Medical Devices

July 2017 510(k) Clearances

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


DEVICE: Fujifilm Duodenoscope Model ED-530XT
FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K152257(Traditional)
ATTN: AARON  GE                   PHONE NO : 973 6862636 
10 HIGH POINT DRIVE               SE DECISION MADE: 21-JUL-17
WAYNE NJ  07470                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns
BAM CORPORATION LIMITED           510(k) NO: K160337(Traditional)
ATTN: MARY  MEJAES                PHONE NO : 852 36955272 
NO. 138 SHATIN RURAL COMMITTEE ROASE DECISION MADE: 07-JUL-17
HONG KONG  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITROS Chemistry Products hsCRP Reagent
Ortho Clinical Diagnostics        510(k) NO: K160712(Traditional)
ATTN: Marlene  Hanna              PHONE NO : 585 4534041 
100 Indigo Creek Drive            SE DECISION MADE: 14-JUL-17
Rochester NY  14626               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Everyway Incontinence Stimulation System
EVERYWAY MEDICAL INSTRUMENT CO., L510(k) NO: K161349(Traditional)
ATTN: ROBERT  TU                  PHONE NO : 886 226 620038 
3FL., NO. 5, LANE 155, SECTION 3, SE DECISION MADE: 07-JUL-17
SHENKENG DIST, NEW TAIPEI CITY  CN510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
Sportarredo Group S.C.            510(k) NO: K161394(Traditional)
ATTN: STEFANO  IRIDIO             PHONE NO : 0039 0421 767676 
Via dell' Industria 7             SE DECISION MADE: 06-JUL-17
Gruaro  IT 30020                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Teco Creatinine Enzymatic Reagent Kit
TECO DIAGNOSTICS, INC.            510(k) NO: K161527(Traditional)
ATTN: XIAOYAN  HU                 PHONE NO : 714 4631111 
1268 NORTH LAKEVIEW AVENUE        SE DECISION MADE: 21-JUL-17
ANAHEIM CA  92807                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Blood Pressure Monitor
Shenzhen Pango Electronic Co.,Ltd.510(k) NO: K161845(Special)
ATTN: Xiaoyun  Yang               PHONE NO : 86 755 33825988 
No.25, 1st Industrial Park, FenghuSE DECISION MADE: 31-JUL-17
Shenzhen  CN 518115               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System
ASCENSION ORTHOPEDICS             510(k) NO: K162153(Traditional)
ATTN: GABRIELLA  BECKER           PHONE NO : 609 9363625 
8700 CAMERON ROAD, SUITE 100      SE DECISION MADE: 14-JUL-17
AUSTIN TX  78754                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)
VILLA SISTEMI MEDICALI S.P.A.     510(k) NO: K162190(Abbreviated)
ATTN: PAOLO CASAGRANDE SANTIN     PHONE NO : 39 024 8859239 
VIA DELLE AZALEE 3                SE DECISION MADE: 06-JUL-17
BUCCINASCO  IT I-20090            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CADD® Infusion Disposables Portfolio with NRFit™ connectors
Smiths Medical ASD, Inc.          510(k) NO: K162219(Traditional)
ATTN: Wendy J. Kivens             PHONE NO : 1 800 4335832 
6000 Nathan Lane North            SE DECISION MADE: 20-JUL-17
Minneapolis MN  55442             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color
SHEN WEI USA INC.                 510(k) NO: K162312(Traditional)
ATTN: CHERYL  BAILEY-KROLL        PHONE NO : 510 4298692 
33278 CENTRAL AVE STE 102         SE DECISION MADE: 25-JUL-17
UNION CITY CA  94587              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CO2 Laser Therapy Systems
BEIJING SINCOHEREN SCIENCE AND TEC510(k) NO: K162398(Traditional)
ATTN: XIN  WANG                   PHONE NO : 086 010 57734966 
ROOM 305, NO.43, XIZHIMEN NORTH STSE DECISION MADE: 06-JUL-17
BEIJING  CN 100044                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RT300 FES cycle ergometer
Restorative Therapies, Inc.       510(k) NO: K162470(Traditional)
ATTN: Andrew  Barriskill          PHONE NO : 800 6099166 304
1434 Fleet St.                    SE DECISION MADE: 11-JUL-17
Baltimore MD  21231               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
UG GLOBAL RESOURCES SDN. BHD.     510(k) NO: K162510(Traditional)
ATTN: WONG SEE KEONG              PHONE NO : 6006  6772751 
1ST FLOOR NO.18, JALAN DATO ABD RASE DECISION MADE: 18-JUL-17
SEREMBAN  MY 70000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearPath Aligner
ClearPath Orthodontics Ltd        510(k) NO: K162609(Traditional)
ATTN: Waqas  Wahab                PHONE NO : 92 42 111333276 
6-N, Main Boulevard               SE DECISION MADE: 06-JUL-17
Johar Town  PK                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Custom Bars
IMPLANT DIRECT SYBRON MANUFACTURIN510(k) NO: K162633(Traditional)
ATTN: Reina  Choi                 PHONE NO : 
3050 EAST HILLCREST DRIVE         SE DECISION MADE: 24-JUL-17
THOUSAND OAKS CA  91362           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer
SHENZHEN NEW INDUSTRIES BIOMEDICAL510(k) NO: K162698(Traditional)
ATTN: Jie  Rao                    PHONE NO : 86 755 21536601 
NO.16, JINHUI RD, PINGSHAN NEW DISSE DECISION MADE: 14-JUL-17
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Circular Stapler, Single Use Hemorrhoidal 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
Golden Stapler Surgical Co., Ltd. 510(k) NO: K162707(Traditional)
ATTN: Hao  Chao                   PHONE NO : 86 519 85070751 
Building 7A,Jiangsu Wujin Sci-TechSE DECISION MADE: 14-JUL-17
Changzhou  CN 213164              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Portable Slit Lamp Microscope
SUZHOU KANGJIE MEDICAL INC        510(k) NO: K162778(Traditional)
ATTN: Hong  Zhu                   PHONE NO : 086 512 67067065 
No. 129, Weixin Rd., Weiting Town SE DECISION MADE: 21-JUL-17
Suzhou  CN 215000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts
VASCUTEK LTD.                     510(k) NO: K162803(Traditional)
ATTN: NEIL  MCLACHLAN             PHONE NO : 44 141 8125555 
NEWMAINS AVE,                     SE DECISION MADE: 14-JUL-17
INCHINNAN  GB PA4 9RR             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SterilContainer S System
AESCULAP, INC                     510(k) NO: K162815(Traditional)
ATTN: Paul  Amudala               PHONE NO : 800 2581946 
3773 CORPORATE PKWY               SE DECISION MADE: 13-JUL-17
CENTER VALLEY PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SML-OSA2 Appliances
SELANE PRODUCTS, INC.             510(k) NO: K162816(Traditional)
ATTN: JOHN  CHRISTIAN             PHONE NO : 800 4233270 
9129 LURLINE AVENUE               SE DECISION MADE: 27-JUL-17
CHATSWORTH CA  91311              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bonafix TWO - Dental Implant System
BONAFIX SURGICAL AND DENTAL IMPLAN510(k) NO: K162853(Traditional)
ATTN: Juan  Tezak                 PHONE NO : 561 7892411 
118 W PRIVE CIR                   SE DECISION MADE: 14-JUL-17
DELRAY BEACH FL  33445            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)
Bonart Co., Ltd.                  510(k) NO: K162856(Abbreviated)
ATTN: Bankson  Tsai               PHONE NO : 886 22298 3980 
NO. 80, WUXUAN ST.,               SE DECISION MADE: 18-JUL-17
KEELUNG CITY  TW 20446            510(k) STATEMENT
                                                    

DEVICE: NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST
Careplus (M) SDN BHD              510(k) NO: K162858(Traditional)
ATTN: LIM KWEE SHYAN              PHONE NO : 60 6 6772781 
Lot 120 & 121, Jalan Senawang 3, SSE DECISION MADE: 24-JUL-17
SEREMBAN  MY 70450                510(k) STATEMENT
                                                    

DEVICE: MagDen Dental Implant System
SHINHUNG MST Co., Ltd.            510(k) NO: K162867(Traditional)
ATTN: Lee  Sunbyung               PHONE NO : 82 33 7301900 
110-2, Donghwagongdan-ro Munmak-euSE DECISION MADE: 26-JUL-17
Wonju-si  KR 220-801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kitazato ET Catheters
Kitazato Corporation              510(k) NO: K162878(Traditional)
ATTN: Mari  Yazaki                PHONE NO : 81 3 58006055 
1-1-8 Shibadaimon, Minato-ku      SE DECISION MADE: 13-JUL-17
Tokyo  JP 105-0012                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kitazato OPU Needles
Kitazato Corporation              510(k) NO: K162881(Traditional)
ATTN: Mari  YAZAKI                PHONE NO : 81 3 58006055 
1-1-8 Shibadaimon, Minato-ku      SE DECISION MADE: 11-JUL-17
Tokyo  JP 105-0012                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biodesign Parastomal Hernia Repair Graft
Cook Biotech Incorporated         510(k) NO: K162934(Traditional)
ATTN: Perry W. Guinn              PHONE NO : 765 497 3355
1425 Innovation Place             SE DECISION MADE: 10-JUL-17
West Lafayette IN  47906          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK MS
bioMerieux, Inc.                  510(k) NO: K162950(Traditional)
ATTN: Nathan  Hardesty            PHONE NO : 314 7318666 
595 Anglum Rd.                    SE DECISION MADE: 22-JUL-17
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TUBETECH IV Administration Set
Douglas Medical Products, Inc.    510(k) NO: K162951(Traditional)
ATTN: Doug  Johnson               PHONE NO : 847 9094298 
345 Dunbar Road                   SE DECISION MADE: 28-JUL-17
Mundelein IL  60060               510(k) STATEMENT
                                                    

DEVICE: U2 Femoral Head
UNITED ORTHOPEDIC CORPORATION     510(k) NO: K162957(Traditional)
ATTN: GIMPEL  CHIEN               PHONE NO : 886 3 5773351 2217
NO 57, PARK AVE 2, SCIENCE PARK   SE DECISION MADE: 17-JUL-17
HSINCHU  TW 300                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: YELLOW 560 Fluorescence Module
Carl Zeiss Meditec AG             510(k) NO: K162991(Traditional)
ATTN: Peter  Schrutka-RechtenstammPHONE NO : 49 7364 203943 
Goeschwitzer Str. 51-52           SE DECISION MADE: 24-JUL-17
Jena  DE 07745                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Karl Storz UROMAT E.A.S.I.
KARL STORZ ENDOSCOPY AMERICA, INC 510(k) NO: K162992(Traditional)
ATTN: SERKAN  SEZER               PHONE NO : 424 2188201 
2151 E. GRAND AVENUE              SE DECISION MADE: 07-JUL-17
EL SEGUNDO CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TIGR Matrix Surgical Mesh
NOVUS SCIENTIFIC AB               510(k) NO: K163005(Traditional)
ATTN: MATS  NORBERG               PHONE NO : 46 187 001150 
VIRDINGS ALLE                     SE DECISION MADE: 27-JUL-17
UPPSALA  SE 754 50                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DORA Disposable A.V. Fistula Needle Sets
Bain Medical Equipment (Guangzhou)510(k) NO: K163025(Traditional)
ATTN: Sophia  Shao                PHONE NO : 86 20 66856868 
No.10 Juncheng Road Eastern Zone oSE DECISION MADE: 20-JUL-17
Guangzhou  CN 510760              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bunegin-Albin Air Aspiration Set
COOK INCORPORATED                 510(k) NO: K163031(Traditional)
ATTN: JOHNATHAN  LIU              PHONE NO : 812 3353575 104509
750 DANIELS WAY                   SE DECISION MADE: 27-JUL-17
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DilaCheck Nitrile Powder Free Examination Glove, (Sterile)
Elm Tree Medical, Inc.            510(k) NO: K163035(Traditional)
ATTN: Eva  Martin                 PHONE NO : 215 8050862 
1543 Sloat Blvd. #320725          SE DECISION MADE: 07-JUL-17
San Francisco CA  94132           510(k) STATEMENT
                                                    

DEVICE: Smart Stitching Software System, Image Processing, Radiological
OSKO, INC.                        510(k) NO: K163048(Traditional)
ATTN: Richard  Jeon               PHONE NO : 1 305 5997161 
8085 NW 90TH ST                   SE DECISION MADE: 28-JUL-17
MEDLEY FL  33166                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Relizorb
Alcresta Therapeutics, Inc.       510(k) NO: K163057(Traditional)
ATTN: Robert  Gallotto            PHONE NO : 617 4313600 
One Newton Executive Park Suite 10SE DECISION MADE: 12-JUL-17
Newton MA  02462                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PHMB Antimicrobial Foam Wound Dressing
Advanced Medical Solutions Ltd.   510(k) NO: K163062(Traditional)
ATTN: Kay  McGrath                PHONE NO : 44 1606 863500 
Premier Park, 33 Road One, WinsforSE DECISION MADE: 25-JUL-17
Winsford  GB CW7 3RT              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Demi Ultra
KERR CORPORATION                  510(k) NO: K163064(Special)
ATTN: Mohammad Saad Ansari        PHONE NO : 714 5167334 
1717 W. COLLINS AVE               SE DECISION MADE: 18-JUL-17
ORANGE CA  92867                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: bellavista 1000
IMTMEDICAL AG                     510(k) NO: K163127(Traditional)
ATTN: BEAT  KELLER                PHONE NO : 41 81 7506699 
GEWERBESTRASSE 8                  SE DECISION MADE: 31-JUL-17
BUCHS SG  CH CH-9470              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Youha electric breast pump
NINGBO YOUHE ELECTRICAL APPLIANCE 510(k) NO: K163136(Traditional)
ATTN: Huang Yun Jun               PHONE NO : 86 574 63860315 
NO.226-228, SAN JIAO TIAN RD, FU HSE DECISION MADE: 31-JUL-17
CIXI  CN 315322                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NIRA Beauty Skin Laser
Dermal Photonics Corporation      510(k) NO: K163137(Traditional)
ATTN: David  Bean                 PHONE NO : 781 4511700 
5 Elm St, Suite 10                SE DECISION MADE: 12-JUL-17
Danvers MA  01923                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ViMove2
DORSAVI LTD                       510(k) NO: K163150(Special)
ATTN: DAN  RONCHI                 PHONE NO : 61 03 96522191 
LEVEL 1, 120 JOLIMONT RD          SE DECISION MADE: 14-JUL-17
EAST MELBOURNE  AU 3002           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dario Blood Glucose Monitoring System
LabStyle Innovations, Ltd.        510(k) NO: K163159(Traditional)
ATTN: Erez  Raphael               PHONE NO : 972 52 5522685 
9 Halamish Street, North IndustriaSE DECISION MADE: 19-JUL-17
Caesarea  IL 3890000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA
IMMCO DIAGNOSTICS, INC.           510(k) NO: K163177(Traditional)
ATTN: KEVIN  LAWSON               PHONE NO : 716 4915452 
9870 Hollingson Rd                SE DECISION MADE: 28-JUL-17
Clarence NY  14031                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neodent Implant System - GM Line
JJGC INDUSTRIA E COMERCIO DE MATER510(k) NO: K163194(Traditional)
ATTN: Julianne  Lechechem         PHONE NO : 55 41 21694058 
AV. JUSCELINO KUBITSCHEK DE OLIVEISE DECISION MADE: 14-JUL-17
CURITIBA  BR 81270-200            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitrea View
Vital Images, Inc                 510(k) NO: K163232(Traditional)
ATTN: Fei  Li                     PHONE NO : 952 4879539 
5850 Opus Parkway Suite 300       SE DECISION MADE: 21-JUL-17
Minnetonka MN  55343              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AXS Offset Delivery Assist Catheter
STRYKER NEUROVASCULAR             510(k) NO: K163259(Traditional)
ATTN: Shazia  Hakim               PHONE NO : 510 4132636 
47900 Bayside Parkway             SE DECISION MADE: 28-JUL-17
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infant Transport Mattress Warmer with Disc
RAPID AID CORP.                   510(k) NO: K163295(Traditional)
ATTN: Laureta  Prifti             PHONE NO : 001 905 8204788 
4120 A SLADEVIEW CRESENT          SE DECISION MADE: 24-JUL-17
MISSISSAUGA  CA L5L 5Z3           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Soules Intrauterine Insemination Catheter
Cook Incorporated                 510(k) NO: K163318(Traditional)
ATTN: Naomi N. Funkhouser         PHONE NO : 812 3392235 104371
750 Daniels Way                   SE DECISION MADE: 14-JUL-17
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wheelchair
Kunshan Hi-Fortune Health Products510(k) NO: K163352(Traditional)
ATTN: HongFa  Zhi                 PHONE NO : 86 512 55195100 
No. 301, Qinhe Road, Zhangpu Town SE DECISION MADE: 28-JUL-17
KunShan  CN 215300                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Needle's Eye Snare Retrieval Set - 54cm
Cook Incorporated                 510(k) NO: K163353(Special)
ATTN: Thomas  Kardos              PHONE NO : 724 8458621 2225
750 Daniels Way, P.O. Box 489     SE DECISION MADE: 11-JUL-17
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XPress BCD Breast Compression Device
XPress BCD, LLC                   510(k) NO: K163388(Traditional)
ATTN: Peter  Kremers              PHONE NO : 301 4015853 
6024 White Flint Drive            SE DECISION MADE: 19-JUL-17
Frederick MD  21702               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Orbit Inserter
YPSOMED AG                        510(k) NO: K163400(Traditional)
ATTN: STEPHAN  AFFOLTER           PHONE NO : 41 344 243382 
BRUNNMATTSTRASSE 6                SE DECISION MADE: 26-JUL-17
BURGDORF  CH CH-3401              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
ACON LABORATORIES INC.            510(k) NO: K163406(Traditional)
ATTN: QIYI  XIE                   PHONE NO : 858 8758011 
10125 MESA RIM ROAD               SE DECISION MADE: 11-JUL-17
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates
HNM Total Recon, LLC              510(k) NO: K163486(Traditional)
ATTN: Noah  Roitman               PHONE NO : 866 2918498 
20855 NE 16th Ave Suite C15       SE DECISION MADE: 24-JUL-17
Miami FL  33179                   510(k) STATEMENT
                                                    

DEVICE: Borrelia B31 ViraChip IgG Test Kit
VIRAMED BIOTECH AG                510(k) NO: K163504(Traditional)
ATTN: MARTIN  KINTRUP+            PHONE NO : 49 898 99336 
BEHRINGSTRASSE 11                 SE DECISION MADE: 12-JUL-17
PLANEGG  DE 82152                 510(k) STATEMENT
                                                    

DEVICE: MALDI Biotyper CA (MBT-CA) System, MBT smart CA System
BRUKER DALTONIK GMBH              510(k) NO: K163536(Traditional)
ATTN: MARKUS  KOSTRZEWA           PHONE NO : 49 042 122051258 
FAHRENHEITSTRASSE 4               SE DECISION MADE: 26-JUL-17
BREMEN  DE 28359                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed AcuNav Diagnostic Ultrasound Catheter
Innovative Health, LLC.           510(k) NO: K163560(Traditional)
ATTN: Rafal  Chudzik              PHONE NO : 480 5256006 
1435 North Hayden Road Suite 100  SE DECISION MADE: 12-JUL-17
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Great Basin Stool Bacterial Pathogens Panel
Great Basin Scientific, Inc.      510(k) NO: K163571(Traditional)
ATTN: Suzette  Chance             PHONE NO : 801 9901055 
2441 S. 3850 West                 SE DECISION MADE: 12-JUL-17
Salt Lake City UT  84120          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M3290B Philips IntelliVue Information Center iX
Philips Medical Systems           510(k) NO: K163584(Traditional)
ATTN: Theresa  Poole              PHONE NO : 978 6597621 
3000 Minuteman Road               SE DECISION MADE: 07-JUL-17
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIGN IM Nail
SIGN FRACTURE CARE INTERNATIONAL  510(k) NO: K163589(Traditional)
ATTN: Robert  Schmitt             PHONE NO : 509 3711107 
451 Hills Street, Suite B         SE DECISION MADE: 20-JUL-17
Richland WA  99354                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VacLok AT Vacuum Syringe
Merit Medical Systems, Inc.       510(k) NO: K163597(Abbreviated)
ATTN: Angela  Brady               PHONE NO : 801 3164818 
1600 West Merit Parkway           SE DECISION MADE: 27-JUL-17
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator
ADVANCED STERILIZATION PRODUCTS   510(k) NO: K163598(Traditional)
ATTN: NAZANIN  YACOBI             PHONE NO : 949 7898672 
33 TECHNOLOGY DR                  SE DECISION MADE: 31-JUL-17
IRVINE CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cobas HbA1c Test, cobas b 101 system
Roche Diagnostics Operations      510(k) NO: K163633(Traditional)
ATTN: Patty  Bates                PHONE NO : 317 5214572 
9115 Hague Road                   SE DECISION MADE: 28-JUL-17
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series
Grandway Technology (Shenzhen) Lim510(k) NO: K163648(Traditional)
ATTN: Patrick  Chow               PHONE NO : 852 285 16789 
Block 7, Zhu Keng Industrial Zone,SE DECISION MADE: 07-JUL-17
Shenzhen  CN 518118               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OLINDA EXM
Hermes Medical Solutions AB       510(k) NO: K163687(Traditional)
ATTN: Joakim  Arwidson            PHONE NO : 46 81 90325 
Skeppsbron 44                     SE DECISION MADE: 19-JUL-17
Stockholm  SE 11130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OSSIX BONE
Dantum Dental Ltd                 510(k) NO: K163714(Traditional)
ATTN: Arie  Goldlust              PHONE NO : 972 8 6705400 
1 Bat Sheva St., PO Box 6170      SE DECISION MADE: 18-JUL-17
Lod  IL 7116003                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Easyret
Quantel Medical                   510(k) NO: K170067(Traditional)
ATTN: Bruno  Pages                PHONE NO : 33 04 73745732 
11 rue Bois Joli, CS40015         SE DECISION MADE: 25-JUL-17
Cournon D'Auvergne-Cedex  FR 63808510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LightMed Dental Laser System
LIGHTMED DENTALTECHNOLOGY CORP.   510(k) NO: K170073(Traditional)
ATTN: APRIL  CHENG                PHONE NO : 886 7 6955111 
5F., NO. 96, LUKE 5TH RD., LUZHU DSE DECISION MADE: 25-JUL-17
KAOHSIUNG  TW 821                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RTHawk, HeartVista Cardiac Package
HeartVista, Inc.                  510(k) NO: K170090(Special)
ATTN: James J Rogers              PHONE NO : 650 8007937 
4984 El Camino Real, Suite 102    SE DECISION MADE: 14-JUL-17
Los Altos CA  94022               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CreoDent Solidex Customized Abutment and Screw
CreoDent Prosthetics, Ltd.        510(k) NO: K170100(Traditional)
ATTN: Calvin  Shim                PHONE NO : 212 3023860 
29 West 30th Street 11th Floor    SE DECISION MADE: 18-JUL-17
New York NY  10001                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,
Bionime Corporation               510(k) NO: K170143(Traditional)
ATTN: Kay  Wu                     PHONE NO : 886 4 23692388 
No. 100, Sec. 2, Daqing St., SouthSE DECISION MADE: 06-JUL-17
Taichung  TW 40242                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARDIOVIT FT-1
SCHILLER AG                       510(k) NO: K170182(Traditional)
ATTN: ZHENRONG  YU                PHONE NO : 41 417 664252 
ALTGASSE 68                       SE DECISION MADE: 19-JUL-17
BAAR  CH CH-6371                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Photodynamic Therapy Device
UVBIOTEK, LLC                     510(k) NO: K170187(Traditional)
ATTN: Dave  Oberhelman            PHONE NO : 518 7473310 
3 Depot Street                    SE DECISION MADE: 28-JUL-17
Hudson Falls NY  12839            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Obturys
Itena Clinical                    510(k) NO: K170207(Abbreviated)
ATTN: Charles  Peyre              PHONE NO : 33 145 913006 
83 Avenue Foch                    SE DECISION MADE: 31-JUL-17
Paris  FR 75116                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microlife Digital Infrared Ear Thermometer
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K170219(Traditional)
ATTN: GERHARD  FRICK              PHONE NO : 41 717 277059 
ESPENSTRASSE 139                  SE DECISION MADE: 20-JUL-17
WIDNAU  CH 9443                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Progreat
ASHITAKA FACTORY OF TERUMO CORPORA510(k) NO: K170223(Traditional)
ATTN: LAUREN P. NITAHARA          PHONE NO : 732 4124129 
150 MAIMAIGI-CHO                  SE DECISION MADE: 21-JUL-17
FUJINOMIYA  JP 418-0015           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spider Cervical Plating System
X-SPINE SYSTEMS, INC.             510(k) NO: K170224(Traditional)
ATTN: KRISS  ANDERSON             PHONE NO : 937 8478400 2137
452 ALEXANDERSVILLE RD.           SE DECISION MADE: 06-JUL-17
MIAMISBURG OH  45342              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Leica FL560
LEICA MICROSYSTEMS (SCHWEIZ) AG   510(k) NO: K170239(Traditional)
ATTN: GRAINNE  GRIFFIN            PHONE NO : 353 867 710135 
MAX SCHMIDHEINY-STRASSE 201       SE DECISION MADE: 05-JUL-17
HEERBRUGG  CH 9435                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spinal Manometer NRFit; Spinal Manometer LUER
PAJUNK GmbH Medizintechnologie    510(k) NO: K170305(Traditional)
ATTN: Christian G.H. Quass        PHONE NO : 49 7770 49291586 
Karl-Hall-Str. 1                  SE DECISION MADE: 25-JUL-17
Geisingen  DE 78187               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIX Ankle Distal Tibia System
Jeil Medical Corporation          510(k) NO: K170313(Traditional)
ATTN: Sejin  RYU                  PHONE NO : 82 2 8503500 
#702, Kolon Science Valley 2nd 55,SE DECISION MADE: 27-JUL-17
Seoul  KR 152-728                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeoFuse Ti3D PLIF/TLIF/Cervical Interbody
HT Medical, LLC                   510(k) NO: K170318(Traditional)
ATTN: Robert  Compton             PHONE NO : 918 9952090 
6316 E. 102nd Street              SE DECISION MADE: 12-JUL-17
Tulsa OK  74137                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: dynaMX Intramedullary Implant
Arthrex, Inc.                     510(k) NO: K170326(Traditional)
ATTN: Howard L. Schrayer          PHONE NO : 609 9249510 
1370 Creekside Boulevard          SE DECISION MADE: 20-JUL-17
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Standard Clamp
Standard Bariatrics               510(k) NO: K170379(Traditional)
ATTN: Alison  Sathe               PHONE NO : 513 3047971 
4362 Glendale Milford Rd.         SE DECISION MADE: 19-JUL-17
Cincinnati OH  45242              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANCHORMAN Tibial Ligament Fixation Device
Summit Medical Ltd.               510(k) NO: K170388(Traditional)
ATTN: Sam  Drew                   PHONE NO : 44 01451 821311 
Bourton Industrial Park           SE DECISION MADE: 25-JUL-17
Bourton on the Water  GB GL54 2HQ 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs
Kossan International Sdn. Bhd.    510(k) NO: K170397(Traditional)
ATTN: Cho Sow Fong                PHONE NO : 603 32910516 
Wisma Kossan, Lot 782, Jalan SungaSE DECISION MADE: 10-JUL-17
Klang  MY 42100                   510(k) STATEMENT
                                                    

DEVICE: Endoskeleton TO Interbody Fusion Device (IBD)
Titan Spine, LLC                  510(k) NO: K170399(Traditional)
ATTN: Jane  Rodd                  PHONE NO : 262 2427801 
6140 W. Executive Dr., Suite A    SE DECISION MADE: 06-JUL-17
Mequon WI  53092                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD ChloraShield IV Dressing with CHG Antimicrobial
Avery Dennison Belgie BVBA        510(k) NO: K170407(Traditional)
ATTN: Lisa  Bartakovics           PHONE NO : 1 312 2066159 
Tieblokkenlaan 1                  SE DECISION MADE: 17-JUL-17
Turnhout  BE b-2300               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Enterprise Imaging XERO Viewer 8.1
Agfa HealthCare N.V.              510(k) NO: K170434(Traditional)
ATTN: Jodi  Coleman               PHONE NO : 519 7466210 2485
Septestraat 27                    SE DECISION MADE: 03-JUL-17
Mortsel  BE b-2640                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NerveGuard NRFit, NerveGuard LUER
PAJUNK GmbH Medizintechnologie    510(k) NO: K170435(Traditional)
ATTN: Christian G.H. Quass        PHONE NO : 49 770 49291586 
Karl-Hall-Str. 1                  SE DECISION MADE: 12-JUL-17
Geisingen  DE 78187               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Models 3543A, 4343A, 2929A and A843B
Shanghai PZ Medical Technolgoy Co.510(k) NO: K170480(Traditional)
ATTN: Jeff  Moeller               PHONE NO : 847 3373004 
5F, Building 13 No.2 Suide Road   SE DECISION MADE: 07-JUL-17
Shanghai  CN 200331               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages
EIT Emerging Implant Technologies 510(k) NO: K170503(Traditional)
ATTN: Barbara  Wirth              PHONE NO : 49 7461 1716904 
Eisenbahnstrasse 84               SE DECISION MADE: 11-JUL-17
Wurmlingen  DE 78573              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx
Invacare Corporation              510(k) NO: K170507(Traditional)
ATTN: Elijah N. Wreh              PHONE NO : 440 3296840 
One Invacare Way                  SE DECISION MADE: 12-JUL-17
Elyria OH  44035                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: In2Bones Fracture and Correction System
In2BonesUSA, LLC                  510(k) NO: K170518(Traditional)
ATTN: Joe  Clift                  PHONE NO : 901 2607931 
6060 Poplar Ave, Suite 380        SE DECISION MADE: 14-JUL-17
Memphis TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: True Form Reshapable Guide Wire
Merit Medical Systems, Inc.       510(k) NO: K170532(Traditional)
ATTN: Mark  Mullaney              PHONE NO : 353 91 703700 3061
Parkmore Business Park West       SE DECISION MADE: 21-JUL-17
Galway  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anorganic Bone Mineral in Delivery Applicator
Collagen Matrix, Inc.             510(k) NO: K170541(Traditional)
ATTN: Danielle  Lindner           PHONE NO : 201 4051477 
15 Thornton Road                  SE DECISION MADE: 07-JUL-17
Oakland NJ  07436                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TOKUYAMA CUREGRACE
Tokuyama Dental Corporation       510(k) NO: K170549(Traditional)
ATTN: Fumio  Takahashi            PHONE NO : 81 3 38352261 
38-9 Taitou 1-chome, Taitou-ku    SE DECISION MADE: 05-JUL-17
Tokyo  JP 110-0016                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Coveris Cervical Cage System
Camber Spine Technologies         510(k) NO: K170550(Traditional)
ATTN: Ryan  Gaffney               PHONE NO : 484 4204286 112
418 E. Lancaster Avenue           SE DECISION MADE: 13-JUL-17
Wayne PA  19087                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Comply Hydrogen Peroxide Indicator Tape
3M Company                        510(k) NO: K170563(Traditional)
ATTN: Nadia  Battah               PHONE NO : 651 7330929 
3M Center, Building 275-5W-06     SE DECISION MADE: 27-JUL-17
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tempus Pro Patient Monitor
Remote Diagnostic Technologies Ltd510(k) NO: K170567(Traditional)
ATTN: Chris  Hannan               PHONE NO : 440 1256 362400 
Pavilion C2, Ashwood Park, AshwoodSE DECISION MADE: 06-JUL-17
Basingstoke  GB RG23 8BG          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis
ACON Laboratories, Inc.           510(k) NO: K170587(Traditional)
ATTN: Qiyi  Xie                   PHONE NO : 858 8758011 
10125 Mesa Rim Road               SE DECISION MADE: 06-JUL-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARTO 3 EP Navigation System, Version 6.0 and Accessories
Biosense Webster, Inc.            510(k) NO: K170600(Traditional)
ATTN: Phoung  Chau                PHONE NO : 909 8398500 
33 Technology Drive               SE DECISION MADE: 25-JUL-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: !M1
Solutions For Tomorrow AB         510(k) NO: K170607(Traditional)
ATTN: Martin  Yngvesson           PHONE NO : 46 10 4564500 
Saxagardsv. 4                     SE DECISION MADE: 17-JUL-17
Vackelsang  SE 36251              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Genius Total Knee System
Signature Orthopaedics Pty Ltd.   510(k) NO: K170613(Traditional)
ATTN: Declan  Brazil              PHONE NO : 61 2 94285181 
7 Sirius Road                     SE DECISION MADE: 17-JUL-17
Lane Cove  AU 2066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: sensiFirm
EL Global Trade Ltd               510(k) NO: K170637(Traditional)
ATTN: Yael  Liebes                PHONE NO : 972 9 7889067 
8 Tzoran St, P.O. Box 8242        SE DECISION MADE: 14-JUL-17
Netanya  IL 4250608               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula
CooperSurgical, Inc.              510(k) NO: K170660(Traditional)
ATTN: Roaida  Johnson             PHONE NO : 1 203 6015200 3325
95 Corporate Drive                SE DECISION MADE: 13-JUL-17
Trumbull CT  06611                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Graftgun Universal Graft Delivery System
Surgentec, LLC                    510(k) NO: K170675(Traditional)
ATTN: Travis  Greenhalgh          PHONE NO : 916 7597999 
7601 N Federal Highway # 150B     SE DECISION MADE: 19-JUL-17
Boca Raton FL  33487              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HD Lumbar Interbody System
HD LifeSciences LLC               510(k) NO: K170676(Traditional)
ATTN: Ian  Helmar                 PHONE NO : 978 5956625 
38 Montvale Ave Ste 380           SE DECISION MADE: 13-JUL-17
Stoneham MA  02180                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs
Brightway Holdings Sdn. Bhd.      510(k) NO: K170686(Traditional)
ATTN: G.  Baskaran                PHONE NO : 603 33431007 
Lot 1559, Jalan Istimewa, Batu BelSE DECISION MADE: 14-JUL-17
Klang  MY 42100                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Equashield Closed System drug Transfer Device (CSTD)
Equashield Medical Ltd.           510(k) NO: K170706(Traditional)
ATTN: Dorit  Valal                PHONE NO : 972 4 9873737 
tefen industrial park             SE DECISION MADE: 03-JUL-17
migdal tefen  IL 24959            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: True Spinal Fixation System
Innovative Surgical Designs, Inc. 510(k) NO: K170710(Traditional)
ATTN: Jon  Rinehart               PHONE NO : 217 8368522 
3903 S. Walnut St.                SE DECISION MADE: 14-JUL-17
Bloomington IN  47401             510(k) STATEMENT
                                                    

DEVICE: Examion X-AQS
Examion GmbH                      510(k) NO: K170729(Traditional)
ATTN: Andreas  Oppermann          PHONE NO : 49 711 120002263 
Erich-Herion Strassa 37           SE DECISION MADE: 18-JUL-17
Fellbach  DE 70736                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aegis Transit System
Boston-Biomedical Associates      510(k) NO: K170757(Traditional)
ATTN: Lauren  Baker               PHONE NO : 508 3518632 245
100 Crowley Drive, Suite 216      SE DECISION MADE: 14-JUL-17
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mini Needle
OcuJect, LLC                      510(k) NO: K170768(Traditional)
ATTN: Rebecca K. Pine             PHONE NO : 760 8095178 
1441 Avocado Ave., Suite 204      SE DECISION MADE: 10-JUL-17
Newport Beach CA  92660           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: wireless thermometer
ECH (Changzhou) Medical Instrument510(k) NO: K170769(Traditional)
ATTN: Yuan  Hu                    PHONE NO : 86 519 88161606 
No.65, Huiling West Rd. Zouqu TownSE DECISION MADE: 26-JUL-17
Changzhou  CN 213144              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CT Midline
Medical Components, Inc. (dba Medc510(k) NO: K170770(Special)
ATTN: Courtney  Nix               PHONE NO : 215 2564201 
1499 Delp Drive                   SE DECISION MADE: 25-JUL-17
Harleysville PA  19438            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mini Stick ENVI Non-Vascular Introducer Kit
AngioDynamics, Inc.               510(k) NO: K170775(Traditional)
ATTN: Hans  Kjolhede              PHONE NO : 508 6587944 
26 Forest Street                  SE DECISION MADE: 19-JUL-17
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Faxitron Bioptics Speciemen Radiography System
Faxitron Bioptics LLC             510(k) NO: K170786(Traditional)
ATTN: Douglas C. Wiegman          PHONE NO : 520 3998180 
3440 E. Britannia Dr. Suite 150   SE DECISION MADE: 18-JUL-17
Tucson AZ  85706                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dictum Health
Dictum Health, Inc.               510(k) NO: K170798(Abbreviated)
ATTN: Paul  Landesman             PHONE NO : 510 2954450 
255 3rd Avenue Suite 102          SE DECISION MADE: 14-JUL-17
Oakland CA  94607                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unity Total Knee System
Corin USA Limited                 510(k) NO: K170808(Traditional)
ATTN: Rachel  King                PHONE NO : 813 9774469 
5670 W Cypress Street, Suite C    SE DECISION MADE: 13-JUL-17
Tampa FL  33607                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HygePLUS Alginate Impression Material
HYGEDENT INC.                     510(k) NO: K170812(Traditional)
ATTN: Peng  Wang                  PHONE NO : 010 1 3901284956 
Daliushu Industrial Zone XiaotangsSE DECISION MADE: 26-JUL-17
Beijing  CN 102211                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Devon 24
Devon Medical Products (Jiangsu) L510(k) NO: K170814(Traditional)
ATTN: Julian  Chu                 PHONE NO : 86 513 51080988 
East Half of 1-2f, Appt D2, 1, QinSE DECISION MADE: 11-JUL-17
Nantong  CN 226017                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PSA Cable
Boston Scientific Corporation     510(k) NO: K170815(Traditional)
ATTN: Melissa  Klamerus           PHONE NO : 651 5826771 
4100 Hamline Ave North            SE DECISION MADE: 06-JUL-17
St. Paul MN  55112                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultimax-i, DREX-UI80 V1.60
Toshiba Medical Systems Corporatio510(k) NO: K170832(Traditional)
ATTN: Paul  Biggins               PHONE NO : 1 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 21-JUL-17
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BiopSee, Mobile US
MedCom GmbH                       510(k) NO: K170841(Traditional)
ATTN: Johannes  Messow            PHONE NO : 49 6151 95147258 
Dolivostrasse 11                  SE DECISION MADE: 26-JUL-17
Darmstadt  DE 64293               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WEGO-PTFE
Foosin Medical Supplies Inc., Ltd.510(k) NO: K170842(Traditional)
ATTN: Zhipeng  Yang               PHONE NO : 86 631 5660576 
No.20, Xingshan Road, Weihai TorchSE DECISION MADE: 31-JUL-17
Weihai  CN 264210                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gemini-C Hybrid Cervical Interbody System
Osseus Fusion Systems, LLC        510(k) NO: K170844(Traditional)
ATTN: Robert  Pace                PHONE NO : 214 3950100 
2703 Mockingbird Lane, Suite 102  SE DECISION MADE: 03-JUL-17
Dallas TX  75235                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: POD Packing Coil
Penumbra, Inc.                    510(k) NO: K170852(Traditional)
ATTN: Aditi  Kolla                PHONE NO : 510 9952010 
One Penumbra Place                SE DECISION MADE: 19-JUL-17
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FTRD System Set
Ovesco Endoscopy AG               510(k) NO: K170867(Traditional)
ATTN: Marc O. Schurr              PHONE NO : 49 707 198979121 
Dorfackerstrasse 26               SE DECISION MADE: 25-JUL-17
Tuebingen  DE 72074               510(k) STATEMENT
                                                    

DEVICE: Site~Rite Halcyon Diagnostic Ultrasound System
CHISON Medical Imaging Co., Ltd.  510(k) NO: K170870(Traditional)
ATTN: Qifei  Liu                  PHONE NO : 86 510 85311707 
NO.228, ChangJiang East Road,BlockSE DECISION MADE: 06-JUL-17
Wuxi  CN 214142                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DigniCap Scalp Cooling System
Dignitana AB                      510(k) NO: K170871(Traditional)
ATTN: Johan  Ericsson             PHONE NO : 46 46 163092 
Traktorgranden 3                  SE DECISION MADE: 03-JUL-17
Lund  SE se-226 60                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JAWS(TM) Nitinol Staple System
Paragon 28                        510(k) NO: K170923(Traditional)
ATTN: Frank S. Bono               PHONE NO : 888 7281888 
4B Inverness Ct. E., STE 280      SE DECISION MADE: 24-JUL-17
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RX NC Takeru PTCA Balloon Dilatation Catheter
Kaneka Corporation                510(k) NO: K170941(Traditional)
ATTN: Toshihiko  Motomine         PHONE NO : 81 3 55748023 
1-12-32, Akasaka, Minako-ku       SE DECISION MADE: 07-JUL-17
Tokyo  JP 107-6028                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
Surgical Instrument Service and Sa510(k) NO: K170955(Traditional)
ATTN: Brandi  Panteleon           PHONE NO : 541 9233310 
1500 NE Hemlock                   SE DECISION MADE: 03-JUL-17
Redmond OR  97756                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Eclipse Treatment Planning System
Varian Medical Systems, Inc.      510(k) NO: K170969(Traditional)
ATTN: Peter J. Coronado           PHONE NO : 1 650 4246320 
911 Hansen Way                    SE DECISION MADE: 05-JUL-17
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK
Becton, Dickinson and Company     510(k) NO: K170974(Traditional)
ATTN: Li  Zhou                    PHONE NO : 408 9542099 
2350 Qume Dr.                     SE DECISION MADE: 03-JUL-17
San Jose CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Embrace Neonatal MRI System
Aspect Imaging Ltd.               510(k) NO: K170978(Traditional)
ATTN: Israel  Citron              PHONE NO : 972 732 239000 
27 Shaked St.                     SE DECISION MADE: 19-JUL-17
Industrial Area Hevel Modi’in.  IL510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KATANA Zirconia Block
Kuraray Noritake Dental Inc.      510(k) NO: K170986(Traditional)
ATTN: Yasujiro  Ohara             PHONE NO : 81 3 67011736 
Ote Center Bldg. 7F               SE DECISION MADE: 13-JUL-17
Chiyoda-ku  JP 100-0004           510(k) STATEMENT
                                                    

DEVICE: CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
Biosense Webster, Inc.            510(k) NO: K170997(Traditional)
ATTN: John  Jimenez               PHONE NO : 1 949 9234774 
33 Technology Drive               SE DECISION MADE: 25-JUL-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: P50 Series Digital Color Doppler Ultrasound System
SONOSCAPE MEDICAL CORP.           510(k) NO: K170999(Traditional)
ATTN: Toki  Wu                    PHONE NO : 86 755 26722890 
4/f, 5/f, 8/f, 9/f & 10/f, Yizhe BSE DECISION MADE: 12-JUL-17
Shenzhen  CN 518051               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: P60 Series Digital Color Doppler Ultrasound System
SONOSCAPE MEDICAL CORP.           510(k) NO: K171000(Traditional)
ATTN: Toki  Wu                    PHONE NO : 86 755 26722890 
4/F, 5/F, 8/F, 9/F & 10/F, Yizhe BSE DECISION MADE: 11-JUL-17
Shenzhen  CN 518051               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader
3M Company                        510(k) NO: K171003(Traditional)
ATTN: Hilary B. Hovde             PHONE NO : 651 7360364 
3M Center, Building 275-5W-06     SE DECISION MADE: 21-JUL-17
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Axis Charcot Fixation System, 4.5 to 8.5mm Screw System
Extremity Medical, LLC.           510(k) NO: K171018(Traditional)
ATTN: Brian  Smekal               PHONE NO : 973 5888980 
300 Interpace Parkway Suite 410   SE DECISION MADE: 13-JUL-17
Parsippany NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JO Agapé Personal Lubricant
United Consortium                 510(k) NO: K171021(Traditional)
ATTN: Stephanie  Morris           PHONE NO : 661 2951700 
29000 N. Hancock Pkwy             SE DECISION MADE: 18-JUL-17
Valencia CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: eCareCoordinator
Visicu Inc.                       510(k) NO: K171029(Traditional)
ATTN: Daniel R. Plonski           PHONE NO : 410 2465357 
217 East Redwood St. Suite 1900   SE DECISION MADE: 14-JUL-17
Baltimore MD  21202               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CRESCENT™ Spinal System
Medtronic Sofamor Danek           510(k) NO: K171031(Special)
ATTN: Ankit K. Shah               PHONE NO : 901 3441272 
1800 Pyramid Pl.                  SE DECISION MADE: 06-JUL-17
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K171034(Traditional)
ATTN: Ma  Chao                    PHONE NO : 86 755 81886573 
Keji 12th Road South Hi-tech IndusSE DECISION MADE: 10-JUL-17
Shenzhen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range
Koelis                            510(k) NO: K171040(Traditional)
ATTN: Laetitia  GERVAIS           PHONE NO : 33 458 176810 
16, chemin du vieux chene         SE DECISION MADE: 31-JUL-17
MEYLAN  FR 38240                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeaSpine Cambria System
SeaSpine Orthopedics Corporation  510(k) NO: K171046(Traditional)
ATTN: Gina  Flores                PHONE NO : 760 2165136 
5770 Armada Drive                 SE DECISION MADE: 07-JUL-17
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biomet Knee Joint Replacement Prostheses
Biomet, Inc                       510(k) NO: K171054(Traditional)
ATTN: Jason  Heckaman             PHONE NO : 574 3718313 
56 East Bell Drive                SE DECISION MADE: 28-JUL-17
Warsaw IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Philips BlueControl
Philips Electronics Nederland B.V.510(k) NO: K171055(Traditional)
ATTN: Gaozhen  Hang               PHONE NO : 302 3587026 
High Tech Campus 5                SE DECISION MADE: 06-JUL-17
Eindhoven  NL 5656 AE             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZELTIQ CoolSculpting System
ZELTIQ Aesthetics, Inc.           510(k) NO: K171069(Traditional)
ATTN: Shruti  Jayakumar           PHONE NO : 925 4742516 
4410 Rosewood Road                SE DECISION MADE: 07-JUL-17
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRI-COMBO PARASITE SCREEN
Techlab, Inc.                     510(k) NO: K171078(Traditional)
ATTN: Donna T. Link               PHONE NO : 540 9531664 
2001 Kraft Drive                  SE DECISION MADE: 10-JUL-17
Blacksburg VA  24060-6358         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AXON IR Heat Lamp
Crystal Medtech, LLC              510(k) NO: K171087(Traditional)
ATTN: Nelson  Marquina            PHONE NO : 804 3663110 
4704 Bayberry Street              SE DECISION MADE: 07-JUL-17
Schofield WI  54476               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XiniWave II Model ECS322P
International Trade Group, Inc.   510(k) NO: K171092(Traditional)
ATTN: Brent C. Reider             PHONE NO : 614 5687000 
4663 Katie Lane                   SE DECISION MADE: 10-JUL-17
Oxford OH  45056                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE
Sanrea Healthcare Products Pvt Ltd510(k) NO: K171093(Traditional)
ATTN: JOSE PAUL M.                PHONE NO : 91 491 2970145 
Plot #P-56, Pearl Road Kinfra IIT SE DECISION MADE: 19-JUL-17
Palakkad  IN 678 621              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumipulse G TSH-III Immunoreaction Cartridges
Fujirebio Diagnostics, Inc.       510(k) NO: K171103(Traditional)
ATTN: Stacey  Dolan               PHONE NO : 610 2403917 
201 Great Valley Parkway          SE DECISION MADE: 28-JUL-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems
Supersonic Imagine                510(k) NO: K171105(Traditional)
ATTN: Laurence  HERMITTE          PHONE NO : 33 442 992424 
Les Jardins de la Duranne - Bat E&SE DECISION MADE: 11-JUL-17
Aix-en-Provence  FR 13857         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3D Endo Software
Dentsply Sirona                   510(k) NO: K171115(Traditional)
ATTN: Karl  Nittinger             PHONE NO : 717 8494424 
221 West Philadelphia Street, SuitSE DECISION MADE: 17-JUL-17
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIGNA Premier
GE Medical Systems, LLC           510(k) NO: K171128(Traditional)
ATTN: Mary A. Mayka               PHONE NO : 262 5273148 
3200 Grandview Blvd               SE DECISION MADE: 14-JUL-17
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carefusion NeutraClear Needle-free connector
CAIR LGL                          510(k) NO: K171132(Special)
ATTN: Delphine  Molinari          PHONE NO : 003 347 8437744 
1 allee des chevreuils - BOIS DIEUSE DECISION MADE: 31-JUL-17
LISSIEU  FR 69380                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories
Qfix                              510(k) NO: K171133(Traditional)
ATTN: Alexandra Nicole Low        PHONE NO : 610 2680585 
440 Church Road                   SE DECISION MADE: 11-JUL-17
Avondale PA  19311                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Altrix Temperature Management Wraps
Stryker Medical                   510(k) NO: K171149(Traditional)
ATTN: Brian  Orwat                PHONE NO : 269 3292100 
3800 East Centre Avenue           SE DECISION MADE: 18-JUL-17
Portage MI  49002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alma LipoFlow System
Alma Lasers Inc.                  510(k) NO: K171242(Traditional)
ATTN: Rekha  Anand                PHONE NO : 224 3772000 2019
485 Half Day Rd, Suite # 100      SE DECISION MADE: 14-JUL-17
Buffalo Grove IL  60089           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Monteris Medical NeuroBlate System
Monteris Medical, Inc.            510(k) NO: K171255(Traditional)
ATTN: David H. Mueller            PHONE NO : 763 2534710 
14755 27th Avenue North; Suite C  SE DECISION MADE: 25-JUL-17
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Otowave 302 Portable Tympanometer
Amplivox Ltd                      510(k) NO: K171265(Traditional)
ATTN: Chris  Roerig               PHONE NO : 44 01865 880846 
6 Oasis Park                      SE DECISION MADE: 28-JUL-17
Eynsham  GB OX29 4tp              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NavLock Trackers
Medtronic Navigation              510(k) NO: K171267(Traditional)
ATTN: Nicole  Zimmerman           PHONE NO : 720 8902342 
826 Coal Creek Circle             SE DECISION MADE: 03-JUL-17
Louisville CO  80027              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fully  Automatic Blood  Pressure  Monitor
Andon Health Co., Ltd             510(k) NO: K171282(Abbreviated)
ATTN: Liu  Yi                     PHONE NO : 86 22 87611660 9060
No. 3 Jin Ping Street, Ya An Road,SE DECISION MADE: 27-JUL-17
Tianjin  CN 300190                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIX Diaphysis System
Jeil Medical Corporation          510(k) NO: K171285(Traditional)
ATTN: Yein  Han                   PHONE NO : 82 850 3934 
#702, Kolon Science Valley 2nd 55,SE DECISION MADE: 24-JUL-17
Seoul  KR 152-728                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vela RX PTA Balloon Dilatation Catheter
Curatia Medical                   510(k) NO: K171290(Traditional)
ATTN: Jessica  Chiu               PHONE NO : 408 4142188 
3227 Kifer Road                   SE DECISION MADE: 19-JUL-17
Santa Clara CA  95051             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Scanmate Flex
DGH Technology, Inc.              510(k) NO: K171301(Third Party - Traditional)
ATTN: David  Henderson            PHONE NO : 610 5949100 
110 Summit Drive, Suite B         SE DECISION MADE: 31-JUL-17
Exton PA  19341                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: O2Vent W
Oventus Manufacturing Pty Ltd     510(k) NO: K171316(Special)
ATTN: Hemangi  Malde              PHONE NO : 61 7 31803196 
1 Swann Road                      SE DECISION MADE: 11-JUL-17
Indooroopilly  AU 4068            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 20G x 5/8" Pro-Lock CT Safety Infusion Set
Medcomp (dba Medical Components, I510(k) NO: K171333(Special)
ATTN: Courtney  Nix               PHONE NO : 215 2564201 
1499 Delp Drive                   SE DECISION MADE: 18-JUL-17
Harleysville PA  19438            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs
ECO MEDI GLOVE SDN. BHD           510(k) NO: K171339(Traditional)
ATTN: Suresh  Kumar               PHONE NO : 603 60 283033 
Lot 23826, Jalan Tembaga Kuning KaSE DECISION MADE: 07-JUL-17
Kamunting Perak  MY 34600         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MP LeFort I Plates
Stryker                           510(k) NO: K171364(Special)
ATTN: Gregory  Gohl               PHONE NO : 269 3894319 
750 Trade Centre Way Suite 200    SE DECISION MADE: 24-JUL-17
Portage MI  49002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dermal Cooling System
R2 Dermatology ,Inc               510(k) NO: K171398(Traditional)
ATTN: Kristine  Tatsutani         PHONE NO : 925 3784400 
2633 Camino Ramon, Suite 130      SE DECISION MADE: 06-JUL-17
San Ramon CA  94583               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
ELITechGroup                      510(k) NO: K171401(Traditional)
ATTN: Valerie  Gourdon            PHONE NO : 33 023 3812100 
Zone Industrielle                 SE DECISION MADE: 11-JUL-17
Sees  FR 61500                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)
BAUSCH + LOMB Incorporated        510(k) NO: K171404(Traditional)
ATTN: Glenn A. Davies             PHONE NO : 585 3388215 
1400 North Goodman Street         SE DECISION MADE: 17-JUL-17
Rochester NY NY  14609            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System
Globus Medical Inc.               510(k) NO: K171413(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 1670
2560 General Armistead Ave.       SE DECISION MADE: 14-JUL-17
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nasal Alar SpO2 Sensor
Xhale, Inc                        510(k) NO: K171423(Traditional)
ATTN: Jeffrey  Hoebelheinrich     PHONE NO : 352 3718488 
3630 SW 47th Ave, Suite 100       SE DECISION MADE: 27-JUL-17
Gainesville FL  32608             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CONCORDE LIFT
Medos International, SARL         510(k) NO: K171425(Traditional)
ATTN: Karen  Sylvia               PHONE NO : 508 9773804 
Chemin-Blanc 38                   SE DECISION MADE: 20-JUL-17
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System
Medos International SARL          510(k) NO: K171439(Traditional)
ATTN: Catherine  Kilshaw          PHONE NO : 508 8808412 
Chemin-Blanc 38                   SE DECISION MADE: 20-JUL-17
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit
Luminex Corporation               510(k) NO: K171441(Traditional)
ATTN: Wendy  Ricker               PHONE NO : 608 2038936 
12212 Technology Blvd.            SE DECISION MADE: 21-JUL-17
Austin TX  78727                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hammertoe Correction System
Life Spine Inc.                   510(k) NO: K171448(Traditional)
ATTN: Randy  Lewis                PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 07-JUL-17
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Interject Injection Therapy Needle Catheter
Boston Scientific Corporation     510(k) NO: K171454(Traditional)
ATTN: Tara  Paul                  PHONE NO : 508 6834296 
100 Boston Scientific Way         SE DECISION MADE: 07-JUL-17
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SkyPlate Detector for Philips Radiography/Fluoroscopy Systems
Philips Medical Systems DMC GmbH  510(k) NO: K171461(Traditional)
ATTN: Ming  Xiao                  PHONE NO : 49 405 0782306 
Roentgenstrasse 24-26             SE DECISION MADE: 07-JUL-17
Hamburg  DE 22335                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NHAC 16
LMT Medical Systems GmbH          510(k) NO: K171515(Special)
ATTN: Thomas  Plein               PHONE NO : 49 451 580980 
Maria-Goeppert-Str. 5             SE DECISION MADE: 26-JUL-17
Lubeck  DE 23562                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: truFreeze Rapid AV Spray Kit
CSA Medical, Inc.                 510(k) NO: K171522(Traditional)
ATTN: Sherrie  Coval-Goldsmith    PHONE NO : 781 5384720 
91 Hartwell Avenue                SE DECISION MADE: 14-JUL-17
Lexington MA  02421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Contact Lens Case
E-Link Plastic & Metal Industrial 510(k) NO: K171539(Traditional)
ATTN: Marvis  Lee                 PHONE NO : 886 229 011777 
No.69-40, Hsing Shuh Rd. Hsing ChuSE DECISION MADE: 14-JUL-17
New Taipei  CN 24262              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arterys Viewer
Arterys Inc.                      510(k) NO: K171544(Traditional)
ATTN: Golnaz  Moeini              PHONE NO : 408 5043187 
51 Federal Street Suite 305       SE DECISION MADE: 18-JUL-17
San Francisco CA  94107           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: True Spinal Fixation System
Innovative Surgical Designs, Inc. 510(k) NO: K171559(Traditional)
ATTN: Jon  Rinehart               PHONE NO : 217 8368522 
3903 S. Walnut St.                SE DECISION MADE: 24-JUL-17
Bloomington IN  47401             510(k) STATEMENT
                                                    

DEVICE: NuBODY Skin Toning Device
Carol Cole Company dba NuFACE     510(k) NO: K171588(Traditional)
ATTN: Donald  Ellis               PHONE NO : 760 5091264 
1325 Sycamore Ave, Suite A        SE DECISION MADE: 31-JUL-17
Vista CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vantage Elan 1.5T, V4.0
Toshiba Medical Systems Corporatio510(k) NO: K171597(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 21-JUL-17
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Williams Cystoscopic Injection Needle
Cook Incorporated                 510(k) NO: K171602(Traditional)
ATTN: Rebecca  Odulio (Li-chun LiuPHONE NO : 812 3353575 104673
750 Daniels Way, P.O. Box 489     SE DECISION MADE: 28-JUL-17
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bronchi and Gastrointestinal Cytology Brush
Wilson-Cook Medical, Inc. / Cook E510(k) NO: K171607(Traditional)
ATTN: Doris A. Hawks              PHONE NO : 336 7440157 396293
4900 Bethania Station Road        SE DECISION MADE: 31-JUL-17
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip
Asahi Intecc Co., Ltd.            510(k) NO: K171613(Special)
ATTN: Yasuyuki  Kawahara          PHONE NO : 81 52 7681211 
1703 Wakita-cho, Moriyama-Ku      SE DECISION MADE: 01-JUL-17
Nagoya  JP 463-0024               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xingyu Nitrile Powder Free Patient Examination Gloves, White color
Shandong Xingyu Gloves Co., Ltd   510(k) NO: K171615(Traditional)
ATTN: Xu  Qiang                   PHONE NO : 86 536 2588123 
No.2158,Yaoqian Road,Economic DeveSE DECISION MADE: 31-JUL-17
Gaomi  CN 261502                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color
Shandong Xingyu Gloves Co., Ltd   510(k) NO: K171616(Traditional)
ATTN: Xu  Qiang                   PHONE NO : 86 536 2588123 
No.2158,Yaoqian Road,Economic DeveSE DECISION MADE: 20-JUL-17
Gaomi  CN 261502                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nasal Pancreatic Drainage Set
Cook Ireland Ltd                  510(k) NO: K171623(Traditional)
ATTN: Orla  Gunning               PHONE NO : 011 353 61334440 2895
O'Halloran Road, National TechnoloSE DECISION MADE: 31-JUL-17
Limerick  IE                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LumFuse-TP
Precifit Medical Ltd              510(k) NO: K171630(Traditional)
ATTN: ZhenYu (Eric) Wu            PHONE NO : 
951 Aviation Pkwy Ste 100         SE DECISION MADE: 25-JUL-17
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle
Strukmyer Medical                 510(k) NO: K171645(Traditional)
ATTN: Pamela  Liberto             PHONE NO : 972 2841614 
1801 Big Town Blvd Suite #100     SE DECISION MADE: 25-JUL-17
Mesquite TX  75149                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: YOGA Microcatheter, 0.032", 150cm, Back Up and Extra Back Up
Codman & Shurtleff, Inc.          510(k) NO: K171653(Special)
ATTN: Yoon Hee Beatty             PHONE NO : 305 2652919 
325 Paramount Drive               SE DECISION MADE: 03-JUL-17
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Genesys Spine Apache Interbody Fusion System
Genesys Spine                     510(k) NO: K171656(Special)
ATTN: Brian J. Bergeron           PHONE NO : 512 3817071 
1250 South Capital of Texas HighwaSE DECISION MADE: 13-JUL-17
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MPR2 logO DATALOGGER
Raumedic AG                       510(k) NO: K171666(Third Party - Traditional)
ATTN: Reiner  Thiem               PHONE NO : 0049 9252 3592782 
Hermann-Staudinger-Strasse 2      SE DECISION MADE: 06-JUL-17
Helmbrechts  DE 95233             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: g.Nautilus PRO
g.tec medical engineering GmbH    510(k) NO: K171669(Third Party - Traditional)
ATTN: Christoph  Guger            PHONE NO : 43 725 12224012 
Sierningstrasse14                 SE DECISION MADE: 05-JUL-17
Schiedlberg  AT 4521              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Smart Syringe
Osprey Medical, Inc.              510(k) NO: K171698(Special)
ATTN: Melanie  Hess               PHONE NO : 952 9558252 
5600 Rowland Road Suite 250       SE DECISION MADE: 07-JUL-17
Minnetonka MN  55343              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System
Intuitive Surgical, Inc           510(k) NO: K171699(Traditional)
ATTN: Brandon  Hansen             PHONE NO : 408 5232100 
1266 Kifer Road                   SE DECISION MADE: 28-JUL-17
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GelPOINT Path Transanal Access Platform
Applied Medical Resources Corp.   510(k) NO: K171701(Traditional)
ATTN: Corinne  Weisheit           PHONE NO : 949 7138176 
22872 Avenida Empresa             SE DECISION MADE: 20-JUL-17
Rancho Santa Margarita CA  92688  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thunder, Thunder VT, Thunder HR
Quanta System S.p.A.              510(k) NO: K171711(Special)
ATTN: Francesco  Dell'Antonio     PHONE NO : 39 033 1376797 
Via acquedotto, 109               SE DECISION MADE: 07-JUL-17
Samarate  IT 20826                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rampart L Lumbar Interbody Fusion Device
Spineology Inc.                   510(k) NO: K171724(Special)
ATTN: Jacqueline A. Hauge         PHONE NO : 651 2568500 
7800 3rd Street N., Suite 600     SE DECISION MADE: 24-JUL-17
St. Paul MN  55128-5455           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hydrocleanse Antimicrobial Skin and Wound Care Solution
Sonoma Pharmaceuticals            510(k) NO: K171727(Traditional)
ATTN: Brian W. Martin             PHONE NO : 707 2830550 
1129 N. McDowell Boulevard        SE DECISION MADE: 26-JUL-17
Petaluma CA  94954                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TrueBeam, TrueBeam STx, Edge
Varian Medical Systems, Inc.      510(k) NO: K171733(Special)
ATTN: Sara  Muddell               PHONE NO : 650 4246631 
911 Hansen Way                    SE DECISION MADE: 12-JUL-17
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HP PRO Positioning Device
Orfit Industries NV               510(k) NO: K171734(Third Party - Traditional)
ATTN: Eddy  Marivoet              PHONE NO : 32 03 3606015 
9A, Vosveld                       SE DECISION MADE: 25-JUL-17
Wijnegem  BE 2110                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System,  MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System
Codman & Shurtleff, Inc.          510(k) NO: K171747(Special)
ATTN: Vivian  Perez               PHONE NO : 305 2656810 
325 Paramount Drive               SE DECISION MADE: 14-JUL-17
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Velofix(tm) Interbody Fusion System
U&i Corporation                   510(k) NO: K171749(Traditional)
ATTN: Jee Ae Bang                 PHONE NO : 82 31 8606846 
20, Sandan-ro 76beon-gil(Rd)      SE DECISION MADE: 13-JUL-17
Uijeongbu-si  KR 11781            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16
Leica Biosystems Newcastle Limited510(k) NO: K171753(Special)
ATTN: Bert  Peerboom              PHONE NO : 044 191 2154216 
Balliol Business Park West, BentonSE DECISION MADE: 21-JUL-17
Newcastle Upon Tyne  GB NE12 8EW  510(k) STATEMENT
                                                    

DEVICE: NovaPACS
Novarad Corporation               510(k) NO: K171754(Traditional)
ATTN: Doug  Merrill               PHONE NO : 801 6421001 
752 East 1180 South #200          SE DECISION MADE: 28-JUL-17
American Fork UT  84003           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acuson SC2000 Diagnostic Ultrasound System
Siemens Medical Solutions Inc.    510(k) NO: K171766(Third Party - Traditional)
ATTN: Kevin  Kong                 PHONE NO : 650 9699112 
685 East Middlefield Road         SE DECISION MADE: 12-JUL-17
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: OrthAlign Plus System
OrthAlign, Inc.                   510(k) NO: K171780(Special)
ATTN: David  Vancelette           PHONE NO : 949 7152424 
120 Columbia, Suite 500           SE DECISION MADE: 11-JUL-17
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OEC Elite MiniView
GE Hualun Medical Systems Co.Ltd. 510(k) NO: K171800(Special)
ATTN: Lifeng  Wang                PHONE NO : 86 10 57083145 
No1 YongChang North Road, Beijing SE DECISION MADE: 12-JUL-17
Beijing  CN 100176                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ES2 Neuromonitoring Accessory Instruments
Stryker Corporation               510(k) NO: K171807(Special)
ATTN: Nikin  Desai                PHONE NO : 201 7608043 
2 Pearl Court                     SE DECISION MADE: 18-JUL-17
Allendale NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nio Color 2MP (MDNC-2123)
Barco NV                          510(k) NO: K171812(Special)
ATTN: Helena  Soenen              PHONE NO : 32 562 33528 
President Kennedypark 35          SE DECISION MADE: 19-JUL-17
Kortrijk  BE 8500                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System
L&K BIOMED Co., Ltd.              510(k) NO: K171813(Special)
ATTN: Yerim  An                   PHONE NO : 82 2 67171985 
#201, 202 16-25, Dongbaekjungang-rSE DECISION MADE: 13-JUL-17
Giheung-gu, Yongin-si  KR 17015   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System
Edan Instruments Inc              510(k) NO: K171824(Traditional)
ATTN: Alice  Yang                 PHONE NO : 86 7552 6858736 
#15 Jinhui Road,Jinsha Community, SE DECISION MADE: 18-JUL-17
Shenzhen  CN 518067               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TomoTherapy Treatment Delivery System with iDMS
Accuray Incorporated              510(k) NO: K171837(Traditional)
ATTN: Keith  Picker               PHONE NO : 608 8243069 
1240 Deming Way                   SE DECISION MADE: 25-JUL-17
Madison WI  53717                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TiLock2 Spinal System
Genesys Spine                     510(k) NO: K171838(Special)
ATTN: William W. Sowers           PHONE NO : 512 3817080 
1250 Capital of Texas Highway SoutSE DECISION MADE: 19-JUL-17
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Inspire ICE aka Inspire ICE Clear Brackets
Ormco Corporation                 510(k) NO: K171844(Third Party - Traditional)
ATTN: Tara  Bonny                 PHONE NO : 909 9625856 
1717 W. Collins Avenue            SE DECISION MADE: 18-JUL-17
Orange CA  92867                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: External Moisturizing Gel
Combe Incorporated                510(k) NO: K171855(Special)
ATTN: Richard  Grabarz            PHONE NO : 914 4614467 
1101 Westchester Avenue           SE DECISION MADE: 21-JUL-17
White Plains NY  10604            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Radiance V4
GMV Soluciones Globales Internet S510(k) NO: K171885(Special)
ATTN: Carlos  Illana              PHONE NO : 34 9180 72100 
Calle de Isaac Newton, 11         SE DECISION MADE: 25-JUL-17
Tres Cantos  ES 28760             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VISCO 360 Viscosurgical System
Sight Sciences, Inc.              510(k) NO: K171905(Special)
ATTN: Anne-Marie  Ripley          PHONE NO : 1 661 6458546 
3000 Sand Hill Road, Building 3 SuSE DECISION MADE: 27-JUL-17
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitality® Spinal Fixation System
Zimmer Biomet Spine, Inc.         510(k) NO: K171907(Special)
ATTN: Kelly  Stratton             PHONE NO : 303 5018386 
10225 Westmoor Drive              SE DECISION MADE: 14-JUL-17
Westminster CO  80021             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
3M Company                        510(k) NO: K171908(Special)
ATTN: Melissa  Forth              PHONE NO : 651 7375016 
3M Center, 2510 Conway Ave, Bldg 2SE DECISION MADE: 11-JUL-17
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rubicon 14, 18 and 35 Support Catheters
Boston Scientific Corporation     510(k) NO: K171913(Special)
ATTN: Ka Zoua Xiong               PHONE NO : 763 4942970 
Three Scimed Place                SE DECISION MADE: 25-JUL-17
Maple Grove MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Discovery Pico, Discovery Pico Plus
Quanta System S.p.A.              510(k) NO: K171945(Traditional)
ATTN: Francesco  Dell'Antonio     PHONE NO : 39 033 1376797 
Via Acquedotto, 109               SE DECISION MADE: 28-JUL-17
Samarate  IT 20826                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MaxZero Extension Sets with Needless Connector
Carefusion 303 Inc.               510(k) NO: K171957(Third Party - Traditional)
ATTN: Viviana  Lai                PHONE NO : 714 9227679 
10020 Pacific Mesa Blvd           SE DECISION MADE: 19-JUL-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Klassic HD® Hip System
Total Joint Othopedics, Inc.      510(k) NO: K171962(Special)
ATTN: Chris  Weaber               PHONE NO : 801 4866070 
1567 E. Stratford Avenue          SE DECISION MADE: 24-JUL-17
Salt Lake City UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MagVita TMS Therapy System
Tonica Elektronik A/S             510(k) NO: K171967(Special)
ATTN: Lise  Terkelsen             PHONE NO : 45 44 998444 
Lucernemarken 15                  SE DECISION MADE: 25-JUL-17
Farum  DK                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Performer Introducer
Cook Incorporated                 510(k) NO: K171999(Special)
ATTN: Jennifer  Allman            PHONE NO : 812 3353575 104280
750 Daniels Way                   SE DECISION MADE: 31-JUL-17
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VitalBeam
Varian Medical Systems, Inc.      510(k) NO: K172013(Special)
ATTN: Peter J. Coronado           PHONE NO : 1 650 4246320 
911 Hansen Way                    SE DECISION MADE: 28-JUL-17
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Litho 60
quanta system spa                 510(k) NO: K172025(Special)
ATTN: Francesco  Dell' Antonio    PHONE NO : 39 033 1376797 
via acquedotto 109                SE DECISION MADE: 31-JUL-17
samarate (Va)  IT 21017           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: truFreeze System
CSA Medical, Inc.                 510(k) NO: K172041(Special)
ATTN: Sherrie  Coval-Goldsmith    PHONE NO : 781 5384720 
91 Hartwell Avenue                SE DECISION MADE: 27-JUL-17
Lexington MA  02421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    


    TOTAL 510(k)s THIS PERIOD   245                                     
    TOTAL WITH SUMMARIES        233                                     
    TOTAL WITH STATEMENTS        12
                                      

Page Last Updated: 12/06/2017
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