IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FREMAP ELECTRODE
AD-TECH MEDICAL INSTRUMENT CORPORA510(k) NO: K152769(Traditional)
ATTN: LISA  THEAMA                PHONE NO : 262 6341555 
1901 WILLIAM STREET               SE DECISION MADE: 06-MAY-16
RACINE WI  53404                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Glocyte Automated Cell Counter System
Advanced Instruments, Inc.        510(k) NO: K152776(Traditional)
ATTN: Robert  Mello               PHONE NO : 781 3209000 2008
2 Technology Way                  SE DECISION MADE: 27-MAY-16
Norwood MD  02062                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FLEX SCORING CATHETER
VENTUREMED GROUP                  510(k) NO: K152789(Traditional)
ATTN: TIFFINI  DIAGE              PHONE NO : 707 7996732 
5855 MONROE ST SUITE 220 A        SE DECISION MADE: 25-MAY-16
SYLVANIA OH  43560                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves
Ideal Plastic Co., Ltd.           510(k) NO: K152818(Traditional)
ATTN: Lily  Li                    PHONE NO : 86 311 67699828 
#58, Heping West Rd.              SE DECISION MADE: 26-MAY-16
Shijiazhuang  CN 050000           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Catalyst CSR Shoulder System
CATALYST ORTHOSCIENCE LLC         510(k) NO: K152825(Traditional)
ATTN: STEPHEN  HERRINGTON         PHONE NO : 1 800 5875137 
5867 WHISPERWOOD CT               SE DECISION MADE: 11-MAY-16
NAPLES FL  34110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NoCord
CENTRIX, INC.                     510(k) NO: K152826(Traditional)
ATTN: GREG  MOREAU                PHONE NO : 203 5677444 
770 RIVER ROAD                    SE DECISION MADE: 27-MAY-16
SHELTON CT  06484                 510(k) STATEMENT
                                                    

DEVICE: WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT  ENDOPROSTHESIS TRACHEOBRONCHIAL
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K152842(Traditional)
ATTN: CARAH  KUCHARSKI            PHONE NO : 763 2550738 
ONE SCIMED PLACE                  SE DECISION MADE: 19-MAY-16
MAPLE GROVE MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UCP COMPACT DRUG TESTS
UCP BIOSCIENCES, INC              510(k) NO: K152908(Traditional)
ATTN: NANCY  CHEN                 PHONE NO : 408 3920064 
1445 KOLL CIRCLE SUITE 111        SE DECISION MADE: 03-MAY-16
SAN JOSE CA  95112                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EarlySense Insight Sytem
EarlySense Ltd.                   510(k) NO: K152911(Traditional)
ATTN: Dalia  Argaman              PHONE NO : 972 3 7522330 106
12 Tzvi Street                    SE DECISION MADE: 06-MAY-16
Ramat Gan  IL 5250429             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PeriFlux6000
PERIMED AB                        510(k) NO: K152930(Traditional)
ATTN: MARIA PRANS LILJEVRET       PHONE NO : 46 8 58011990 
DATAVAGEN 9A                      SE DECISION MADE: 05-MAY-16
JARFALLA  SE 17543                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulp Canal Sealer, Pulp Canal Sealer EWT
SYBRON DENTAL SPECIALTIES         510(k) NO: K152956(Traditional)
ATTN: COURTNEY  CLARK             PHONE NO : 714 5167426 
1717 W. COLLINS AVE.              SE DECISION MADE: 06-MAY-16
ORANGE CA  92867                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INVISION Total Ankle Revision System
Wright Medical Technology, Inc.   510(k) NO: K153008(Traditional)
ATTN: Tara  Conrad                PHONE NO : 901 8674367 
1023 Cherry Road                  SE DECISION MADE: 06-MAY-16
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement
MEDTEC, INC. D/B/A CIVCO MEDICAL S510(k) NO: K153026(Traditional)
ATTN: AMANDA  STAHLE              PHONE NO : 319 2486628 
1401 8TH STREET SE                SE DECISION MADE: 25-MAY-16
ORANGE CITY IA  51041             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator
EASYMED INSTRUMENT CO., LTD.      510(k) NO: K153045(Special)
ATTN: Jeffery  Wu (Tingjie Wu)    PHONE NO : 86 757 28091300 
5/F-6/F, BLK A, GUPO GONGMAO BLD FSE DECISION MADE: 13-MAY-16
DALIANG, SHUNDE, FOSHAN  CN 528300510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INCLUSIVE TAPERED IMPLANT SYSTEM
PRISMATIK DENTALCRAFT, INC.       510(k) NO: K153099(Traditional)
ATTN: ARMIN  ZEHTABCHI            PHONE NO : 949 2251234 
2212 DUPONT DRIVE SUITE P         SE DECISION MADE: 23-MAY-16
IRVINE CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System
CHOICE SPINE, LP                  510(k) NO: K153107(Special)
ATTN: KIM  FINCH                  PHONE NO : 865 2463333 
400 Erin Drive                    SE DECISION MADE: 19-MAY-16
KNOXVILLE TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TOUAREG CloseFit™ UNP 2.75mmD
Adin Dental Implants Systems Ltd. 510(k) NO: K153111(Traditional)
ATTN: Ilana  Lutvak               PHONE NO : 972 4 6426732 
Alon Tavor Industrial Zone, P.O. BSE DECISION MADE: 06-MAY-16
Afula  IL 1811101                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: everX Posterior
GC AMERICA INC.                   510(k) NO: K153127(Traditional)
ATTN: MARK  HEISS                 PHONE NO : 708 9263092 
3737 W. 127TH STREET              SE DECISION MADE: 20-MAY-16
ALSIP IL  60803                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Achieve ST Mapping Catheter, Catheter Connecting Cable
MEDTRONIC, INC.                   510(k) NO: K153139(Traditional)
ATTN: Heath  Taylor               PHONE NO : 763 5269066 
8200 CORAL SEA STREET NE Mail StopSE DECISION MADE: 06-MAY-16
MOUNDS VIEW MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36
SEJOY ELECTRONICS & INSTRUMENTS CO510(k) NO: K153149(Traditional)
ATTN: Ren  Yunhua                 PHONE NO : 86 571 81957767 
Building 2, No. 202, Zhenzhong RoaSE DECISION MADE: 27-MAY-16
Hangzhou  CN 310030               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hypocore
NOVOCOR MEDICAL SYSTEMS, INC      510(k) NO: K153162(Traditional)
ATTN: TAMMY  CARREA               PHONE NO : 919 5260989 
2 DAVIS DRIVE                     SE DECISION MADE: 24-MAY-16
DURHAM NC  27709                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay
C.R. BARD, INC.                   510(k) NO: K153236(Traditional)
ATTN: SHWETA   CONNER             PHONE NO : 401 8258464 
100 CROSSINGS BOULEVARD           SE DECISION MADE: 13-MAY-16
WARWICK RI  02886                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LSFG-NAVI
Softcare Co., Ltd                 510(k) NO: K153239(Traditional)
ATTN: Noriyoshi  Takahashi        PHONE NO : 81 940 369693 
243-5 Yatsunami                   SE DECISION MADE: 12-MAY-16
Fukutsu  JP 811-3201              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EasyPass Guidewire
MEDI-GLOBE CORPORATION            510(k) NO: K153264(Traditional)
ATTN: SCOTT  KARLER               PHONE NO : 480 8972772 208
7850 SOUTH HARDY DRIVE STE. 112   SE DECISION MADE: 19-MAY-16
TEMPE AZ  85284                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 6200 Ultrasound System and 6250 Ultrasound System
Esaote S.p.A.                     510(k) NO: K153277(Traditional)
ATTN: Donatella  Ragghianti       PHONE NO : 011 39 0106547259 
Via Siffredi 58                   SE DECISION MADE: 04-MAY-16
Genovo  IT 16153                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)
Cardinal Health, Inc.             510(k) NO: K153316(Traditional)
ATTN: Megan  Middaugh             PHONE NO : 847 8876812 
1500 Waukegan Road                SE DECISION MADE: 12-MAY-16
Waukegan IL  60085                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SafeCT-29
MEDIC VISION IMAGING SOLUTIONS    510(k) NO: K153331(Traditional)
ATTN: EYAL  AHARON                PHONE NO : 972 737 262226 
3 YOZMA                           SE DECISION MADE: 17-MAY-16
TIRAT CARMEL  IL 3903203          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oral-B 5% Sodium Fluoride Varnish
YOUNG DENTAL MANUFACTURING CO 1, L510(k) NO: K153334(Traditional)
ATTN: Sarah  Moore                PHONE NO : 314 3728040 
13705 SHORELINE CT. EAST          SE DECISION MADE: 20-MAY-16
EARTH CITY MO  63045              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Orthopaedics Hip Systems Labeling Update
STRYKER ORTHOPAEDICS              510(k) NO: K153345(Traditional)
ATTN: MARGARET  KLIPPEL           PHONE NO : 201 8315559 
325 Corporate Drive               SE DECISION MADE: 25-MAY-16
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IBS Implant System
INNOBIOSURG CO., LTD              510(k) NO: K153350(Traditional)
ATTN: Bo-reum   Yoo               PHONE NO : 82 42 9332879 
44-19, Techno 10-ro, Yuseong-gu   SE DECISION MADE: 09-MAY-16
Daejeon   KR 305-510              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Standard Clamp
STANDARD BARIATRICS               510(k) NO: K153358(Traditional)
ATTN: ALISON  SATHE               PHONE NO : 513 3047971 
4362 GLENDALE MILFORD RD.         SE DECISION MADE: 02-MAY-16
CINCINNATI OH  45242              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BardPort®, SlimPort®, and X-Port® Implanted Ports
C.R. BARD, INC.                   510(k) NO: K153359(Special)
ATTN: JAMES R. DAVIS              PHONE NO : 801 5225456 
605 NORTH 5600 WEST               SE DECISION MADE: 20-MAY-16
SALT LAKE CITY UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AxSOS 3Ti
Stryker GmbH                      510(k) NO: K153379(Traditional)
ATTN: Saad  Attiyah               PHONE NO : 201 8315655 
Bohnackerweg 1                    SE DECISION MADE: 26-MAY-16
2545 Selzach  CH CH 2545          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aesculap OrthoPilot Next Generation
AESCULAP IMPLANT SYSTEMS, LLC     510(k) NO: K153396(Traditional)
ATTN: Paul  Amudala               PHONE NO : 1 800 2349179 
3773 Corporate Parkway            SE DECISION MADE: 16-MAY-16
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMMa Electronic Monitoring Management
VITASYSTEMS GMBH                  510(k) NO: K153477(Traditional)
ATTN: Michael  Rothhaar           PHONE NO : 49 621 178918174 
MARKIRCHER STR. 22                SE DECISION MADE: 25-MAY-16
Mannheim  DE 68229                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DD medical polymers
DENTAL DIREKT GMBH                510(k) NO: K153490(Traditional)
ATTN: UWE  GREITENS               PHONE NO : 49 522 5863190 
INDUSTRIEZENTRUM 106-108          SE DECISION MADE: 13-MAY-16
SPENGE  DE 32139                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit
CONSURE MEDICAL PVT LTD.          510(k) NO: K153506(Traditional)
ATTN: Nishith  Chasmawala         PHONE NO : 91 991 0028379 
5L, THIRD FLOOR, SHAHPUR JAT      SE DECISION MADE: 06-MAY-16
New Delhi  IN 110049              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Pulse Stimulator
JKH HEALTH CO.,LTD.               510(k) NO: K153520(Traditional)
ATTN: Pu   Jiang                  PHONE NO : 86 755 27926589 
4-5F, Building 12, Hengmingzhu IndSE DECISION MADE: 05-MAY-16
Shenzhen  CN 518104               510(k) STATEMENT
                                                    

DEVICE: SiO2 Coated syringe 3 ml
SiO2 Medical Products             510(k) NO: K153553(Traditional)
ATTN: Sandra  L  True             PHONE NO : 334 3215036 
350 Enterprise Drive              SE DECISION MADE: 17-MAY-16
Auburn AL  36830                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AirFit F20
RESMED LTD.                       510(k) NO: K153563(Traditional)
ATTN: Johanna  Wright             PHONE NO : 
1 ELIZABETH MACARTHUR DRIVE       SE DECISION MADE: 13-MAY-16
BELLA VISTA   AU 2153             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prometheus ChitoGauze XR PRO
HEMCON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K153582(Traditional)
ATTN: Maire   Ni Beilliu          PHONE NO : 971 3275729 
720 SW WASHINGTON STREET, SUITE 20SE DECISION MADE: 25-MAY-16
PORTLAND OR  97205                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flip Button Suture Anchor
FIRST RAY LLC                     510(k) NO: K153585(Traditional)
ATTN: Robert   Hoy                PHONE NO : 614 4486358 
124 SOUTH 600 WEST, SUITE 100     SE DECISION MADE: 05-MAY-16
LOGAN  UT  84321                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
HEALGEN SCIENTIFIC LLC            510(k) NO: K153597(Special)
ATTN: Jianqiu  Fang               PHONE NO : 713 7338088 
5213 MAPLE ST                     SE DECISION MADE: 23-MAY-16
BELLAIRE TX  77401                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeoFuse HA Enhanced PLIF/TLIF
HT MEDICAL, LLC                   510(k) NO: K153615(Traditional)
ATTN: ROBERT  COMPTON             PHONE NO : 417 3099457 
6316 E. 102ND STREET              SE DECISION MADE: 06-MAY-16
TULSA OK  74137                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Enovare Ultrasound System
OREON TECHNOLOGIES INC.           510(k) NO: K153620(Traditional)
ATTN: Howard   Fidel              PHONE NO : 914 4130087 
520 WHITE PLAINS RD               SE DECISION MADE: 05-MAY-16
HARRYTOWN NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ArcadiusXP C Spinal System
Aesculap Implant Systems, Inc.    510(k) NO: K153629(Traditional)
ATTN: Lisa M Boyle                PHONE NO : 610 9849274 
3773 Corporate Parkway            SE DECISION MADE: 25-MAY-16
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microdent Ektos Implant System
IMPLANTS MICRODENT SYSTEM S.L     510(k) NO: K153650(Traditional)
ATTN: JORDI CLAPES DONADEU        PHONE NO : 34 93 8447663 
C/ CARLES BUIGAS, I-CAN MAGRE     SE DECISION MADE: 20-MAY-16
SANTA EULALIA DE RONCANA  ES 08187510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vanguard XP Knee System
BIOMET, INC.                      510(k) NO: K153657(Traditional)
ATTN: JULIE  GANTENBERG           PHONE NO : 574 3778133 
56 EAST BELL DRIVE                SE DECISION MADE: 10-MAY-16
WARSAW IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Target Detachable Coils
Stryker Neurovascular             510(k) NO: K153658(Traditional)
ATTN: Kate  Taylor                PHONE NO : 510 4132175 
47900 Bayside Parkway             SE DECISION MADE: 19-MAY-16
Fremont CA  94538-2588            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vario 8/18/ci
MEDELA AG                         510(k) NO: K153663(Traditional)
ATTN: MARKUS  BUTLER              PHONE NO : 41 041 5616671 
LATTICHSTRASSE 4B                 SE DECISION MADE: 18-MAY-16
BAAR  CH 6341                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Genteel Lancing Device
Genteel, LLC                      510(k) NO: K153670(Traditional)
ATTN: Christopher  Jacobs         PHONE NO : 844 4368335 
4011 Livingstone St.              SE DECISION MADE: 12-MAY-16
Midland TX  79707                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AirFit N20
ResMed Ltd                        510(k) NO: K153673(Traditional)
ATTN: Kim Kuan Lee                PHONE NO : 61 2 88841000 
1 Elizabeth Macarthur Drive       SE DECISION MADE: 02-MAY-16
Bella Vista  AU 2153              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trak Male Fertility Testing System
SANDSTONE DIAGNOSTICS, INC.       510(k) NO: K153683(Traditional)
ATTN: Greg   Sommer               PHONE NO : 925 3157246 
6111 SOUTHFRONT ROAD, SUITE J     SE DECISION MADE: 16-MAY-16
LIVERMORE CA  94551               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guiding Catheter
Texas Medical Technologies, Inc.  510(k) NO: K153703(Traditional)
ATTN: Aaron  Chiu                 PHONE NO : 915 7744321 
9005 Montana Ave., Suite A        SE DECISION MADE: 12-MAY-16
El Paso TN  79925                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
GPC MEDICAL LTD                   510(k) NO: K153716(Traditional)
ATTN: VIKAS  NARANG               PHONE NO : 91 11 4222600 
M-BLOCK, DDA LSC, VIKAS PURI,     SE DECISION MADE: 17-MAY-16
 NEW DELHI  IN 110018             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENZA Zero-Profile Anterior Interbody Fusion
Camber Spine Technologies         510(k) NO: K153720(Traditional)
ATTN: Michael  Black              PHONE NO : 855 8999869 
418 E. Lancaster Ave.             SE DECISION MADE: 03-MAY-16
Wayne PA  19087                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3mensio Workstation
Pie Medical Imaging B.V.          510(k) NO: K153736(Traditional)
ATTN: Annemiek  Bouts             PHONE NO : 31 43 3281328 
Philipsweg 1                      SE DECISION MADE: 27-MAY-16
Maastricht  NL 6227 AJ            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PIEZOSURGERY PLUS
MECTRON SPA                       510(k) NO: K153743(Traditional)
ATTN: ZUNINO  FRANCO              PHONE NO : 39 0185 35361 
VIA LORETO 15                     SE DECISION MADE: 25-MAY-16
CORASCO  IT 16042                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider
SURGICAL INSTRUMENT SERVICE AND SA510(k) NO: K153745(Traditional)
ATTN: BRANDI J. PANTELEON         PHONE NO : 541 9233310 
2747 SW 6TH ST.                   SE DECISION MADE: 02-MAY-16
REDMOND OR  97756                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smartdop XT6
KOVEN TECHNOLOGY, INC.            510(k) NO: K153762(Traditional)
ATTN: Heather  Bell               PHONE NO : 314 5422101 
12125 WOODCREST EXECUTIVE DR SUITESE DECISION MADE: 25-MAY-16
ST LOUIS MO  63141                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nester Embolization Coils, Tornado Embolization Coils
COOK INCORPORATED                 510(k) NO: K153778(Traditional)
ATTN: David  Lehr                 PHONE NO : 812 3353575 102309
750 DANIELS WAY                   SE DECISION MADE: 19-MAY-16
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF
SpineVision S.A.                  510(k) NO: K153783(Traditional)
ATTN: Helene  PLAS                PHONE NO : 33 0153 332525 
10 rue de la Renaissance, Batment SE DECISION MADE: 04-MAY-16
Antony  FR 92160                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit
Irvine Scientific                 510(k) NO: K160006(Traditional)
ATTN: Jayme  Yamaguchi-Owens      PHONE NO : 800 4375706 254
2511 Daimler St                   SE DECISION MADE: 04-MAY-16
Santa Ana CA  92705               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SERFAS 90-S Electrosurgical Probe
STRYKER CORPORATION               510(k) NO: K160050(Traditional)
ATTN: SOMI  EKWEALOR              PHONE NO : 408 7542356 
5900 Optical Court                SE DECISION MADE: 03-MAY-16
SAN JOSE CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CUR Model 1
Thimble Bioelectronics, Inc.      510(k) NO: K160052(Traditional)
ATTN: Shaun  Rahimi               PHONE NO : 408 7998783 
2011 26th St. Ste. 202            SE DECISION MADE: 20-MAY-16
San Francisco CA  94107           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Monopolar single-use HF cable
Olympus Winter & Ibe GmbH         510(k) NO: K160053(Traditional)
ATTN: Katharina  Campbell         PHONE NO : 49 40 669662997 
Kuehnstr. 61                      SE DECISION MADE: 06-MAY-16
Hamburg  DE 22045                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ArcCHECK-MR
Sun Nuclear Corporation           510(k) NO: K160057(Traditional)
ATTN: James  Luker                PHONE NO : 321 2596862 2428
3275 Suntree Blvd.                SE DECISION MADE: 13-MAY-16
Melbourne FL  32940               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System
GEMSS MEDICAL SYSTEMS CO., LTD    510(k) NO: K160065(Traditional)
ATTN: Sang Woo Lee                PHONE NO : 82 31 7647321 
2nd Floor, 29, Dunchon-daero 541 bSE DECISION MADE: 20-MAY-16
Seongnam-si  KR 13216             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Swan Ganz Catheters
Edwards Lifesciences, LLC         510(k) NO: K160084(Traditional)
ATTN: Mugdha  Dongre              PHONE NO : 949 2504602 
One Edwards Way                   SE DECISION MADE: 03-MAY-16
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumipulse G ROMA
Fujirebio Diagnostics, Inc.       510(k) NO: K160090(Traditional)
ATTN: Diana  Dickson              PHONE NO : 610 2403917 
201 Great Valley Parkway          SE DECISION MADE: 16-MAY-16
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Temperature Probe, Affinity Temperature Probe
Medtronic, Inc.                   510(k) NO: K160091(Traditional)
ATTN: Choua  Thao                 PHONE NO : 763 5149842 
7611 Northland Dr.                SE DECISION MADE: 20-MAY-16
Brooklyn Park MN  55428           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STROPP (Single Tunnel Repair of Plantar Plate)
CROSSROADS EXTREMITY SYSTEMS, LLC 510(k) NO: K160118(Traditional)
ATTN: Vernon   Hartdegen          PHONE NO : 901 2218406 
6055 PRIMACY PKWY SUITE 140       SE DECISION MADE: 03-MAY-16
MEMPHIS TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trillium Oval V 5.1 MRI System
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K160152(Traditional)
ATTN: Douglas  Thistlethwaite     PHONE NO : 330 4251313 
1959 SUMMIT COMMERCE PARK         SE DECISION MADE: 20-MAY-16
TWINSBURG OH  44087               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALTA Anterior Cervical Interbody Spacer
Astura Medical                    510(k) NO: K160154(Traditional)
ATTN: Troy  Taylor                PHONE NO : 760 8148047 
5670 El Camino Real, Suite B      SE DECISION MADE: 13-MAY-16
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Haemonetics Cell Saver Elite Autotransfusion System
Haemonetics Corporation           510(k) NO: K160197(Traditional)
ATTN: Mark  Anzalone              PHONE NO : 781 3569912 
400 WOOD ROAD                     SE DECISION MADE: 24-MAY-16
BRAINTREE MA  02184               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector
Implanet, S.A.                    510(k) NO: K160226(Traditional)
ATTN: Regis  Le Couedic           PHONE NO : 33 557 995555 
Technopole Bordeaux Montesquieu, ASE DECISION MADE: 18-MAY-16
Martillac  FR 33650               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Perimeter Otis™ 1.0 Optical Coherence Tomography System
PERIMETER MEDICAL IMAGING, INC.   510(k) NO: K160240(Traditional)
ATTN: ELIZABETH   MUNRO           PHONE NO : 844 4929793 
156 FRONT STREET WEST, SUITE 501  SE DECISION MADE: 13-MAY-16
TORONTO  CA M5J 2L6               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Livewire Steerable Diagnostic EP Catheter
INNOVATIVE HEALTH, LLC            510(k) NO: K160242(Traditional)
ATTN: RAFAL  CHUDZIK              PHONE NO : 480 5256006 
1435 NORTH HAYDEN ROAD, SUITE 100 SE DECISION MADE: 10-MAY-16
SCOTTSDALE AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GORE DrySeal Flex Introducer Sheath
W.L. GORE & ASSOCIATES, INC.      510(k) NO: K160254(Traditional)
ATTN: Mary   Townsend             PHONE NO : 928 8644192 
1505 N FOURTH STREET              SE DECISION MADE: 12-MAY-16
Flagstaff AZ  86004               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MagPro R20
TONICA ELEKTRONIK A/S             510(k) NO: K160280(Traditional)
ATTN: Lise   Terkelsen            PHONE NO : 45 449 98444 
LUCERNEMARKEN 15                  SE DECISION MADE: 16-MAY-16
Farum  DK 3520                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MasterLoc Stem
MEDACTA INTERNATIONAL             510(k) NO: K160289(Traditional)
ATTN: MICHAEL  G. LOITERMAN       PHONE NO : 41 91 6966060 
STRADA REGINA                     SE DECISION MADE: 20-MAY-16
CASTEL SAN PIETRO  CH CH 6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Valleylab REM Polyhesive Infant Patient Return Electrode
Covidien LLC                      510(k) NO: K160290(Traditional)
ATTN: Nancy   Sauer               PHONE NO : 303 5816791 
5920 LONGBOW DRIVE                SE DECISION MADE: 19-MAY-16
BOULDER CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Polaris X Steerable Diagnostic EP Catheter
Innovative Health, LLC.           510(k) NO: K160303(Traditional)
ATTN: Rafal  Chudzik              PHONE NO : 480 5256006 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 10-MAY-16
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: neoBLUE® LED Phototherapy System
Natus Medical Incorporated        510(k) NO: K160305(Traditional)
ATTN: Judy  Buckham               PHONE NO : 800 4260353 5187
5900 First Avenue South           SE DECISION MADE: 27-MAY-16
Seattle WA  98108                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FiberTak DR
ARTHREX, INC.                     510(k) NO: K160319(Special)
ATTN: IVETTE  GALMEZ              PHONE NO : 239 6435553 17263
1370 CREEKSIDE BOULEVARD          SE DECISION MADE: 10-MAY-16
NAPLES FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cervical Interbody Fusion System
EVOLUTION SPINE, LLC              510(k) NO: K160324(Traditional)
ATTN: ASHTON  KOUZBARI            PHONE NO : 214 6828536 
4225 OFFICE PARKWAY               SE DECISION MADE: 05-MAY-16
DALLAS TX  75204                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker SDC3 HD Information Management System with Wireless Device Control Capability
Stryker Endoscopy                 510(k) NO: K160332(Traditional)
ATTN: Angela   Wong               PHONE NO : 408 7542000 
5900 Optical Court                SE DECISION MADE: 18-MAY-16
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMPOWR PS Knee System
Encore Medical, L.P.              510(k) NO: K160342(Traditional)
ATTN: Teffany  Hutto              PHONE NO : 512 8346255 
9800 Metric Blvd.                 SE DECISION MADE: 19-MAY-16
Austin TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016
Visco Vision Inc                  510(k) NO: K160344(Traditional)
ATTN: Evan  Huang                 PHONE NO : 886 3 3596868 
No. 1, Xingye St., Guishan Dist., SE DECISION MADE: 26-MAY-16
Taoyuan  TW 33341                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MX50T(MX50TQS)
WIDE CORPORATION                  510(k) NO: K160354(Traditional)
ATTN: YeoJin   Yun                PHONE NO : 82 31 2181675 
12 WONGOMAE-RO, GIHEUNG-GU        SE DECISION MADE: 02-MAY-16
YONGIN-SI  KR 17086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Third Eye Panoramic Auxiliary Endoscopy System - Resposable
AVANTIS MEDICAL SYSTEMS, INC.     510(k) NO: K160356(Traditional)
ATTN: Louis   Fries               PHONE NO : 408 7331901 
2367 BERING DRIVE                 SE DECISION MADE: 17-MAY-16
San Jose CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRINITY
KOELIS                            510(k) NO: K160357(Traditional)
ATTN: LAETITIA  GERVAIS           PHONE NO : 33 476 637587 
5 Avenue du Grand Sablon          SE DECISION MADE: 02-MAY-16
La Tronche  FR 38700              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LT-300 HD
Lutech Industries, Inc.           510(k) NO: K160380(Traditional)
ATTN: Ronald  Vachula             PHONE NO : 631 5846688 
105 Remington Blvd., Suite C      SE DECISION MADE: 13-MAY-16
Ronkonkoma NY  11779              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AdTec
AESCULAP, INC.                    510(k) NO: K160393(Special)
ATTN: Jessica  Stigliano          PHONE NO : 610 9849063 
3773 CORPORATE PARKWAY            SE DECISION MADE: 26-MAY-16
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartStart Air/Water and Suction Valves
ENDOCHOICE, INC.                  510(k) NO: K160403(Traditional)
ATTN: DANIEL  HOEFER              PHONE NO : 678 7084743 
11810 WILLS ROAD                  SE DECISION MADE: 19-MAY-16
ALPHARETTA GA  30009              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes
MAUNA KEA TECHNOLOGIES            510(k) NO: K160416(Special)
ATTN: VERONIQUE  DENTAN           PHONE NO : 33 170 080994 
9, RUE D'ENGHIEN                  SE DECISION MADE: 20-MAY-16
PARIS  FR 75010                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Monoject Enteral Feeding Syringe with ENFit Connector
COVIDIEN                          510(k) NO: K160419(Traditional)
ATTN: Sona  Manickam              PHONE NO : 508 2618147 
15 HAMPSHIRE STREET               SE DECISION MADE: 12-MAY-16
MANSFIELD MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Certex Spinal Fixation System
X-spine Systems, Inc.             510(k) NO: K160428(Traditional)
ATTN: David  Kirschman            PHONE NO : 937 8478400 
452 Alexandersville Rd.           SE DECISION MADE: 05-MAY-16
Miamisburg OH  45342              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Penumbra System, Penumbra Pump MAX
PENUMBRA, INC.                    510(k) NO: K160449(Traditional)
ATTN: RICHARD  KIMURA             PHONE NO : 510 9952034 
ONE PENUMBRA PLACE                SE DECISION MADE: 25-MAY-16
ALAMEDA CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reliance Lumbar IBF System
Reliance Medical Systems, LLC     510(k) NO: K160463(Special)
ATTN: Bret  M Berry               PHONE NO : 801 2953280 
545 West 500 South, Suite 100     SE DECISION MADE: 20-MAY-16
Bountiful UT  84010               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PicoSure Workstation
Cynosure, Inc                     510(k) NO: K160480(Traditional)
ATTN: Amy  Tannenbaum             PHONE NO : 781 9932454 
5 Carlisle Road                   SE DECISION MADE: 17-MAY-16
Westford MA  01886                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Noxilizer Surgical Ruler
Noxilizer,Inc.                    510(k) NO: K160501(Traditional)
ATTN: Mary   Dadone               PHONE NO : 443 8424402 
800 West Baltimore Street Suite 15SE DECISION MADE: 26-MAY-16
Baltimore MD  21201               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vented Vial Adapter Transfer Device - 13mm
MEDIMOP MEDICAL PROJECTS LTD.     510(k) NO: K160503(Special)
ATTN: Ilanit   Goldgraber         PHONE NO : 972 9 7778666 
17 HATIDHAR ST.                   SE DECISION MADE: 04-MAY-16
RA'ANANA  IL 4366519              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Planmeca ProMax 3D Max, Planmeca Maximity
PLANMECA OY                       510(k) NO: K160506(Traditional)
ATTN: LARS  MORING                PHONE NO : 358 20 7795500 
ASENTAJANKATU 6                   SE DECISION MADE: 20-MAY-16
HELSINKI  FI 00880                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)
PENUMBRA, INC.                    510(k) NO: K160533(Traditional)
ATTN: RICHARD  KIMURA             PHONE NO : 510 9952034 
ONE PENUMBRA PLACE                SE DECISION MADE: 24-MAY-16
ALAMEDA CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navio
Blue Belt Technologies, Inc.      510(k) NO: K160537(Traditional)
ATTN: Richard G. Confer           PHONE NO : 763 4524950 
2905 Northwest Blvd. Ste 40       SE DECISION MADE: 19-MAY-16
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Precision Spine Interspinous Plate System
Precision Spine, Inc.             510(k) NO: K160568(Traditional)
ATTN: Michael C. Dawson           PHONE NO : 601 4204244 128
2050 Executive Drive              SE DECISION MADE: 04-MAY-16
Pearl  MS  39280                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Creatine Kinase
Roche Diagnostics Operations (RDO)510(k) NO: K160570(Traditional)
ATTN: Noel B. Mencias             PHONE NO : 317 5213172 
9115 Hague Road                   SE DECISION MADE: 25-MAY-16
Indianapolis MD  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric
Alcon Laboratories, Inc.          510(k) NO: K160609(Traditional)
ATTN: Alicia M. Plesnarski        PHONE NO : 678 4153924 
6201 South Freeway                SE DECISION MADE: 02-MAY-16
Fort Worth TX  76134-2099         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture         
M/S. MERIL ENDO SURGERY PRIVATE LI510(k) NO: K160623(Traditional)
ATTN: Umesh   Sharma              PHONE NO : 91 0260 3052100 
3FL, E1-E3, MERIL PARK, SURVEY NO.SE DECISION MADE: 31-MAY-16
Chala, Vapi  IN 396191            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electrosurgical Generator ESG-200
OLYMPUS WINTER & IBE GMBH         510(k) NO: K160639(Traditional)
ATTN: Katharina   Campbell        PHONE NO : 49 40 669662997 
KUEHNSTR. 61                      SE DECISION MADE: 04-MAY-16
Hamburg  DE 22045                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4
Siemens Healthcare Diagnostics Inc510(k) NO: K160647(Traditional)
ATTN: Matthew  Gee                PHONE NO : 914 5242099 
511 Benedict Avenue               SE DECISION MADE: 31-MAY-16
Tarrytown NY  10591-5097          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)
Covidien LLC                      510(k) NO: K160654(Special)
ATTN: Rebecca   Magnanimo         PHONE NO : 203 4926479 
60 MIDDLETOWN AVE                 SE DECISION MADE: 04-MAY-16
North Haven CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oasis Lacrimal Intubation Set
ANODYNE                           510(k) NO: K160710(Traditional)
ATTN: VALERIE  ANDERSON           PHONE NO : 636 4471010 
804 CORPORATE CENTRE DRIVE        SE DECISION MADE: 13-MAY-16
O' FALLON MO  63368               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stealth-Midas System
MEDTRONIC POWERED SURGICAL SOLUTIO510(k) NO: K160713(Traditional)
ATTN: DEEP  PAL                   PHONE NO : 817 7886400 
4620 NORTH BEACH ST.              SE DECISION MADE: 26-MAY-16
FORT WORTH TX  76137              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoFLIP
CROSPON LTD.                      510(k) NO: K160725(Traditional)
ATTN: JOHN  O'DEA                 PHONE NO : 011 353 91519882 
GALWAY BUSINESS PARK, DANGAN      SE DECISION MADE: 01-MAY-16
GALWAY  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology
SURGICAL INSTRUMENT SERVICE AND SA510(k) NO: K160740(Traditional)
ATTN: BRANDI  J. PANTELEON        PHONE NO : 541 9233310 
2747 SW 6TH ST.                   SE DECISION MADE: 06-MAY-16
REDMOND OR  97756                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Yarlap II
INTERNATIONAL TRADE GROUP, INC.   510(k) NO: K160773(Traditional)
ATTN: BRENT C. REIDER             PHONE NO : 614 5687000 
4663 KATIE LANE                   SE DECISION MADE: 04-MAY-16
OXFORD OH  45056                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reveal LINQ
MEDTRONIC, INC.                   510(k) NO: K160809(Special)
ATTN: Dianna  L  Johannson        PHONE NO : 763 5262376 
8200 CORAL SEA ST NW              SE DECISION MADE: 26-MAY-16
MOUNDS VIEW MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ViZion DR + Wireless
Viztek LLC                        510(k) NO: K160810(Traditional)
ATTN: Bruce  Ashby                PHONE NO : 800 3665343 
2217 US HWY 70 East               SE DECISION MADE: 20-MAY-16
Garner NC  27529                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K160845(Special)
ATTN: Yingying  Gao               PHONE NO : 508 6834356 
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 03-MAY-16
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: United Urologics Closed System Catheter
ROBLING MEDICAL, INC.             510(k) NO: K160877(Traditional)
ATTN: Diane   Peper               PHONE NO : 919 5709605 
90 Weathers Street                SE DECISION MADE: 20-MAY-16
Youngsville NC  27596             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIB Stent Placement Catheter
NUMED, INC.                       510(k) NO: K160889(Traditional)
ATTN: NICHELLE  LAFLESH           PHONE NO : 315 3284491 
2880 MAIN ST.                     SE DECISION MADE: 20-MAY-16
HOPKINTON NY  12965               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners
C.R. BARD INC.                    510(k) NO: K160900(Traditional)
ATTN: Andrew   Harrell            PHONE NO : 410 8258472 
100 CROSSINGS BLVD                SE DECISION MADE: 31-MAY-16
Warwick RI  02886                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mariner Pedicle Screw System
SEASPINE ORTHOPEDICS CORPORATION  510(k) NO: K160902(Traditional)
ATTN: GINA  FLORES                PHONE NO : 760 2165136 
5770 ARMADA DRIVE                 SE DECISION MADE: 26-MAY-16
CARLSBAD CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)
Dako North America, Inc.          510(k) NO: K160922(Special)
ATTN: Joel  Weisenberger          PHONE NO : 1 805 5665432 
6392 Via Real                     SE DECISION MADE: 03-MAY-16
Carpinteria CA  93013             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Certus 140 2.45GHz Ablation System
NEUWAVE MEDICAL, INC              510(k) NO: K160936(Special)
ATTN: DAN  KOSEDNAR               PHONE NO : 608 5121592 
3529 ANDERSON STREET              SE DECISION MADE: 04-MAY-16
MADISON WI  53704                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Philips Efficia CMS200 Central Monitoring System
PHILIPS MEDICAL SYSTEMS           510(k) NO: K160951(Special)
ATTN: MARY  KRUITWAGEN            PHONE NO : 978 6594932 
3000 MINUTEMAN RD                 SE DECISION MADE: 05-MAY-16
ANDOVER MA  01810-1099            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alma Diode Tabletop Laser
ALMA LTD                          510(k) NO: K160952(Special)
ATTN: Ariela  Albalak             PHONE NO : 011 972 46275357 
14 Halamish St Caesarea IndustrialSE DECISION MADE: 05-MAY-16
Caesarea  IL 38900                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EsophyX® Z Device with SerosaFuse Fasteners and Accessories
ENDOGASTRIC SOLUTIONS, INC.       510(k) NO: K160960(Special)
ATTN: STEVEN J HOFFMAN            PHONE NO : 425 3079226 
18109 NE 76TH STREET SUITE 100    SE DECISION MADE: 01-MAY-16
REDMOND WA  98052                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Threshold Pedicular Fixation System, Palisade Pedicular Fixation System
SPINEOLOGY INC                    510(k) NO: K160980(Special)
ATTN: JACQUELINE A HAUGE          PHONE NO : 651 2568500 
7800 3RD STREET N, SUITE 600      SE DECISION MADE: 26-MAY-16
ST. PAUL MN  55128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xenco Medical Pedicle Screw System
XENCO MEDICAL, LLC                510(k) NO: K160986(Special)
ATTN: GUSTAVO  PRADO              PHONE NO : 858 2021505 
9930 MESA RIM DRIVE               SE DECISION MADE: 04-MAY-16
SAN DIEGO CA  92121               510(k) STATEMENT
                                                    

DEVICE: C2 CryoBalloon Focal Pear Catheter
C2 THERAPEUTICS, INC.             510(k) NO: K160994(Special)
ATTN: Theresa  Brandner-Allen     PHONE NO : 650 521592 
303 CONVENTION WAY, SUITE  1      SE DECISION MADE: 19-MAY-16
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biodesign Otologic Repair Graft
COOK BIOTECH INCORPORATED         510(k) NO: K161000(Special)
ATTN: PERRY W. GUINN              PHONE NO : 765 4973355 
1425 INNOVATION PLACE             SE DECISION MADE: 11-MAY-16
WEST LAFAYETTE IN  47909          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: True HD 3MOS Camera System
CONMED CORPORATION                510(k) NO: K161017(Special)
ATTN: Diair  Cantisani            PHONE NO : 508 9482084 
525 FRENCH ROAD                   SE DECISION MADE: 09-MAY-16
UTICA NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HydroMARK Breast Biopsy Site Marker
DEVICOR MEDICAL PRODUCTS, INC.    510(k) NO: K161021(Special)
ATTN: SHAWNA  ROSE                PHONE NO : 513 8649178 
300 E-BUSINESS WAY, FIFTH FLOOR   SE DECISION MADE: 05-MAY-16
Cincinnati OH  45241              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OsteoMed ExtremiLOCK Wrist Plating System
OSTEOMED                          510(k) NO: K161041(Special)
ATTN: KATHRYN  JAYNE              PHONE NO : 972 6774766 
3885 ARAPAHO ROAD                 SE DECISION MADE: 19-MAY-16
ADDISON TX  75001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Laser Helmet LH40-EVO
Theradome, Inc                    510(k) NO: K161046(Special)
ATTN: Tamim  Hamid                PHONE NO : 510 7140525 
4900 Hopyard Road, Suite 100      SE DECISION MADE: 12-MAY-16
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOGIQ P9 and LOGIQ P7
GE Healthcare                     510(k) NO: K161047(Special)
ATTN: Bryan  Behn                 PHONE NO : 414 7214214 
9900 Innovation Dr.               SE DECISION MADE: 05-MAY-16
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diagnostic Imaging Color LCD Monitor
NEC DISPLAY SOLUTIONS LTD.        510(k) NO: K161057(Traditional)
ATTN: SATORU  KOTANI              PHONE NO : 81 465 852384 
4-28, MITA 1-CHOME, MINATO-KU     SE DECISION MADE: 13-MAY-16
TOKYO  JP                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Escalade Legend Acetabular Shell
ORTHO DEVELOPMENT CORPORATION     510(k) NO: K161080(Special)
ATTN: Drew  Weaver                PHONE NO : 801 6193419 
12187 SOUTH BUSINESS PARK DRIVE   SE DECISION MADE: 17-MAY-16
DRAPER UT  84020                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers
IMMUNODIAGNOSTIC SYSTEMS LTD.     510(k) NO: K161082(Traditional)
ATTN: MICK  HENDERSON             PHONE NO : 44 019 15190660 
10 DIDCOT WAY, BOLDEN BUSINESS PARSE DECISION MADE: 17-MAY-16
BOLDON  GB NE35 9PD               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nanostim Introducer Kit
ST JUDE MEDICAL, INC.             510(k) NO: K161102(Special)
ATTN: Hassan  Labay               PHONE NO : 1 408 522622 
15900 VALLEY VIEW CT              SE DECISION MADE: 19-MAY-16
SYLMAR CA  91342                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EzDent-i / E2 / Prora View
EWOO SOFT CO., LTD.               510(k) NO: K161117(Special)
ATTN: YOUNG SEOK KIM              PHONE NO : 82 318 0156172 
801-HO, 6, SAMSUNG 1-RO 1-GIL     SE DECISION MADE: 13-MAY-16
HWASEONG-SI  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SonoSite iViz Ultrasound System
FUJIFILM SONOSITE,INC.            510(k) NO: K161119(Third Party - Traditional)
ATTN: Patricia   Liau             PHONE NO : 425 9516870 
21919 30th Dr SE                  SE DECISION MADE: 13-MAY-16
BOTHELL WA  98021-3904            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Baha 5 Power Sound Processor
Cochlear Americas                 510(k) NO: K161123(Special)
ATTN: Laura  Blair                PHONE NO : 303 7909010 
13059 E. Peakview Avenue          SE DECISION MADE: 20-MAY-16
Centennial CO  80111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OptiCross X, 40 MHz Coronary Imaging Catheter
Boston Scientific Corporation     510(k) NO: K161125(Special)
ATTN: Eric  Elliott               PHONE NO : 510 6241314 
47215 Lakeview Boulevard          SE DECISION MADE: 19-MAY-16
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITROS Chemistry Products Calibrator Kit 3
ORTHO-CLINICAL DIAGNOSTICS, INC.  510(k) NO: K161140(Abbreviated)
ATTN: MARLENE   HANNA             PHONE NO : 585 4534041 
100 INDIGO CREEK DRIVE            SE DECISION MADE: 20-MAY-16
ROCHESTER NY  14626-5101          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Seal Single-Use Biopsy Valve
ENDOCHOICE, INC.                  510(k) NO: K161167(Special)
ATTN: Daniel   Hoefer             PHONE NO : 678 7084743 
11810 WILLS ROAD                  SE DECISION MADE: 26-MAY-16
ALPHARETTA GA  30009              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Eclipse Hypodermic Needle
Becton, Dickinson and Company     510(k) NO: K161170(Special)
ATTN: Priyanka  Apte              PHONE NO : 201 8474608 
1 Becton Drive                    SE DECISION MADE: 27-MAY-16
Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARTOURA Breast Tissue Expanders with Smooth Surface
MENTOR WORLDWIDE LLC              510(k) NO: K161176(Special)
ATTN: LAURA C. VELLUCCI           PHONE NO : 908 2183002 
33 TECHNOLOGY DRIVE               SE DECISION MADE: 23-MAY-16
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: G7 Dual Mobility System, Active Articulation System
Biomet, Inc                       510(k) NO: K161190(Special)
ATTN: Emily  Manuel               PHONE NO : 574 3719632 
56 East Bell Drive                SE DECISION MADE: 26-MAY-16
Warsaw IN  46581-0587             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Soehendra Stent Retriever
WILSON-COOK MEDICAL, INC.         510(k) NO: K161203(Special)
ATTN: DORIS A. HAWKS              PHONE NO : 336 7440157 6293
4900 BETHANIA STATION ROAD        SE DECISION MADE: 04-MAY-16
WINSTON-SALEM NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CROSSER CTO Recanalization Catheter
Bard Peripheral Vacular, Inc.     510(k) NO: K161208(Special)
ATTN: Melanie  Hadlock            PHONE NO : 800 3214524 
1625 West 3rd Street              SE DECISION MADE: 24-MAY-16
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cirona 6400
DEVON MEDICAL PRODUCTS            510(k) NO: K161209(Special)
ATTN: ROCCO  BRAVOCO              PHONE NO : 866 4460092 4235
1100 FIRST AVENUE                 SE DECISION MADE: 31-MAY-16
KING OF PRUSSIA PA  19119         510(k) STATEMENT
                                                    

DEVICE: Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug
Cook Biotech Incorporated         510(k) NO: K161221(Special)
ATTN: Perry W. Guinn              PHONE NO : 765 4973355 
1425 Innovation Place             SE DECISION MADE: 26-MAY-16
West Lafayette IN  47906          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Radiance Ultra Series ZeroWire Embedded
NDS SURGICAL IMAGING, LLC.        510(k) NO: K161228(Special)
ATTN: Jim   Leng                  PHONE NO : 408 7760085 
5750 HELLYER AVE                  SE DECISION MADE: 26-MAY-16
SAN JOSE CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mammo Tomosynthesis (MDMG-5221)
BARCO N.V.                        510(k) NO: K161229(Special)
ATTN: Lieven  De Wandel           PHONE NO : 32 562 33459 
PRESIDENT KENNEDYPARK 35          SE DECISION MADE: 18-MAY-16
Kortrijk  BE 8500                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ez3D-i / E3
EWOO SOFT CO., LTD.               510(k) NO: K161246(Special)
ATTN: Young  Seok  Kim            PHONE NO : 82 31 80156172 
801-HO, 6, SAMSUNG 1-RO 1-GIL     SE DECISION MADE: 31-MAY-16
HWASEONG-SI  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acclarix AX8 Diagnostic Ultrasound System
EDAN INSTRUMENTS INC.             510(k) NO: K161300(Special)
ATTN: ERICO  LI                   PHONE NO : 86 755 26858736 
3/F - B, NANSHAN MEDICAL EQUIPMENTSE DECISION MADE: 31-MAY-16
SHENZHEN  CN 518067               510(k) SUMMARY AVAILABLE FROM FDA

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