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  1. 510(k) Clearances

February 2017 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD February 2017


DEVICE: BEMER Classic Set, BEMER Pro-Set
BEMER Int. AG                     510(k) NO: K151834(Traditional)
ATTN: Sven  Bieler                PHONE NO : 423 3999 3999 
Austrasse 15                      SE DECISION MADE: 22-FEB-17
Triesen  LI 9495                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer
GLOBUS MEDICAL INC.               510(k) NO: K152022(Traditional)
ATTN: KELLY  J. BAKER             PHONE NO : 610 9301800 1670
VALLEY FORGE BUSINESS CENTER 2560 SE DECISION MADE: 22-FEB-17
AUDUBON PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ActiPatch(R)
BIOELECTRONICS CORPORATION        510(k) NO: K152432(Traditional)
ATTN: ANDREW  WHELAN              PHONE NO : 301 8744890 
4539 METROPOLITAN COURT           SE DECISION MADE: 03-FEB-17
FREDERICK MD  21704               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PUREtrace™
NEMO HEALTHCARE BV                510(k) NO: K153262(Traditional)
ATTN: Aron  Wierts                PHONE NO : 31 40 7516150 
De Run 4630 5504 DB               SE DECISION MADE: 07-FEB-17
Veldhoven  NL                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System
ANDON HEALTH CO., LTD             510(k) NO: K153561(Traditional)
ATTN: Yi   Liu                    PHONE NO : 86 22 60526161 
No. 3 JinPing Street,Ya' An Road, SE DECISION MADE: 16-FEB-17
TIANJIN  CN 300190                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set
COOK INCORPORATED                 510(k) NO: K160200(Traditional)
ATTN: Kotei  Aoki                 PHONE NO : 812 3353575 102630
750 DANIELS WAY                   SE DECISION MADE: 17-FEB-17
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DT-100
Mediana Co., Ltd.                 510(k) NO: K160358(Traditional)
ATTN: Min-hye  Kim                PHONE NO : 82 33 7425400 
132, Donghwagongdan-ro, Munmak-eupSE DECISION MADE: 24-FEB-17
Wonju-si  KR 220-801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FB-U Hemodialyzer
NIPRO MEDICAL CORPORATION         510(k) NO: K160444(Traditional)
ATTN: JESSICA  OSWALD-MCLEOD      PHONE NO : 305 5997174 
3150 NW 107TH AVE.                SE DECISION MADE: 08-FEB-17
DORAL FL  33172                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set
KOBOLD, LLC                       510(k) NO: K160610(Traditional)
ATTN: Brian  Stoddart             PHONE NO : 509 9989419 
PO BOX 1994                       SE DECISION MADE: 13-FEB-17
VERADALE WA  99037                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GenNarino
SALIWELL LTD.                     510(k) NO: K160799(Traditional)
ATTN: BEN Z. BEISKI               PHONE NO : 972 353 47592 
65 HATAMAR ST.                    SE DECISION MADE: 17-FEB-17
HARUTZIM  IL 6091700              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Titan 3W
TZORA ACTIVE SYSTEMS LTD.         510(k) NO: K160835(Traditional)
ATTN: Adi  Shemer                 PHONE NO : 972 299 08207 
                                  SE DECISION MADE: 02-FEB-17
Kibbutz Tzora  IL 9980300         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM
MEDINET SRL                       510(k) NO: K160837(Traditional)
ATTN: STEFANO   BERNUCCI          PHONE NO : 39 02 34530290 
VIA LONDONIO, 12                  SE DECISION MADE: 23-FEB-17
MILANO  IT 20154                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HF 718BD X-Ray System
ARQUILLA, INC. DBA X-CEL X-RAY COR510(k) NO: K160857(Traditional)
ATTN: GUIDO  ARQUILLA             PHONE NO : 815 4552470 
5220 WALLER ST. STE 1             SE DECISION MADE: 24-FEB-17
CRYSTAL LAKE IL  60012            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PC ECG
EDAN INSTRUMENTS, INC.            510(k) NO: K160876(Traditional)
ATTN: QUEENA  CHEN                PHONE NO : 86 755 26858736 
3/F - B NANSHAN MEDICAL EQUIPMENTSSE DECISION MADE: 15-FEB-17
SHENZHEN  CN 518067               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JUVORA Dental Disc, Ceramill PEEK by JUVORA
JUVORA                            510(k) NO: K160918(Traditional)
ATTN: SELINA  SALTHOUSE           PHONE NO : 01253 898001 
TECHNOLOGY CENTRE, HILLHOUSE INTERSE DECISION MADE: 13-FEB-17
THORNTON-CLEVELEYS  GB FY5 4QD    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UC-CARE NaviGo Workstation
UC-CARE LTD.                      510(k) NO: K160934(Traditional)
ATTN: TOMER  SCHATZBERGER         PHONE NO : 972 4 9097427 
APOLLO BLDG., NEW INDUSTRIAL ZONE,SE DECISION MADE: 06-FEB-17
YOKNEAM  IL 20692                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: priti multidisc ZrO2 High Translucent
PRITIDENTA GMBH                   510(k) NO: K161025(Traditional)
ATTN: MAGDALENA  GEIGENBERGER     PHONE NO : 49 071 1320356046 
MEISENWEG 37                      SE DECISION MADE: 03-FEB-17
LEINFELDEN-ECHTERDINGEN   DE 70771510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Telemetry Transmitter
Edan Instruments, Inc.            510(k) NO: K161056(Traditional)
ATTN: Queena  Chen                PHONE NO : 86 755 26857836 
3/F-B, Nanshan Medical Equipments SE DECISION MADE: 03-FEB-17
Shenzhen  CN 518067               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves, Black
PT. MAJA AGUNG LATEXINDO          510(k) NO: K161099(Traditional)
ATTN: IMELDA  SHAMROCK            PHONE NO : 62 61 8459170 
JALAN UTAMA NO. 98 PUJIMULYO      SE DECISION MADE: 23-FEB-17
SUNGGAL-DELI SERDANG  ID 20352    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: US SA Implant System
OSSTEM IMPLANT CO.,LTD.           510(k) NO: K161103(Traditional)
ATTN: Hee  Kwon                   PHONE NO : 82 51 8502575 
66-16, BANSONG-RO 513BEON-GIL, HAESE DECISION MADE: 02-FEB-17
Busan  KR 612-070                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMR TT Metal Back Glenoid, Bone Graft instruments
LIMACORPORATE S.P.A.              510(k) NO: K161120(Traditional)
ATTN: Emanuele  Buttazzoni        PHONE NO : 39 043 2945511 
VIA NAZIONALE 52                  SE DECISION MADE: 21-FEB-17
VILLANOVA DI SAN DANIELE  IT 33038510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XSmart iQ
DENTSPLY SIRONA                   510(k) NO: K161213(Traditional)
ATTN: HELEN  LEWIS                PHONE NO : 717 4871332 
221 WEST PHILADELPHIA STREET SUITESE DECISION MADE: 10-FEB-17
York PA  17404                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Revision Femoral Stem
LIMACORPORATE S.P.A.              510(k) NO: K161226(Traditional)
ATTN: EMANUELE  BUTTAZZONI        PHONE NO : 39 0432 945511 
VIA NAZIONALE 52                  SE DECISION MADE: 10-FEB-17
VILLANOVA DI SAN DANIELE  IT 33038510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
INOVA DIAGNOSTICS, INC.           510(k) NO: K161258(Traditional)
ATTN: Gabriella   Lakos           PHONE NO : 858 5869900 1393
9900 OLD GROVE ROAD               SE DECISION MADE: 03-FEB-17
SAN DIEGO CA  92131               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Life Spine Metatarsal Hemi Implant
LIFE SPINE INC.                   510(k) NO: K161279(Traditional)
ATTN: RANDY  LEWIS                PHONE NO : 847 8846117 
13951 S QUALITY DRIVE             SE DECISION MADE: 01-FEB-17
HUNTLEY IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: George King Coumadin Plasma
GEORGE KING BIO-MEDICAL, INC.     510(k) NO: K161316(Traditional)
ATTN: BARBARA  YOUNG              PHONE NO : 913 4595464 
11771 W. 112TH ST                 SE DECISION MADE: 23-FEB-17
OVERLAND PARK KS  66210           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RASL Repair Kit 
RADICLE ORTHOPAEDICS, INC.        510(k) NO: K161334(Traditional)
ATTN: EDWARD  ROSENWASSER         PHONE NO : 704 8437852 
PO BOX 7551                       SE DECISION MADE: 09-FEB-17
NEW YORK NY  10150                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dual Top Screw System
JEIL MEDICAL CORPORATION          510(k) NO: K161335(Traditional)
ATTN: SEUNGYOUNG  LEE             PHONE NO : 82 2 8503533 
702, 703, 704, 705, 706, 804, 805,SE DECISION MADE: 23-FEB-17
SEOUL  KR 08378                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: U2 Total Knee System, PSA Tibial Insert
UNITED ORTHOPEDIC CORPORATION     510(k) NO: K161360(Traditional)
ATTN: KAREN  HO                   PHONE NO : 886 3 5773351 2212
NO 57, PARK AVE 2, SCIENCE PARK   SE DECISION MADE: 01-FEB-17
HSINCHU  TW 300                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sonoma Fifth Metatarsal Repair System
SONOMA ORTHOPEDIC PRODUCTS, INC.  510(k) NO: K161371(Traditional)
ATTN: Rick   Epstein              PHONE NO : 
1388 BUSCH PARKWAY                SE DECISION MADE: 24-FEB-17
Buffalo Grove IL  60089           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Red Head Collection Device, The Jordy Connection System
MIAMI FAT SUPPLY                  510(k) NO: K161372(Traditional)
ATTN: Donnell Mark Jordan         PHONE NO : 352 5576979 
1510 MAX HOOKS RD., SUITE F       SE DECISION MADE: 24-FEB-17
Groveland FL  34736               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Care Cycle Connect Application
RESPIRONICS, INC.                 510(k) NO: K161411(Traditional)
ATTN: Colleen   Witt              PHONE NO : 724 3874146 
1001 MURRY RIDGE LN.              SE DECISION MADE: 17-FEB-17
MURRYSVILLES PA  15668            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Low Profile Balloon Feeding Device
APPLIED MEDICAL TECHNOLOGY, INC.  510(k) NO: K161413(Traditional)
ATTN: Michelle   Scott            PHONE NO : 440 7174000 
8006 KATHERINE BLVD               SE DECISION MADE: 09-FEB-17
BRECKSVILLE OH  44141             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SteriTite Containers System & MediTray Products
CASE MEDICAL, INC.                510(k) NO: K161415(Traditional)
ATTN: TANIA  LUPU                 PHONE NO : 201 3131999 
19 EMPIRE BLVD.                   SE DECISION MADE: 10-FEB-17
SOUTH HACKENSACK NJ  07606        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyNeWT Negative Pressure Wound Therapy System
Stortford Medical LLC             510(k) NO: K161432(Traditional)
ATTN: Chris  Daughtery            PHONE NO : 609 2359292 
295 Princeton Hightstown Road, UniSE DECISION MADE: 08-FEB-17
West Windsor NJ  08550            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST Gram Negative Cefotaxime (<=0.25 -="">=64 ug/mL)
BIOMERIEUX, INC.                  510(k) NO: K161437(Traditional)
ATTN: KAREN  RUSSELL              PHONE NO : 314 7318639 
595 ANGLUM ROAD                   SE DECISION MADE: 16-FEB-17
HAZELWOOD MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Transformair Indoor Air Purifier
Transformair, LLC                 510(k) NO: K161468(Third Party - Traditional)
ATTN: Jaya  Rao                   PHONE NO : 352 8713803 
3802 Spectrum Blvd Suite 143      SE DECISION MADE: 08-FEB-17
Tampa FL  33612                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ZIIP Device
ZIIP,LLC                          510(k) NO: K161484(Traditional)
ATTN: David  Mason                PHONE NO : 408 2341005 
1871 Trestle Glen Rd.,            SE DECISION MADE: 24-FEB-17
Piedmont CA  94610                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Scopis Hybrid Navigation System EM
Scopis GmbH                       510(k) NO: K161491(Traditional)
ATTN: Christopher  Ozbek          PHONE NO : 49 30 20169380 
Heinrich-Heine-Platz 10           SE DECISION MADE: 09-FEB-17
Berlin  DE 10179                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEG-TORQ
MICRO-NX Co., Ltd                 510(k) NO: K161500(Traditional)
ATTN: J. K. Jung                  PHONE NO : 83 53 6110071 
37, Dalseong2chadong 3-ro, Guji-mySE DECISION MADE: 22-FEB-17
Daegu  KR 711-891                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 -="">= 32 mcg/mL)
BIOMERIEUX, INC                   510(k) NO: K161510(Traditional)
ATTN: CHERECE L. JONES            PHONE NO : 314 7318684 
595 ANGLUM RD.                    SE DECISION MADE: 13-FEB-17
HAZELWOOD MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TAP Blood Collection Device 
Seventh Sense Biosystems, Inc.    510(k) NO: K161521(Traditional)
ATTN: TIM  RICHARDS               PHONE NO : 617 5477246 
200 BOSTON AVE SUITE 3700         SE DECISION MADE: 16-FEB-17
MEDFORD  MA  02155                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EasyOne Pro Respiratory Analysis System
NDD MEDIZINTECHNIK AG             510(k) NO: K161534(Traditional)
ATTN: N/A  N/A                    PHONE NO : 
TECHNOPARKSTRASSE 1               SE DECISION MADE: 22-FEB-17
ZURICH  CH 8005                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe
Becton Dickinson and Company      510(k) NO: K161552(Special)
ATTN: John  Blewitt               PHONE NO : 201 8475473 
1 Becton Drive                    SE DECISION MADE: 02-FEB-17
Franklin Lakes NJ  07045          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arm-Type Fully Automatic Digital Blood Pressure Monitor
SEJOY ELECTRONICS & INSTRUMENTS CO510(k) NO: K161577(Special)
ATTN: Ren  Yunhua                 PHONE NO : 86 571 81957767 
Building 2, No. 202, Zhenzhong RoaSE DECISION MADE: 08-FEB-17
Hang zhou  CN 310030              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Watch-PAT200U
ITAMAR MEDICAL, LTD.              510(k) NO: K161579(Traditional)
ATTN: Koby   Sheffy               PHONE NO : 972 4 6177000 
9 HALAMISH ST.                    SE DECISION MADE: 24-FEB-17
CAESAREA  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Memodyn Staple
AUSTIN & ASSOCIATES, INC./TELOS ME510(k) NO: K161587(Special)
ATTN: AL  AUSTIN                  PHONE NO : 410 9039038 
212 COPPERWOOD COURT              SE DECISION MADE: 01-FEB-17
MILLERSVILLE MD  21108            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH
TERUMO EUROPE N.V.                510(k) NO: K161606(Traditional)
ATTN: M.J.  AERTS                 PHONE NO : 32 16 381211 
INTERLEUVENLAAN 40                SE DECISION MADE: 10-FEB-17
LEUVEN  BE 3001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VISULUX
CARL ZEISS MEDITEC AG             510(k) NO: K161607(Traditional)
ATTN: Christian   Muenster        PHONE NO : 49 3614 220647 
GOESCHWITZER STRASSE 54-52        SE DECISION MADE: 23-FEB-17
JENA  DE 07745                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw 
Synthes USA Products, LLC         510(k) NO: K161616(Traditional)
ATTN: Nina  Rudolph               PHONE NO : 610 7196935 
1301 Goshen Parkway               SE DECISION MADE: 16-FEB-17
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CRYLREX
SM ENG CO., LTD                   510(k) NO: K161629(Traditional)
ATTN: SOON-GU  LEE                PHONE NO : 82 51 3058016 
46, NAKDONG-DAERO 1302BEON-GIL    SE DECISION MADE: 10-FEB-17
SASANG-GU  KR                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: On1 Concept
NOBEL BIOCARE AB                  510(k) NO: K161655(Traditional)
ATTN: CHARLEMAGNE  CHUA           PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, VASTRA HAMNGASE DECISION MADE: 28-FEB-17
GOTEBORG  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis
STRYKER SUSTAINABILITY SOLUTIONS  510(k) NO: K161693(Traditional)
ATTN: Scott  English              PHONE NO : 480 7635333 
1810 W. Drake Dr.                 SE DECISION MADE: 23-FEB-17
Tempe AZ  85283                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndyGel
EndyMed Medical Ltd.              510(k) NO: K161715(Traditional)
ATTN: Yoram  Levy                 PHONE NO : 972 4 6309100 
12 Leshem Street, North IndustrialSE DECISION MADE: 07-FEB-17
Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SLIT LAMP, Model: YF-100
CHONGQING YEASN SCIENCE-TECHNOLOGY510(k) NO: K161764(Traditional)
ATTN: BING  HU                    PHONE NO : 86 23 62797666 8050
5 DANLONG ROAD                    SE DECISION MADE: 16-FEB-17
NAN'AN DISTRICT  CN 400060        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial
BECTON DICKINSON                  510(k) NO: K161810(Traditional)
ATTN: Ashanti C. Brown            PHONE NO : 410 3164766 
7 LOVETON CIRCLE, MC 694          SE DECISION MADE: 09-FEB-17
Sparks MD  21152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medela Low Dose Enteral Syringe
Medela, Inc.                      510(k) NO: K161811(Traditional)
ATTN: Fergie  Ferguson            PHONE NO : 714 2570470 
785 Challenger Street             SE DECISION MADE: 15-FEB-17
Brea CA  92821                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Family of Steam sterilizers B17 B22 Series
CEFLA S.C.                        510(k) NO: K161848(Traditional)
ATTN: Silvia  Sansavini           PHONE NO : 39 542 653438 
VIA SELICE PROVINCIALE, 23/A      SE DECISION MADE: 23-FEB-17
IMOLA  IT 40026                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
AESCULAP INC.                     510(k) NO: K161853(Traditional)
ATTN: KATHY A. RACOSKY            PHONE NO : 610 9849291 
3773 CORPORATE PARKWAY            SE DECISION MADE: 27-FEB-17
CENTER VALLEY PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MagnetOs
XPAND BIOTECHNOLOGY BV            510(k) NO: K161859(Traditional)
ATTN: YVONNE P. BOVELL            PHONE NO : 31 302 297280 
PROFESSOR BRONKHORSTLAAN 10D, BUILSE DECISION MADE: 24-FEB-17
BILTHOVEN  NL 3723 MB             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TG-970P CO2 Sensor Kit
NIHON KOHDEN CORPORATION          510(k) NO: K161860(Traditional)
ATTN: THOMAS  BENTO               PHONE NO : 949 6809048 
1-31-4 NISHIOCHIAI, SHINJUKU-KU   SE DECISION MADE: 24-FEB-17
TOKYO  JP 161-8560                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: APTUS® Coronoid 2.0
Medartis AG                       510(k) NO: K161861(Traditional)
ATTN: Andrea  Schweizer           PHONE NO : 41 61 6333434 
Hochbergerstrasse 60E             SE DECISION MADE: 09-FEB-17
Basel  CH CH-4057                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SurgTech Trauma System
SURGTECH INC                      510(k) NO: K161894(Traditional)
ATTN: XUEGONG  YU                 PHONE NO : 216 4212613 
24600 CENTER RIDGE ROAD, SUITE 195SE DECISION MADE: 21-FEB-17
WESTLAKE OH  44145                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TrapLiner catheter
Vascular Solutions, Inc.          510(k) NO: K161901(Traditional)
ATTN: Beka  Vite                  PHONE NO : 763 6575732 
6464 Sycamore Court North         SE DECISION MADE: 03-FEB-17
Minneapolis MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pressure Therapy System
XIAMEN SENYANG CO., LTD.          510(k) NO: K161907(Traditional)
ATTN: XINJIE  SHAO                PHONE NO : 086 1379 9762941 
4-5 FLOOR, XINGBEI INDUSTRY, NO 95SE DECISION MADE: 23-FEB-17
XINGLIN XIAMEN  CN 361000         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ND YAG Q-switch Laser Therapy Machine
Beijing ADSS Development Co., Ltd 510(k) NO: K161926(Traditional)
ATTN: Gao  Yurong                 PHONE NO : 86 10 83625120 
F6, Xiandao Bldg., Jinyuan Rd. 36 SE DECISION MADE: 22-FEB-17
Beijing  CN 102628                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReDe Mask
TereoPneuma                       510(k) NO: K161953(Traditional)
ATTN: Warren G. Young             PHONE NO : 858 8425036 
13223 Black Mountain Rd., Ste 1-22SE DECISION MADE: 17-FEB-17
San Diego CA  92129               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fuselier Intraoral Nighttime Device (FIND)
FUSELIER ENTERPRISES, LLC         510(k) NO: K161980(Traditional)
ATTN: BRIAN  FUSELIER             PHONE NO : 407 9630553 
2051 MOHICAN TRAIL                SE DECISION MADE: 07-FEB-17
MAITLAND FL  32751                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure
DIO CORPORATION                   510(k) NO: K161987(Traditional)
ATTN: SANGIN  PARK                PHONE NO : 82 51 7457789 
66, CENTUM SEO-RO                 SE DECISION MADE: 21-FEB-17
BUSAN  KR 48058                   510(k) STATEMENT
                                                    

DEVICE: 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE
Amend Surgical, Inc.              510(k) NO: K161996(Traditional)
ATTN: Robert  Lane                PHONE NO : 352 2264988 
13859 Progress Blvd. Suite 300    SE DECISION MADE: 16-FEB-17
Alachua FL  32615                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STERRAD NX Sterilizer
Advanced Sterilization Products   510(k) NO: K162007(Special)
ATTN: Nazanin  Yacobi             PHONE NO : 949 7898672 
33 Technology Dr.                 SE DECISION MADE: 16-FEB-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)
BLUEPOINT MEDICAL GMBH & CO. KG   510(k) NO: K162014(Traditional)
ATTN: BERND  LINDNER              PHONE NO : 49 388 235488000 
AN DER TRAVE 15                   SE DECISION MADE: 06-FEB-17
SELMSDORF  DE 23923               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surface Applicator Set
Varian Medical Systems, Inc.      510(k) NO: K162018(Traditional)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
911 Hansen Way                    SE DECISION MADE: 28-FEB-17
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arrowhead Mini-Rail Fixator
Arrowhead DE, LLC                 510(k) NO: K162032(Traditional)
ATTN: Thomas J. Twardzik          PHONE NO : 901 8534366 
328 Poplar View Lane East, Suite 2SE DECISION MADE: 21-FEB-17
Collierville TN  38017            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OptosAdvance 4.0 Software
Optos Plc                         510(k) NO: K162039(Traditional)
ATTN: Paul  Burns                 PHONE NO : 44 0 1383843300 
Queensferry House, Carnegie CampusSE DECISION MADE: 08-FEB-17
Dunfermline  GB KY11 8GR          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IllumiFlow Laser Cap
EGLOBAL, LLC                      510(k) NO: K162071(Traditional)
ATTN: WAYNE  DESTEFANO            PHONE NO : 877 3645242 
10115 E BELL RD STE 107           SE DECISION MADE: 24-FEB-17
SCOTTSDALE AZ  85260              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental Implants OKTAGON Tissue Level and Bone Level
HAGER & MEISINGER GMBH            510(k) NO: K162073(Traditional)
ATTN: MELANIE  MAY                PHONE NO : 49 213 12012292 
HANSEMANNSTRASSE 10               SE DECISION MADE: 24-FEB-17
NEUSS  DE 41468                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blood Pressure Monitor
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K162089(Traditional)
ATTN: LEI  CHEN                   PHONE NO : 86 10 88798300 6020
NO.9 SHUANGYUAN ROAD, BADACHU HI-TSE DECISION MADE: 10-FEB-17
BEIJING  CN 100041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IBS Implant System II
InnoBioSurg Co., Ltd.             510(k) NO: K162099(Traditional)
ATTN: Bo-reum  Yoo                PHONE NO : 82 42 9332879 
44-19, Techno 10-ro, Yuseong-gu   SE DECISION MADE: 15-FEB-17
Daejeon  KR 305-510               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Micro-current Wrinkle Reduction Facial service, model EP-400
Li-Tek Electronic Technology Corpo510(k) NO: K162106(Traditional)
ATTN: Barry  Yuan                 PHONE NO : 86 0769 83117755 
No.8~13,the industrial park of JinSE DECISION MADE: 03-FEB-17
Dongguan  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iHealth Wireless Blood Pressure Monitor
ANDON HEALTH CO.,LTD              510(k) NO: K162144(Abbreviated)
ATTN: Liu  Yi                     PHONE NO : 86 22 6052616190 
NO 3  JIN PING STREET YA AN RD NANSE DECISION MADE: 01-FEB-17
TIANJIN  CN 300190                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Porcine Anorganic Bone Mineral in Delivery Applicator
Collagen Matrix, Inc.             510(k) NO: K162158(Traditional)
ATTN: Peggy  Hansen               PHONE NO : 201 4051477 
15 Thornton Road                  SE DECISION MADE: 09-FEB-17
Oakland NJ  07436                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
SEBIA                             510(k) NO: K162281(Traditional)
ATTN: KAREN  ANDERSON             PHONE NO : 770 4463707 
1705 CORPORATE DRIVE SUITE 400    SE DECISION MADE: 17-FEB-17
NORCROSS GA  30093                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DCM Kyphoplasty System
Dragon Crown Medical Co., Ltd.    510(k) NO: K162283(Traditional)
ATTN: Zhi Yong Song               PHONE NO : 86 531 81217228 
6F, Kehui Building, No. 109, ShunhSE DECISION MADE: 06-FEB-17
Jinan  CN 250101                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EasyClip Xpress
RESTORE SURGICAL LLC dba Instratek510(k) NO: K162321(Traditional)
ATTN: JEFF  SEAVEY                PHONE NO : 1 281 8908020 
15200 Middlebrook Drive, Suite G  SE DECISION MADE: 10-FEB-17
Houston TX  77058                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
CEPHEID                           510(k) NO: K162331(Traditional)
ATTN: SCOTT A. CAMPBELL           PHONE NO : 847 2283299 
904 CARIBBEAN DRIVE               SE DECISION MADE: 09-FEB-17
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T-Cuff
Terumo BCT, Inc.                  510(k) NO: K162365(Traditional)
ATTN: Nithya  Rajan               PHONE NO : 303 2314402 
10811 W. Collins Ave.             SE DECISION MADE: 16-FEB-17
Lakewood CO  80215                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)
CURASEAL, INC.                    510(k) NO: K162388(Traditional)
ATTN: HAROLD F. CARRISON          PHONE NO : 408 5658787 
2231 CALLE DE LUNA                SE DECISION MADE: 03-FEB-17
SANTA CLARA CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AlignMATE™ Lapidus Arthrodesis System
ARTHROSURFACE, INC.               510(k) NO: K162391(Special)
ATTN: PHANI  PUPPALA              PHONE NO : 508 5203003 
28 FORGE PARKWAY                  SE DECISION MADE: 21-FEB-17
FRANKLIN MA  02038                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The ViewRay (MRIdian) Linac System
VIEWRAY INCORPORATED              510(k) NO: K162393(Traditional)
ATTN: SEAN  DELANEY               PHONE NO : 650 2520969 
2 THERMO FISHER WAY               SE DECISION MADE: 24-FEB-17
OAKWOOD VILLAGE OH  44146         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 4CIS® Marlin ACIF Cage System
SOLCO BIOMEDICAL CO., LTD.        510(k) NO: K162402(Traditional)
ATTN: KIM  IL                     PHONE NO : 82 31 6644101 
154 SEOTAN-RO, SEOTAN-MYEON       SE DECISION MADE: 16-FEB-17
PYEONGTAEK  KR 17704              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AxSOS 3 Ti; Stryker Plating System
STRYKER GMBH                      510(k) NO: K162439(Traditional)
ATTN: Irene  Bacalocostantis      PHONE NO : 201 8316797 
325 CORPORATE DRIVE               SE DECISION MADE: 03-FEB-17
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PicoWay Laser System
SYNERON CANDELA CORPORATION       510(k) NO: K162454(Traditional)
ATTN: Ruthie  Amir                PHONE NO : 508 3587400 330
530 BOSTON POST ROAD              SE DECISION MADE: 01-FEB-17
Wayland MA  01778                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
CEPHEID                           510(k) NO: K162456(Traditional)
ATTN: SCOTT A. CAMPBELL           PHONE NO : 847 2283299 
904 CARIBBEAN DRIVE               SE DECISION MADE: 13-FEB-17
SUNNYVALE CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Twin-Pass Torque
VASCULAR SOLUTIONS, INC.          510(k) NO: K162467(Traditional)
ATTN: LISA  GALLATIN              PHONE NO : 763 6564300 
6464 Sycamore Court North         SE DECISION MADE: 01-FEB-17
Minneapolis MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smart Pain Reliever, Model LT5019
SHENZHEN DONGDIXIN TECHNOLOGY CO.,510(k) NO: K162479(Traditional)
ATTN: TRUMAN  SHEN                PHONE NO : 86 075 527652471 
NO. 3 BUILDING XILIBAIMANG XUSHENGSE DECISION MADE: 08-FEB-17
SHENZHEN  CN 518108               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RF1400 Active Compression Wrap
RECOVERY FORCE LLC                510(k) NO: K162481(Traditional)
ATTN: Jeff  Schwegman             PHONE NO : 866 6046458 
12175 VISIONARY WAY, SUITE 540    SE DECISION MADE: 16-FEB-17
FISHERS IN  46038                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lung Nodule Assessment and Comparison Option (LNA)
Philips Medical Systems Nederland 510(k) NO: K162484(Traditional)
ATTN: Yoram  Levy                 PHONE NO : 1 800 7229377 
Veenpluis 4-6                     SE DECISION MADE: 23-FEB-17
5684 PC Best  NL 3088900          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
HARTALEGA SDN. BHD.               510(k) NO: K162491(Traditional)
ATTN: KUAN KAM HON                PHONE NO : 603 62771733 
DATARAN SD PJU 9                  SE DECISION MADE: 08-FEB-17
BANDAR SERI DAMANSARA  MY 52200   510(k) STATEMENT
                                                    

DEVICE: KerraCel Ag Gelling Fiber Silver Dressing
Exciton Technologies Inc.         510(k) NO: K162508(Traditional)
ATTN: Melanie  Ussyk              PHONE NO : 780 2485868 
10230 Jasper Ave., Suite 4147     SE DECISION MADE: 13-FEB-17
Edmonton  CA T5J 4P6              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord
KERR CORPORATION                  510(k) NO: K162536(Traditional)
ATTN: MOHAMMAD SAAD ANSARI        PHONE NO : 909 9625644 
1717 W. COLLINS AVE               SE DECISION MADE: 03-FEB-17
ORANGE CA  92867                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VIA 17 Microcatheter
SEQUENT MEDICAL, INC.             510(k) NO: K162565(Traditional)
ATTN: BETHANY  BARRETT            PHONE NO : 949 8309600 
11A COLUMBIA                      SE DECISION MADE: 18-FEB-17
ALISO VIEJO CA  92677             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Miromatrix Biological Mesh TW
Miromatrix Medical Inc.           510(k) NO: K162570(Traditional)
ATTN: Jeff  Ross                  PHONE NO : 763 4588801 
18683 Bearpath Trail              SE DECISION MADE: 16-FEB-17
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bashan TDP Heat Lamp
Chogqing YUHE Medical Instruments 510(k) NO: K162590(Traditional)
ATTN: Liu  Yong                   PHONE NO : 86 23 65462778 
No.104-8 City Garden Mid Road, ShaSE DECISION MADE: 14-FEB-17
Chongqing  CN 400038              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClariFix Device
ARRINEX, INC.                     510(k) NO: K162608(Traditional)
ATTN: VAHID  SAADAT               PHONE NO : 408 8022052 
1755 EAST BAYSHORE RD, STE 26     SE DECISION MADE: 14-FEB-17
REDWOOD CITY CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PeriFLEX
SPIRATION, INC.                   510(k) NO: K162611(Traditional)
ATTN: Aadarsh S Viswanathan       PHONE NO : 425 6365535 
6675 185TH AVE NE                 SE DECISION MADE: 09-FEB-17
REDMOND WA  98052                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pre-Formed Penile Silicone Block
INTERNATIONAL MEDICAL DEVICES, INC510(k) NO: K162624(Traditional)
ATTN: JAMES  ELIST                PHONE NO : 310 6522600 
717 NORTH MAPLE DRIVE             SE DECISION MADE: 01-FEB-17
BEVERLY HILLS CA  90210           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Proficient™ Posterior Cervical Spine System
Spine Wave, Inc.                  510(k) NO: K162639(Traditional)
ATTN: Sanja  Jahr                 PHONE NO : 203 7121870 
3 Enterprise Drive, Suite 210     SE DECISION MADE: 07-FEB-17
Shelton CT  06484                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fully Automatic Electronic Blood Pressure Monitor
ANDON HEALTH CO.,LTD              510(k) NO: K162668(Abbreviated)
ATTN: LIU  YI                     PHONE NO : 86 226 0526161 9060
NO.3 JIN PING STREET, YA AN ROAD NSE DECISION MADE: 14-FEB-17
TIANJIN  CN 300190                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RSM 1824C with RConsole1
DRTECH CORPORATION                510(k) NO: K162670(Traditional)
ATTN: CHOUL-WOO  SHIN             PHONE NO : 82 317 797783 
SUITE NO.2, 3 FLOOR, 29, DUNCHON-DSE DECISION MADE: 23-FEB-17
SEONGNAM-SI  KR 13230             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RehaStim 2
HASOMED GmbH                      510(k) NO: K162683(Traditional)
ATTN: Matthias  Ueltzen           PHONE NO : 49 391 6230112 
Paul-Ecke-Str. 1                  SE DECISION MADE: 03-FEB-17
Magdeburg  DE 39114               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal
Custom Orthopaedic Solutions, Inc.510(k) NO: K162697(Traditional)
ATTN: Keith  Grafmeyer            PHONE NO : 216 8005905 102
7100 Euclid Ave., Ste. 180        SE DECISION MADE: 10-FEB-17
Cleveland OH  44103               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload
TGS Medical Co., Ltd.             510(k) NO: K162710(Traditional)
ATTN: Hua  Cao                    PHONE NO : 86 512 86867776 
Building 17, No.8 Jinfeng Road, HiSE DECISION MADE: 09-FEB-17
Suzhou  CN 214163                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exactech® Equinoxe® Preserve Stem
EXACTECH INC                      510(k) NO: K162726(Traditional)
ATTN: Thomas  McNamara            PHONE NO : 352 3771140 
2320 NW 66TH COURT                SE DECISION MADE: 01-FEB-17
GAINESVILLE FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARTIA Reconstructive Tissue Matrix Perforated
LIFECELL CORPORATION              510(k) NO: K162752(Traditional)
ATTN: ANUJA  YARDI                PHONE NO : 908 9471100 
ONE MILLENNIUM WAY                SE DECISION MADE: 24-FEB-17
BRANCHBURG NJ  08876              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RTC 26-C Inline Aerosol Adapter
INSTRUMENTATION INDUSTRIES, INC.  510(k) NO: K162753(Traditional)
ATTN: Doris  Walter               PHONE NO : 412 8545668 
2990 INDUSTRIAL BLVD.             SE DECISION MADE: 28-FEB-17
BETHEL PARK PA  15102             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spine Wave Anterior Cervical Spine System
SPINE WAVE, INC.                  510(k) NO: K162760(Traditional)
ATTN: Amnon  Talmor               PHONE NO : 203 9449494 
3 ENTERPRISE DR SUITE 210         SE DECISION MADE: 16-FEB-17
SHELTON CT  06484                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EkoSonic Control Unit 4.0
BTG International, Inc.           510(k) NO: K162771(Traditional)
ATTN: CURTIS  JENSEN              PHONE NO : 425 4153122 
11911 N Creek Pkwy S              SE DECISION MADE: 24-FEB-17
Bothell WA  98011                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)
Medtronic, Inc.                   510(k) NO: K162774(Traditional)
ATTN: Harsh  Dharamshi            PHONE NO : 763 5058646 
8200 Coral Sea Street NE          SE DECISION MADE: 10-FEB-17
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROPHECY INVISION Preoperative Navigation Alignment System
Wright Medical Technology, Inc.   510(k) NO: K162795(Traditional)
ATTN: Tara  Conrad                PHONE NO : 901 8674367 
1023 Cherry Road                  SE DECISION MADE: 22-FEB-17
Memphis TN  37117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BLUEPRINT Patient Specific Instrumentation
TORNIER SAS                       510(k) NO: K162800(Traditional)
ATTN: Aymen  AZAIEZ               PHONE NO : 33 476 613500 
161 rue LAVOISIER                 SE DECISION MADE: 22-FEB-17
MONTBONNOT SAINT MARTIN  FR 38330 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Z-Span Plate System
Zavation, LLC                     510(k) NO: K162824(Traditional)
ATTN: Frankie  Cummins            PHONE NO : 601 9191119 
220 Lakeland Parkway              SE DECISION MADE: 17-FEB-17
Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VIDAS B.R.A.H.M.S. PCT (PCT)
bioMerieux, Inc                   510(k) NO: K162827(Traditional)
ATTN: John  Albright              PHONE NO : 314 7318546 
595 Anglum Rd.                    SE DECISION MADE: 23-FEB-17
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIS Software
Surgical Information Sciences, Inc510(k) NO: K162830(Traditional)
ATTN: Mark  Headrick              PHONE NO : 612 3358683 
60 South 6th Street, Suite 2410   SE DECISION MADE: 14-FEB-17
Minneapolis MN  55402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VitriGuard
ORIGIO A/S                        510(k) NO: K162833(Traditional)
ATTN: ROAIDA  JOHNSON             PHONE NO : 45 4 6790200 
KNARDRUPVEJ 2                     SE DECISION MADE: 16-FEB-17
MALOV  DK 2760                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System
LUMENIS LTD                       510(k) NO: K162837(Traditional)
ATTN: NAAMA  JACOBY               PHONE NO : 972 495 99085 
6 HAKIDMA STREET PO BOX 240 YOKNEASE DECISION MADE: 28-FEB-17
YOKNEAM  IL 2069204               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5
Roche Diagnostics                 510(k) NO: K162840(Traditional)
ATTN: Linda  McCammack            PHONE NO : 317 5217144 
9115 Hague Road                   SE DECISION MADE: 08-FEB-17
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VariAx Distal Radius Plating System, VariAx 2 System
Stryker GmbH                      510(k) NO: K162841(Traditional)
ATTN: Irene  Bacalocostantis      PHONE NO : 201 8316797 
325 Corporate Drive               SE DECISION MADE: 21-FEB-17
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Huvex Interspinous Fixation System
DIO MEDICAL CO., LTD.             510(k) NO: K162849(Traditional)
ATTN: LEE  SUNG-HEE               PHONE NO : 82 31 7763690 
101-105 MEGACENTER, SK TECHNOPARK SE DECISION MADE: 16-FEB-17
JUNGWON-GU SUNGNAM-SI  KR 462-850 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove
Lucenxia Prescience AG            510(k) NO: K162852(Traditional)
ATTN: Robert  Hill                PHONE NO : 41 417 689126 
Rathausstrasse  7                 SE DECISION MADE: 08-FEB-17
Baar  CH 6341                     510(k) STATEMENT
                                                    

DEVICE: Reveal LINQ
Medtronic, Inc.                   510(k) NO: K162855(Traditional)
ATTN: Syed Sumran Mohiuddin       PHONE NO : 763 5262380 
8200 Coral Sea Street NE          SE DECISION MADE: 23-FEB-17
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MCS Bone Graft
BIOVENTUS LLC                     510(k) NO: K162860(Traditional)
ATTN: John  Brunelle              PHONE NO : 949 5531717 
4721 EMPEROR BLVD SUITE 100       SE DECISION MADE: 13-FEB-17
DURHAM NC  27703                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sentry IVC filter
NOVATE MEDICAL LTD.               510(k) NO: K162875(Traditional)
ATTN: GORDON  CROWLEY             PHONE NO : 353 91 750030 
BLOCK 11, GALWAY TECHNOLOGY PARK, SE DECISION MADE: 17-FEB-17
GALWAY  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cercon
Dentsply Sirona                   510(k) NO: K162888(Traditional)
ATTN: Karl  Nittinger             PHONE NO : 717 8494424 
221 West Philadelphia Street SuiteSE DECISION MADE: 24-FEB-17
York PA  17404                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
Exactech Inc                      510(k) NO: K162903(Special)
ATTN: Thomas  McNamara            PHONE NO : 352 377 1140
2320 NW 66th Court                SE DECISION MADE: 27-FEB-17
Gainesville FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sofia RSV FIA on Sofia 2 analyzer
Quidel Corporation                510(k) NO: K162911(Traditional)
ATTN: Edward C. Brehm             PHONE NO : 858 5521100 21015
12544 High Bluff Drive, Suite 200 SE DECISION MADE: 22-FEB-17
San Diego, CA  92130              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fully Automatic Electronic Blood Pressure Monitor
Andon Health Co., Ltd.            510(k) NO: K162915(Abbreviated)
ATTN: Liu  Yi                     PHONE NO : 86 22 60526161 9060
No. 3 Jin Ping Street, Ya An Road,SE DECISION MADE: 08-FEB-17
Tianjin  CN 300190                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3NT endoscopy system
3NT Medical Ltd.                  510(k) NO: K162916(Traditional)
ATTN: Ehud  Bendory               PHONE NO : 972 73 7154056 
22 Hamelacha street PO Box 11384  SE DECISION MADE: 24-FEB-17
Rosh Ha’ayin  IL 4809169          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atlas Spine Expandable Interbody System
Atlas Spine, Inc.                 510(k) NO: K162918(Traditional)
ATTN: Thomas  Smith               PHONE NO : 561 7411108 
1555 Jupiter Park Drive, Suite 1  SE DECISION MADE: 09-FEB-17
Jupiter FL  33458                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GalaFORM 3D
TEPHA, INC.                       510(k) NO: K162922(Traditional)
ATTN: CONNIE H GARRISON           PHONE NO : 781 3571709 
99 HAYDEN AVENUE                  SE DECISION MADE: 23-FEB-17
LEXINGTON MA  02421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE
HARTALEGA NGC SDN. BHD.           510(k) NO: K162923(Traditional)
ATTN: KUAN MUN LEONG              PHONE NO : 603 6 2771733 
KAWASAN PERINDUSTRIAN TANJUNG     SE DECISION MADE: 06-FEB-17
SEPANG  MY 43900                  510(k) STATEMENT
                                                    

DEVICE: Air-Powered Handpieces and Handpiece Attachments
W&H DENTALWERK BURMOOS GMBH       510(k) NO: K162926(Traditional)
ATTN: Anja  Lindner               PHONE NO : 43 6274 6236397 
IGNAZ-GLASER-STRABE 53            SE DECISION MADE: 23-FEB-17
Bürmoos  AT 5111                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker
Stryker Corporation               510(k) NO: K162929(Traditional)
ATTN: Brittney M. Larsen          PHONE NO : 1 269 3895293 
Botzinger Strasse 41              SE DECISION MADE: 22-FEB-17
Freiburg Baden-Wurttemberg  DE D-7510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker OrthoMap Versatile Hip System
Stryker Corporation               510(k) NO: K162937(Traditional)
ATTN: Brittney  Larsen            PHONE NO : 269 3895293 
4100 E. Milham Ave.               SE DECISION MADE: 23-FEB-17
Kalamazoo MI  49001               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge
Medtronic, Inc.                   510(k) NO: K162958(Traditional)
ATTN: Harsh  Dharamshi            PHONE NO : 763 5058646 
7611 Northland Drive North        SE DECISION MADE: 01-FEB-17
Minneapolis MN  55428             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction
TEI Biosciences Inc.              510(k) NO: K162965(Traditional)
ATTN: Kavita  Amin                PHONE NO : 617 2681616 
7 Elkins Street                   SE DECISION MADE: 16-FEB-17
Boston MA  02127                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoWrist Suction Irrigator
Intuitive Surgical, Inc.          510(k) NO: K162973(Traditional)
ATTN: Melissa S. Gonzalez         PHONE NO : 408 5232100 
1266 Kifer Road                   SE DECISION MADE: 06-FEB-17
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
Medline Industries, Inc.          510(k) NO: K162982(Traditional)
ATTN: Jennifer  Mason             PHONE NO : 847 6433652 
One Medline Place                 SE DECISION MADE: 27-FEB-17
Mundelein IL  60060               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FA100 SCCD (Sequential Continuous Contraction Device)
FlowAid Medical Technologies, Corp510(k) NO: K162987(Traditional)
ATTN: Jacob  Brezel               PHONE NO : 212 4613225 
44 Wall Street                    SE DECISION MADE: 14-FEB-17
New York NY  10005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rusch Simplastic Foley Catheters
TELEFLEX MEDICAL, INC.            510(k) NO: K162989(Traditional)
ATTN: LORI  PFOHL                 PHONE NO : 919 4918960 
3015 CARRINGTON MILLS BLVD        SE DECISION MADE: 24-FEB-17
MORRISVILLE NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CareLink SmartSync Device Manager - Pacing System Analyzer
Medtronic, Inc.                   510(k) NO: K163008(Traditional)
ATTN: Laura  Danielson            PHONE NO : 763 5262385 
8200 Coral Sea Street NE          SE DECISION MADE: 28-FEB-17
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kyphon Xpede Bone Cement
Medtronic Inc.                    510(k) NO: K163032(Traditional)
ATTN: Pamela  Edwards             PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 27-FEB-17
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intra medullary endo-transilluminating device (iMET device)
WEMED BIO-TECH INC.               510(k) NO: K163037(Traditional)
ATTN: YIN-JIUN  TSENG             PHONE NO : 886 228 819573 
RM. D, 7F., NO.96, HOUGANG ST., SHSE DECISION MADE: 17-FEB-17
Taipei City  TW 111               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EPIC Extremity Snap-Off Screw
EPIC EXTREMITY, LLC               510(k) NO: K163038(Traditional)
ATTN: DAN  SCHWARTZBAUER          PHONE NO : 412 9560320 
120 MARGUERITE DR, STE 301        SE DECISION MADE: 28-FEB-17
CRANBERRY TWP PA  16066           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E
PT. MEDISAFE TECHNOLOGIES         510(k) NO: K163041(Traditional)
ATTN: DEEPAK  BANG                PHONE NO : 62 61 30007134 
JI. BATANG KUIS, GG TAMBAK REJO PASE DECISION MADE: 22-FEB-17
TANJUNG MORAWA, MEDAN  ID 20362   510(k) STATEMENT
                                                    

DEVICE: Omron HEM-6400T-Z Wrist Blood Pressure Monitor
Omron Healthcare, Inc.            510(k) NO: K163045(Traditional)
ATTN: Renee  Thornborough         PHONE NO : 847 2475626 
1925 West Field Court             SE DECISION MADE: 21-FEB-17
Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long
DEPUY SYNTHES                     510(k) NO: K163046(Traditional)
ATTN: JOANNA  RIEDER              PHONE NO : 41 327 204117 
1301 GOSHEN PARKWAY               SE DECISION MADE: 09-FEB-17
WEST CHESTER PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearLumen II Peripheral Thrombectomy System
Walk Vascular, LLC                510(k) NO: K163051(Traditional)
ATTN: David  Look                 PHONE NO : 949 7529642 
17171 Daimler Street              SE DECISION MADE: 21-FEB-17
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Revolution™ Spinal Fixation System
Intelligent Implant Systems, LLC  510(k) NO: K163056(Traditional)
ATTN: Michael  Nutt               PHONE NO : 704 4241009 
3300 International Airport Drive, SE DECISION MADE: 24-FEB-17
Charlotte NC  28208               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Altus Spine Cervical Plate System
Altus Partners, LLC               510(k) NO: K163061(Traditional)
ATTN: Claudia  Hill               PHONE NO : 610 3554156 
1340 Enterprise Drive             SE DECISION MADE: 06-FEB-17
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST-GN Tobramycin (/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (/=16 ug/mL)
bioMerieux, Inc.                  510(k) NO: K163083(Traditional)
ATTN: Mary Beth Anheuser          PHONE NO : 314 7318518 
595 Anglum Road                   SE DECISION MADE: 01-FEB-17
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack
Focus Diagnostics, Inc.: DBA DiaSo510(k) NO: K163085(Traditional)
ATTN: Irene M. Guzman             PHONE NO : 562 2406133 
11331 Valley View Street          SE DECISION MADE: 14-FEB-17
Cypress CA  90630                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VibraPEP
Medica Holdings, LLC              510(k) NO: K163091(Traditional)
ATTN: George  Reed                PHONE NO : 503 2235360 
5200 Meadows Road Suite 150       SE DECISION MADE: 21-FEB-17
Lake Osego OR  97035              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lyme B. burgdorferi (IgG) MarStripe Test
Trinity Biotech                   510(k) NO: K163095(Traditional)
ATTN: Kevin  Lawson               PHONE NO : 716 6910091 
60 Pineview Dr.                   SE DECISION MADE: 01-FEB-17
Buffalo NY  14031                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Q-Switched Nd:YAG Laser Therapy Systems
BEIJING SINCOHEREN SCIENCE AND TEC510(k) NO: K163123(Traditional)
ATTN: HUAN  KONG                  PHONE NO : 086 010 57734969 
ROOM 305, NO.43, XIZHIMEN NORTH STSE DECISION MADE: 02-FEB-17
BEIJING  CN 100044                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)
Blue Sail Medical Co., Ltd        510(k) NO: K163126(Traditional)
ATTN: Robin  Liu                  PHONE NO : 86 533 7871217 
No. 21 Qingtian Road Qilu ChemicalSE DECISION MADE: 22-FEB-17
Zibo  CN 255414                   510(k) STATEMENT
                                                    

DEVICE: POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs
HEBEI HONGSEN PLASTICS TECHNOLOGY 510(k) NO: K163146(Traditional)
ATTN: Shaozhang  Nan              PHONE NO : 86 319 7295820 
ESTERN INDUSTRIAL ZONE            SE DECISION MADE: 13-FEB-17
NANGONG  CN 051800                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MTM Clear Aligner
DENTSPLY SIRONA                   510(k) NO: K163155(Traditional)
ATTN: HELEN  LEWIS                PHONE NO : 717 4871332 
221 WEST PHILADELPHIA STREET SUITESE DECISION MADE: 03-FEB-17
York PA  17408                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AM-100
BTL INDUSTRIES, INC               510(k) NO: K163165(Traditional)
ATTN: David  Chmel                PHONE NO : 866 2851656 
47 Loring Drive                   SE DECISION MADE: 16-FEB-17
Framington MA  01702              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)
HEBEI HONGTAI PLASTIC PRODUCTS COM510(k) NO: K163168(Traditional)
ATTN: Liu  Wei                    PHONE NO : 86 319 436237 
NO. 15, LUBAN ROAD, JULU COUNTY   SE DECISION MADE: 23-FEB-17
XINGTAI  CN 055250                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent
COOK IRELAND LTD                  510(k) NO: K163169(Traditional)
ATTN: Charlene  Ryan              PHONE NO : 011 353 61334440 2428
O HALLORAN ROAD NATIONAL TECHNOLOGSE DECISION MADE: 07-FEB-17
LIMERICK  IE                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Handheld Diode Laser for Hair Removal
Liaoning Sidey Optoelectronics Tec510(k) NO: K163173(Traditional)
ATTN: Li  Zhao                    PHONE NO : 86 10 56370050 
No.6 Building,No.262 Yueling Rd. HSE DECISION MADE: 08-FEB-17
AnShan  CN 114044                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cobas PCR media Dual Swab Sample Kit
Roche Molecular Systems, Inc.     510(k) NO: K163184(Traditional)
ATTN: David W. Gates              PHONE NO : 925 7308237 
4300 Hacienda Drive               SE DECISION MADE: 09-FEB-17
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ComfortGuard Surgical Gown, i600, Film Reinforced
GRI MEDICAL & ELECTRICAL TECHNOLOG510(k) NO: K163191(Traditional)
ATTN: Martin D. Paugh             PHONE NO : 86 135 11359722 
1805 HONGGAO ROAD, XIUZHOU INDUSTRSE DECISION MADE: 27-FEB-17
JIAXING  CN 314031                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unicare System, Unicare Manipulator
ClearPath Surgical, Inc.          510(k) NO: K163214(Traditional)
ATTN: Puja  Ohlhaver              PHONE NO : 888 9797467 700
1052 High Street                  SE DECISION MADE: 07-FEB-17
Palo Alto CA  94301               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GORE BIO-A Tissue Reinforcement
W. L. GORE & ASSOCIATES, INC.     510(k) NO: K163217(Traditional)
ATTN: Barbara L Smith             PHONE NO : 410 5068189 
301 Airport Rd. PO BOX 1408       SE DECISION MADE: 10-FEB-17
Elkton MD  21922-1408             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biograph mMR with syngo MR E11P system software
Siemens Medical Solutions USA, Inc510(k) NO: K163234(Traditional)
ATTN: Cordell L. Fields           PHONE NO : 610 4486469 
65 Valley Stream Parkway          SE DECISION MADE: 28-FEB-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Virtual Occupational Therapy Application (VOTA)
Barron Associates, Inc.           510(k) NO: K163245(Traditional)
ATTN: Bruce G. Wilson             PHONE NO : 434 9731215 
1410 Sachem Place Suite 202       SE DECISION MADE: 28-FEB-17
Charlottesville VA  22901         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeptiCyte LAB
IMMUNEXPRESS, INC.                510(k) NO: K163260(Traditional)
ATTN: VICTORIA  ROTHWELL          PHONE NO : 206 8586436 
425 PONTIUS AVE. NORTH            SE DECISION MADE: 17-FEB-17
SEATTLE WA  98109                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlexCath Select Steerable Shealth and Dilator
Medtronic CryoCath LP             510(k) NO: K163268(Traditional)
ATTN: Natalie  Sadeghi            PHONE NO : 763 526 1035
8200 Coral Sea Street NE, Mail StoSE DECISION MADE: 02-FEB-17
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AXIOS Stent and Electrocautery Enhanced Delivery System
Boston Scientific Corporation     510(k) NO: K163272(Traditional)
ATTN: Kayla  Mackey               PHONE NO : 508 6834534 
100 Boston Scientific Way         SE DECISION MADE: 18-FEB-17
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRU Legionella
MERIDIAN BIOSCIENCE, INC.         510(k) NO: K163273(Special)
ATTN: Lauren  Davis               PHONE NO : 513 2713700 
3471 RIVER HILLS DRIVE            SE DECISION MADE: 21-FEB-17
CINCINNATI OH  45244              510(k) STATEMENT
                                                    

DEVICE: Medtronic Transportation/Sterilization Cassettes
Medtronic Sofamor Danek, USA, Inc.510(k) NO: K163279(Traditional)
ATTN: Julie  Bassett              PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 23-FEB-17
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Apex Dental Sensors
Masterlink LLC                    510(k) NO: K163282(Traditional)
ATTN: Tom  Birney                 PHONE NO : 1 800 8690915 
24654 N. Lake Pleasant Parkway SuiSE DECISION MADE: 28-FEB-17
Peoria AZ  85383                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo Application Software
SIEMENS MEDICAL SOLUTION USA, INC.510(k) NO: K163285(Traditional)
ATTN: PATRICIA D. JONES           PHONE NO : 610 4486474 
40 LIBERTY BOULEVARD 65-1A        SE DECISION MADE: 14-FEB-17
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo. CT Single Source Dual Energy (twin beam)
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K163289(Traditional)
ATTN: Kimberly  Mangum            PHONE NO : 610 4486477 
40 Liberty Blvd.. Mail Code 65-1A SE DECISION MADE: 09-FEB-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K163294(Traditional)
ATTN: CORDELL L. FIELDS           PHONE NO : 610 4486469 
40 LIBERTY BLVD MAIL CODE 65-1A   SE DECISION MADE: 06-FEB-17
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL
Liofilchem s. r. l.               510(k) NO: K163298(Traditional)
ATTN: Fabio  Brocco               PHONE NO : 39 085 8930745 
Via Scozia zona ind.le            SE DECISION MADE: 22-FEB-17
Roseto degli Abruzzi  IT 64026    510(k) STATEMENT
                                                    

DEVICE: ELECTROmatic
Kaltenbach & Voigt GmgH           510(k) NO: K163317(Traditional)
ATTN: Stefan  Trampler            PHONE NO : 49 7351 563515 
Bismarckring 39                   SE DECISION MADE: 21-FEB-17
Biberach  DE 88400                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TZ SKULL PIN Adult
TZ MEDICAL INC                    510(k) NO: K163322(Traditional)
ATTN: JOHN  LUBISICH              PHONE NO : 503 639 0282
17750 SW UPPER BOONES FERRY RD #15SE DECISION MADE: 23-FEB-17
PORTLAND OR  97224                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.CT Extended Functionality
SIEMENS MEDICAL SOLUTIONS USA, Inc510(k) NO: K163341(Traditional)
ATTN: Kimberly  Mangum            PHONE NO : 610 4486477 
 40 Liberty Blvd., Mail Code 65-1ASE DECISION MADE: 09-FEB-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALLY™ Facet Screws
PROVIDENCE MEDICAL TECHNOLOGY, INC510(k) NO: K163374(Traditional)
ATTN: MARGARET  WONG              PHONE NO : 415 9239376 
1331 N. CALIFORNIA BLVD. SUITE 320SE DECISION MADE: 16-FEB-17
WALNUT CREEK CA  94596            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Serranator Alto PTA Serration Balloon Catheter
Cagent Vascular, LLC              510(k) NO: K163380(Traditional)
ATTN: Carol  Burns                PHONE NO : 610 6882006 
150 Strafford Avenue #315         SE DECISION MADE: 13-FEB-17
Wayne PA  19087                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Astroglide Diamond Silicone Gel Personal Lubricant
BioFilm, Inc.                     510(k) NO: K163395(Traditional)
ATTN: Richard  Hines              PHONE NO : 760 7279030 
3225 Executive Ridge              SE DECISION MADE: 10-FEB-17
Vista CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fiagon Navigation – PointerTube Straight and PointerTube Keat
FIAGON GMBH                       510(k) NO: K163416(Special)
ATTN: DIRK  MUCHA                 PHONE NO : 49 330 22012110 
                                  SE DECISION MADE: 16-FEB-17
HENNIGSDORF  DE 16761             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HA Minuteman G3-R MIS Fusion Plate
Spinal Simplicity                 510(k) NO: K163428(Special)
ATTN: Douglas B Snell             PHONE NO : 913 4514414 
10995 Quivira Road                SE DECISION MADE: 02-FEB-17
Overland Park KS  66210           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stealth Staple System
FIRST RAY LLC                     510(k) NO: K163440(Traditional)
ATTN: ROBERT  HOY                 PHONE NO : 614 4486358 
124 SOUTH 600 WEST, SUITE 100     SE DECISION MADE: 01-FEB-17
LOGAN UT  84321                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PICC Maximal Barrier Nursing Kit
Navilyst Medical, Inc.            510(k) NO: K163452(Special)
ATTN: Robin  Fuller               PHONE NO : 508 6587986 
26 Forest Street                  SE DECISION MADE: 03-FEB-17
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reveal LINQ Insertable Cardiac Monitor
MEDTRONIC,INC.                    510(k) NO: K163460(Traditional)
ATTN: Laura  Danielson            PHONE NO : 763 5262385 
8200 CORAL SEA ST NE              SE DECISION MADE: 14-FEB-17
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcuNav Volume ICE Catheter
Siemens Medical Solutions USA, Inc510(k) NO: K163478(Special)
ATTN: Shelly  Pearce              PHONE NO : 650 2790134 
685 East Middlefield Road         SE DECISION MADE: 09-FEB-17
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Renamel NANO +plus
Cosmedent, Inc                    510(k) NO: K163480(Traditional)
ATTN: Hiren  Patel                PHONE NO : 312 6449586 
401 N Michigan Ave, Suite 2500    SE DECISION MADE: 24-FEB-17
Chicago IL  60611                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultima HA Coated Half Pins and Wire
Vilex in Tennessee, Inc           510(k) NO: K163487(Traditional)
ATTN: Sylvia  Southard            PHONE NO : 931 4747550 
111 Moffitt Street                SE DECISION MADE: 13-FEB-17
McMinnville TN  37110             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PIVO
Velano Vascular                   510(k) NO: K163508(Special)
ATTN: Tiffini  Diage              PHONE NO : 617 6426460 
1756 Fillmore St.                 SE DECISION MADE: 09-FEB-17
San Francisco CA  94115           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NovaGuard SA Pro Safety System
WEST PHARMACEUTICAL SERVICES, INC.510(k) NO: K163511(Special)
ATTN: Ana  Ladino                 PHONE NO : 610 5943165 
530 HERMAN O. WEST DRIVE          SE DECISION MADE: 02-FEB-17
EXTON PA  19341-1147              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arrow Endurance Extended Dwell Peripheral Catheter System
Arrow International, Inc. (subsidi510(k) NO: K163513(Special)
ATTN: Fallon  Young               PHONE NO : 610 9847188 
2400 Bernville Road               SE DECISION MADE: 24-FEB-17
Reading PA  19605                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: my Patch sl
DMS-SERVICE LLC                   510(k) NO: K163535(Special)
ATTN: LYNDA  COLE                 PHONE NO : 
11845 W OLYMPIC BLVD STE 880W     SE DECISION MADE: 22-FEB-17
LOS ANGELES CA  90064             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biomet Fusion System
Zimmer Biomet Spine Inc.          510(k) NO: K163543(Special)
ATTN: Megan  Fessenden            PHONE NO : 303 4658994 
310 Interlocken Parkway Suite 120 SE DECISION MADE: 28-FEB-17
Broomfield CO  80021              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENSEAL X1 Large Jaw Tissue Sealer
Ethicon Endo-Surgery, LLC         510(k) NO: K163548(Traditional)
ATTN: Marjorie  Medina            PHONE NO : 787 6534603 
475 Calle C                       SE DECISION MADE: 14-FEB-17
Guaynabo PR  00969                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClotTriever Thrombectomy System
Inari Medical, Inc.               510(k) NO: K163549(Third Party - Traditional)
ATTN: Eben  Gordon                PHONE NO : 949 6008433 114
9272 Jeronimo Road Suite 124      SE DECISION MADE: 16-FEB-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: LenSx Laser System
Alcon Laboratories, Inc.          510(k) NO: K163551(Traditional)
ATTN: James  Arganda              PHONE NO : 949 5057038 
20511 Lake Forest Dr              SE DECISION MADE: 03-FEB-17
Lake Forest CA  92630             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hubble I System
Orbbo Surgical, LLC.              510(k) NO: K163566(Traditional)
ATTN: Eric  Garofano              PHONE NO : 800 9421880 
555 W. 5th Street, 35th           SE DECISION MADE: 09-FEB-17
Los Angeles CA  90013             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD PosiFlush Heparin Lock Flush Syringe
Becton Dickinson and Company      510(k) NO: K163591(Special)
ATTN: Aakash  Jain                PHONE NO : 201 8475879 
1 Becton Drive                    SE DECISION MADE: 27-FEB-17
Franklin Lakes NJ  07045          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOGIQ P9 and LOGIQ P7
GE HEALTHCARE                     510(k) NO: K163596(Traditional)
ATTN: BRYAN  BEHN                 PHONE NO : 414 7214214 
9900 INNOVATION DR.               SE DECISION MADE: 10-FEB-17
WAUWATOSA WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kepler I Cervical Plate System
Orbbo Surgical, LLC.              510(k) NO: K163602(Traditional)
ATTN: Eric  Garofano              PHONE NO : 800 9421880 
555 W. 5th Street, 35th           SE DECISION MADE: 16-FEB-17
Los Angeles CA  90013             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIGNA PET/MR
GE Medical Systems, LLC           510(k) NO: K163619(Traditional)
ATTN: Janice M. Sich              PHONE NO : 262 5216312 
3200 N. Grandview Blvd.           SE DECISION MADE: 14-FEB-17
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ExpressBraid Graft Manipulation
Biomet Manufacturing Corp.        510(k) NO: K163651(Traditional)
ATTN: Vinay  Bhal                 PHONE NO : 574 3713028 
56 East Bell Drive PO Box 587     SE DECISION MADE: 17-FEB-17
Warsaw IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10
MEDISONO, LLC                     510(k) NO: K163688(Abbreviated)
ATTN: JORGE  MILLAN               PHONE NO : 786 4165587 
3511 SILVERSIDE RD STE 105        SE DECISION MADE: 23-FEB-17
WILMINGTON DE  19810              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HS70A Diagnostic Ultrasound System
Samsung Medison Co., Ltd.         510(k) NO: K163691(Third Party - Traditional)
ATTN: Emily  Woo                  PHONE NO : 82 2 21947120 
42, Teheran-ro 108-gil Gangnam-gu SE DECISION MADE: 22-FEB-17
Seoul  KR 06176                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VIVIX-S 1417N
VIEWORKS CO., LTD.                510(k) NO: K163703(Traditional)
ATTN: JORDIN  KIM                 PHONE NO : 82 70 11961859 
(GWANYANG-DONG) 41-3, BURIM-RO 170SE DECISION MADE: 08-FEB-17
ANYANG-SI  KR 431-060             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FIRMap Catheter
ABBOTT ELECTROPHYSIOLOGY          510(k) NO: K163709(Traditional)
ATTN: DENNIS  POZZO               PHONE NO : 314 3006580 
1530 OBRIEN DRIVE SUITE B         SE DECISION MADE: 28-FEB-17
MENLO PARK CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
COOK INCORPORATED                 510(k) NO: K170008(Traditional)
ATTN: ERUM B. NASIR               PHONE NO : 812 3353575 102607
750 DANIELS WAY                   SE DECISION MADE: 28-FEB-17
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aquilion Lightning, TSX-036A/1, V8.4
Toshiba Medical Systems Corporatio510(k) NO: K170019(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 02-FEB-17
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProMIS™ Fixation System
Premia Spine Ltd.                 510(k) NO: K170061(Special)
ATTN: Kobi  Arbus                 PHONE NO : 972 72 22811200 
7 Giborey Israel Street           SE DECISION MADE: 02-FEB-17
Netanya  IL 4250407               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fitmore® Hip Stem
Zimmer GmbH                       510(k) NO: K170072(Special)
ATTN: Thomas  Lincoln             PHONE NO : 41 58 8548257 
Sulzerallee 8                     SE DECISION MADE: 07-FEB-17
Winterthur  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pinnacle Radiation Therapy Planning System
Philips Medical Systems (Cleveland510(k) NO: K170086(Special)
ATTN: Michelle  Godin             PHONE NO : 774 3317499 
5520 Nobel Drive                  SE DECISION MADE: 09-FEB-17
Fitchburg WI  53711               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UA-Cellular Complete
Streck                            510(k) NO: K170091(Traditional)
ATTN: Deborah  Kipp               PHONE NO : 402 5375215 
7002 S. 109th Street              SE DECISION MADE: 09-FEB-17
La Vista NE  68128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Laparoscope Lens Shield Device (LENS)
Medeon Biodesign, Inc             510(k) NO: K170103(Special)
ATTN: Greta  Chang                PHONE NO : 886 2 28816686 
7F, 116, HouGang St,              SE DECISION MADE: 16-FEB-17
Taipei  TW 11170                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Jac-Cell Medic testers
JAC-CELL MEDIC                    510(k) NO: K170105(Traditional)
ATTN: MARK  MELTZER               PHONE NO : 1 800 7200931 
5764 Pare Street Tmr              SE DECISION MADE: 28-FEB-17
Mont - Royal  CA H4P 2M2          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: pixium 4343RCE
Philips Medical Systems DMC GmbH  510(k) NO: K170113(Special)
ATTN: Ming  Xiao                  PHONE NO : 49 40 50782306 
Roentgenstrasse 24-26             SE DECISION MADE: 09-FEB-17
Hamburg  DE 22335                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Abbott ARCHITECT Free T3
Abbott Laboratories               510(k) NO: K170160(Traditional)
ATTN: Linda  Sohn                 PHONE NO : 224 6674846 
100 Abbott Park Road, Dept 09AA, BSE DECISION MADE: 15-FEB-17
Abbott Park IL  60064             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Erisma® LP Spinal Fixation System
CLARIANCE SAS                     510(k) NO: K170163(Special)
ATTN: Pascal  ROKEGEM             PHONE NO : 33 3 21161215 
18 rue Robespierre                SE DECISION MADE: 14-FEB-17
BEAURAINS  FR 62217               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Valleylab FT10 Electrosurgical Platform
Covidien llc                      510(k) NO: K170170(Special)
ATTN: Sharon  McDermott           PHONE NO : 303 5816789 
5920 Longbow Drive                SE DECISION MADE: 16-FEB-17
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advance 14LP Low Profile PTA Balloon Dilatation Catheter
COOK INCORPORATED                 510(k) NO: K170193(Special)
ATTN: DANIEL J. CORBIN            PHONE NO : 812 3353575 104018
750 DANIELS WAY                   SE DECISION MADE: 13-FEB-17
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aquarius 8600
IMAGING DYNAMICS COMPANY LTD.     510(k) NO: K170202(Special)
ATTN: Nicole  Wherry              PHONE NO : 403 2519939 
130, 3510 29th St. NE             SE DECISION MADE: 22-FEB-17
Calgary  CA T1Y 7E5               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImPACT
IMPACT APPLICATIONS, INC          510(k) NO: K170209(Special)
ATTN: MICHAEL  ZAGORSKI           PHONE NO : 412 5678400 
9665 GRANITE RIDGE DRIVE SUITE 550SE DECISION MADE: 23-FEB-17
SAN DIEGO CA  92123               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vesco Medical NRFit Tip Syringes
Vesco Medical, LLC                510(k) NO: K170218(Third Party - Traditional)
ATTN: Chris  O'Keefe              PHONE NO : 614 9145991 
692 N. High Street, Suite 205     SE DECISION MADE: 24-FEB-17
Columbus OH  43215                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Truliant Femoral Components
Exactech Inc                      510(k) NO: K170240(Special)
ATTN: Patrick  Hughes             PHONE NO : 352 3274762 
2320 NW 66th CT                   SE DECISION MADE: 23-FEB-17
Gainesville FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sydney IVF Culture Oil
William A. Cook Australia Pty Ltd 510(k) NO: K170257(Special)
ATTN: Gordana  Pozvek             PHONE NO : 61 7 38411188 
95 Brandl Street                  SE DECISION MADE: 24-FEB-17
Eight Mile Plains  AU 4113        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpeedLyser Infusion Catheter
AngioDynamics, Inc.               510(k) NO: K170258(Special)
ATTN: Teri  Juckett               PHONE NO : 518 7951142 
603 Queensbury Avenue             SE DECISION MADE: 21-FEB-17
Queensbury NY  12804              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GRAVITYTM PEEK-OPTIMA Suture Anchor
Wright Medical Technology, Inc.   510(k) NO: K170265(Special)
ATTN: Tara  Conrad                PHONE NO : 901 8674367 
1023 Cherry Road                  SE DECISION MADE: 23-FEB-17
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Nexiva Diffusics Closed IV Catheter System
Becton, Dickinson and Company     510(k) NO: K170283(Third Party - Traditional)
ATTN: Amy  Honey                  PHONE NO : 801 5652300 
9450 South State Street           SE DECISION MADE: 28-FEB-17
Sandy UT  84070                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 3M Protemp Cement Temporary Dental Cement
3M Company                        510(k) NO: K170330(Third Party - Traditional)
ATTN: Gretchen  Keenan            PHONE NO : 651 7337605 
2510 Conway Avenue                SE DECISION MADE: 06-FEB-17
St. Paul MN  55144-1000           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Flextra Steerable Introducer
Rhythm Xience, Inc. (RXI)         510(k) NO: K170373(Third Party - Traditional)
ATTN: James  Hassett              PHONE NO : 952 4797903 
10025 Valley View Road, Suite 130 SE DECISION MADE: 27-FEB-17
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW


                   TOTAL 510(k)s THIS PERIOD   243                                     
                   TOTAL WITH SUMMARIES        235                                     
                   TOTAL WITH STATEMENTS         8