U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. Device Approvals, Denials and Clearances
  5. 510(k) Clearances
  6. September 2017 510(k) Clearances
  1. Device Approvals, Denials and Clearances

September 2017 510(k) Clearances

September 2017 510(k) Clearances

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


DEVICE: Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)
LI-TEK ELECTRONICS TECHNOLOGIES   510(k) NO: K161434(Traditional)
ATTN: BARRY   YUAN                PHONE NO : 0769  83117755 
NO. 8-13, INDUSTRIAL PARK OF JINSHSE DECISION MADE: 28-SEP-17
DONGGUAN CITY  CN                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)
SHENZHEN HOMED MEDICAL DEVICE CO.,510(k) NO: K161586(Traditional)
ATTN: Shengming  Shi              PHONE NO : 86 755 29821675 8011
NO.2 BUILDING, LONGGU INDUSTRIAL ZSE DECISION MADE: 06-SEP-17
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Salter Labs Bubble Humidifier
SALTER LABS                       510(k) NO: K161719(Traditional)
ATTN: MARA  CALER                 PHONE NO : 760 7957094 
2365 CAMINO VIDA ROBLE            SE DECISION MADE: 21-SEP-17
Carlsbad CA  92011                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: S4 Screw System™
SUBCHONDRAL SOLUTIONS             510(k) NO: K162171(Traditional)
ATTN: SHERYL  MCCOY               PHONE NO : 408 8919604 
147 HILLBROOK DRIVE               SE DECISION MADE: 07-SEP-17
LOS GATOS CA  95032               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A.B. DENTAL DEVICES Dental Implants System
A. B. Dental Device Ltd.          510(k) NO: K162482(Traditional)
ATTN: Gabi  Krauss                PHONE NO : 972 8 8531388 
19 Hayalomim St.                  SE DECISION MADE: 15-SEP-17
Ashdod  IL 77101                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Winback Back 3SE
WINBACK USA CORP                  510(k) NO: K162828(Traditional)
ATTN: CHEICK  KONGO               PHONE NO : 
302 HIGH PLAINS DR                SE DECISION MADE: 18-SEP-17
DRIPPING SPRINGS TX  78620        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann CARES Golden Ti/TiN Abutments
INSTITUT STRAUMANN AG             510(k) NO: K162848(Traditional)
ATTN: Christopher  Klaczyk        PHONE NO : 41 61 9651260 
Peter Merian Weg 12               SE DECISION MADE: 22-SEP-17
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOWCARDIO SYSTEM
CONTEX INTERNATIONAL TECHNOLOGIES 510(k) NO: K162956(Abbreviated)
ATTN: RICARDO  RODRIGUEZ          PHONE NO : 905 6778324 
2798 THAMESGATE DRIVE, UNITS 5&6  SE DECISION MADE: 22-SEP-17
MISSISSAUGA  CA L4T 4E8           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Finger Pulse Oximeter
SHENZHEN FITFAITH TECHNOLOGY CO.,L510(k) NO: K163135(Traditional)
ATTN: Yuan  Junfeng               PHONE NO : 86 0755 2954425380 
AREA B, FLOOR 9, BUILDING D1, TANGSE DECISION MADE: 19-SEP-17
Guangming New District, Shenzhen  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BePOD® Foot Screws
Fournitures Hospitalieres Industri510(k) NO: K163148(Traditional)
ATTN: Patricia  Donnard           PHONE NO : 33 2 98556895 
ZI de Kernevez - 6 rue Nobel      SE DECISION MADE: 14-SEP-17
Quimper  FR                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fiagon Navigation System
FIAGON GMBH                       510(k) NO: K163209(Traditional)
ATTN: Dirk  Mucha                 PHONE NO : 49 3302 2012110 
NEUENDORFSTRASSE 23B              SE DECISION MADE: 14-SEP-17
HENNIGSDORF  DE 16761             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AnemoCheck
SANGUINA, LLC                     510(k) NO: K163215(Traditional)
ATTN: ERIKA  TYBURSKI             PHONE NO : 305 3083267 
575 14TH STREET                   SE DECISION MADE: 13-SEP-17
ATLANTA GA  30318                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ISEN-Goggles with Data Viewer
ISENT TECH & TRADING COMPANY,LTD. 510(k) NO: K163270(Traditional)
ATTN: MARTIN  LIU                 PHONE NO : 86 10 51627072 
RM509, BLDG A, CYBERTOWER, NO.2 ZHSE DECISION MADE: 25-SEP-17
BEIJING  CN 100086                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
HAMILTON MEDICAL AG               510(k) NO: K163283(Traditional)
ATTN: Steffen  Boden              PHONE NO : 41 58 6101842 
VIA CRUSCH 8                      SE DECISION MADE: 20-SEP-17
BONADUZ  CH 7402                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford
SPECTRA MEDICAL DEVICES           510(k) NO: K163292(Traditional)
ATTN: SCOTT  HENDERSON            PHONE NO : 978 6570889 
260-H FORDHAM ROAD                SE DECISION MADE: 08-SEP-17
WILMINGTON MA  01887              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Senographe Pristina
GE Healthcare                     510(k) NO: K163302(Traditional)
ATTN: Camille  Vidal              PHONE NO : 1 240 2805356 
283 rue de la Miniere             SE DECISION MADE: 01-SEP-17
Buc  FR 78530                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartEP
INTELLIGENT HEARING SYSTEMS       510(k) NO: K163326(Traditional)
ATTN: Edward  Miskiel             PHONE NO : 305 668 6102
6860 SW 81ST st Street            SE DECISION MADE: 29-SEP-17
MIAMI FL  33143                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OMNIBotics Knee System
OMNllife Science Inc.             510(k) NO: K163338(Traditional)
ATTN: Daniel  Decruppe            PHONE NO : 800 448 6664
480 Paramount Drive               SE DECISION MADE: 01-SEP-17
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Confirm Rx Insertable Cardiac Monitor (ICM) System
St. Jude Medical, Inc.            510(k) NO: K163407(Traditional)
ATTN: Jennifer  Dunham            PHONE NO : 818 3626822 
15900 Valley View Ct.             SE DECISION MADE: 29-SEP-17
Sylmar CA  91342                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Shanghai Sanyou PEEK Cage System
SHANGHAI SANYOU MEDICAL CO, LTD   510(k) NO: K163422(Traditional)
ATTN: David  Fan                  PHONE NO : 86 21 58389980 
1988 JIATANG ROAD                 SE DECISION MADE: 18-SEP-17
JIADIANG DISTRICT  CN 201807      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITROS Chemistry Products GLU Slides
Ortho Clinical Diagnostics        510(k) NO: K163433(Traditional)
ATTN: Darlene J. Phillips         PHONE NO : 585 4534253 
100 Indigo Creek Drive            SE DECISION MADE: 18-SEP-17
Rochester NY  14626               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NaviENT
ClaroNav Inc.                     510(k) NO: K163439(Traditional)
ATTN: Ahmad  Kolahi               PHONE NO : 647 9511525 
1140 Sheppard Avenue West - Unit 1SE DECISION MADE: 01-SEP-17
Toronto  CA M3K 2A2               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)
Modern Medical Equipment Manufactu510(k) NO: K163442(Traditional)
ATTN: Thomas Tsz Fung Chan        PHONE NO : 852 2420 9068 
35-41 Tai Lin Pai Rd, Unit F 5th FSE DECISION MADE: 28-SEP-17
Hong Kong  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GrindCare System
SUNSTAR SUISSE S.A.               510(k) NO: K163448(Traditional)
ATTN: Olivier  Ducamp             PHONE NO : 41 21 8210652 
Route de Pallatex 11              SE DECISION MADE: 01-SEP-17
Etoy  CH 1163                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SurgiCube
SURGICUBE INTERNATIONAL B.V.      510(k) NO: K163455(Traditional)
ATTN: GER  VIJFVINKEL             PHONE NO : 31 018 1760660 
SEGGELANT-NOORD 4                 SE DECISION MADE: 28-SEP-17
VIERPOLDERS  NL 3237 MG           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
Radiometer Medical ApS            510(k) NO: K163462(Traditional)
ATTN: Per Pape Thomsen            PHONE NO : 45 3827 3304 
Aakandevej 21                     SE DECISION MADE: 21-SEP-17
Broenshoej  DK 2700               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)
BMC MEDICAL.,LTD.                 510(k) NO: K163464(Traditional)
ATTN: Jiang  Huiqi                PHONE NO : 86 10 51663880 705
ROOM 110 TOWER A FENGYU BUILDING, SE DECISION MADE: 05-SEP-17
Haidian  CN 100036                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: hemochroma PLUS System
IMMUNOSTICS, INC.                 510(k) NO: K163465(Traditional)
ATTN: ANTOINETTE  PRUSIK          PHONE NO : 732 9180770 
1750 BRIELLE AVE. A5              SE DECISION MADE: 08-SEP-17
OCEAN NJ  07712                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Poseidon Ultrasound System
BUTTERFLY NETWORK, INC.           510(k) NO: K163510(Traditional)
ATTN: BRIAN  SAWIN                PHONE NO : 203 2046600 
530 OLD WHITFIELD STREET          SE DECISION MADE: 06-SEP-17
GUILFORD CT  06437                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Thermometer
JOYTECH HEALTHCARE CO., LTD       510(k) NO: K163518(Traditional)
ATTN: Ren  Yunhua                 PHONE NO : 86 571 81957767 
No. 365, Wuzhou Road Yuhang EconomSE DECISION MADE: 19-SEP-17
Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
Inova Diagnostics, Inc.           510(k) NO: K163525(Traditional)
ATTN: Peter  Martis               PHONE NO : 858 5869900 1399
9900 Old Grove Road               SE DECISION MADE: 05-SEP-17
San Diego CA  92131-1638          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls
INOVA DIAGNOSTICS, INC.           510(k) NO: K163538(Traditional)
ATTN: ROGER  ALBESA               PHONE NO : 858 5869900 1391
9900 OLD GROVE ROAD               SE DECISION MADE: 06-SEP-17
SAN DIEGO CA  92131               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MediClear PreOp
COVALON TECHNOLOGIES, INC.        510(k) NO: K163556(Traditional)
ATTN: KIM  CROOKS                 PHONE NO : 905 5688400 265
1660 TECH AVENUE UNIT 5           SE DECISION MADE: 14-SEP-17
MISSISSSAUGA  CA L4W 5S7          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ecofit® Hip System
Implantcast GmbH                  510(k) NO: K163577(Traditional)
ATTN: Juliane  Hoeppner           PHONE NO : 49 416 1744135 
Lueneburger Schanze 26            SE DECISION MADE: 25-SEP-17
Buxtehude  DE 21614               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Psychemedics Microplate EIA for Benzodiazepines in Hair
Psychemedics Corporation          510(k) NO: K163590(Traditional)
ATTN: Virginia  Hill              PHONE NO : 310 2167776 
5832 Uplander Way                 SE DECISION MADE: 15-SEP-17
Culver City CA  90230             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pain Therapy Device
Guangzhou Xinbo Electronic Co., Lt510(k) NO: K163611(Traditional)
ATTN: Sammy  Li                   PHONE NO : 86 20 66393598 
2nd Building, Juntuo Industry ParkSE DECISION MADE: 19-SEP-17
Guangzhou  CN 511400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PENTAX Medical ED34-i10T, Video Duodenoscope
PENTAX Medical                    510(k) NO: K163614(Traditional)
ATTN: Kanchana  Iyer              PHONE NO : 800 4315880 5170
3 Paragon Drive                   SE DECISION MADE: 20-SEP-17
Montvale NJ  07645                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Shotel Ankle Arthrodesis Nail System
BioPro, Inc.                      510(k) NO: K163627(Traditional)
ATTN: Dave  Mrak                  PHONE NO : 810 9827777 101
2929 Lapeer Road                  SE DECISION MADE: 14-SEP-17
Port Huron MI  48060              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Health-e-Connect System with IDA
ALR TECHNOLOGIES                  510(k) NO: K163664(Traditional)
ATTN: SIDNEY  CHAN                PHONE NO : 203 7621073 
7400 BEAUFONT SPRINGS DRIVE, SUITESE DECISION MADE: 18-SEP-17
RICHMOND VA  23225                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: neuro | inspire
Rensihaw plc                      510(k) NO: K163666(Traditional)
ATTN: Roberto  Liddi              PHONE NO : 440 1453 524600 
New Mills                         SE DECISION MADE: 15-SEP-17
Wotton-under-Edge  GB GL12 8JR    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry
NEO COSMETIQUE                    510(k) NO: K163674(Traditional)
ATTN: NATHALIE  VERNIN            PHONE NO : 331 49 465105 
15 RUE MONTJOIE                   SE DECISION MADE: 22-SEP-17
SAINT DENIS  FR 93212             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook
ALN Implants Chirurgicaux         510(k) NO: K163699(Abbreviated)
ATTN: Alain  Nigon                PHONE NO : 33 494 010501 
589 Chemin du Niel                SE DECISION MADE: 08-SEP-17
Bormes les Mimosas  FR 83230      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BePOD® EZ Weil Screws
Fournitures Hospitalieres Industri510(k) NO: K163710(Traditional)
ATTN: Patricia  Donnard           PHONE NO : 33 2 98556898 
Zi de Kernevez - 6 rue Nobel      SE DECISION MADE: 08-SEP-17
Quimper  FR 29000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Blood Collection Set
Medline Industries, Inc.          510(k) NO: K170002(Traditional)
ATTN: Matt  Clausen               PHONE NO : 847 6434785 
One Medline Place                 SE DECISION MADE: 19-SEP-17
Mundelein IL  60060               510(k) STATEMENT
                                                    

DEVICE: Eztetic BellaTek Encode Healing Abutments
BIOMET 3I                         510(k) NO: K170013(Traditional)
ATTN: KRUPAL  PATEL               PHONE NO : 561 7766923 
4555 RIVERSIDE DR                 SE DECISION MADE: 21-SEP-17
PALM BEACH GARDENS FL  33410      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Peel-Away Introducer Set
Cook Incorporated                 510(k) NO: K170020(Traditional)
ATTN: Colin  Jacob                PHONE NO : 812 3353575 104965
750 Daniels Way, P.O. Box 489     SE DECISION MADE: 28-SEP-17
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP
Fysicon BV                        510(k) NO: K170032(Traditional)
ATTN: C.W.A (Eric)  Van Antwerpen PHONE NO : 31 412 653333 
Hoogheuvelstraat 114              SE DECISION MADE: 08-SEP-17
Oss  NL 5349 BA                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XableCath Support Catheter
XABLECATH, INC.                   510(k) NO: K170041(Traditional)
ATTN: RICK  GAYKOWSKI             PHONE NO : 617 4474000 
417 S WAKARA WAY STE. 3510        SE DECISION MADE: 07-SEP-17
SALT LAKE CITY UT  84108-1457     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: All-in-One Health Monitor, PC-303
Shenzhen Creative Industry Co., Lt510(k) NO: K170047(Traditional)
ATTN: Jia  Wang                   PHONE NO : 86 755 26431671 
2/F, Block 3, Nanyou Tian'an IndusSE DECISION MADE: 09-SEP-17
Shenzhen  CN 518054               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Scanostics UTI Check Application Test System
Teco Diagnostics                  510(k) NO: K170118(Traditional)
ATTN: Ling  Koh                   PHONE NO : 714 4631111 
1268 N Lakeview Ave               SE DECISION MADE: 21-SEP-17
Anaheim CA  92807                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Calix Lumbar Spinal Implant System
X-Spine Systems, Inc.             510(k) NO: K170119(Traditional)
ATTN: Charlene  Brumbaugh         PHONE NO : 937 8478400 2192
452 Alexandersville Rd.           SE DECISION MADE: 29-SEP-17
Miamisburg OH  45342              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INDEPENDENCE® Spacers
Globus Medical Inc.               510(k) NO: K170157(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 1670
2560 General Armistead Ave.       SE DECISION MADE: 25-SEP-17
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vesco Medical Nasoenteric Feeding Tubes
Vesco Medical, LLC                510(k) NO: K170162(Traditional)
ATTN: Chris  O'Keefe              PHONE NO : 614 9145991 
692 N. High Street, Suite 205     SE DECISION MADE: 26-SEP-17
Columbus OH  43215                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture
CPT Sutures Co., Ltd.             510(k) NO: K170166(Traditional)
ATTN: Khoa  Do                    PHONE NO : 84 8 38222228 
8 Dao Tri Street                  SE DECISION MADE: 29-SEP-17
Phu Thuan Ward District 7  VN     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Masimo Rad-97 and Accessories
MASIMO CORPORATION                510(k) NO: K170168(Traditional)
ATTN: MARGUERITE  THOMLINSON      PHONE NO : 949 2977592 
52 DISCOVERY                      SE DECISION MADE: 14-SEP-17
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
Lumenis Ltd.                      510(k) NO: K170179(Traditional)
ATTN: Amaya De Levie              PHONE NO : 972 4 9599085 
6 Hakidma Street PO Box 240       SE DECISION MADE: 18-SEP-17
Yokneam  IL 2069204               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prizma
G-Medical Innovations Ltd.        510(k) NO: K170181(Traditional)
ATTN: N.  Epstein                 PHONE NO : 972 8 9584777 
5 Openheimer St., Park Rabin      SE DECISION MADE: 01-SEP-17
Rehovot  IL 7670105               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cetus system, Cetus probe
A.R.C. Laser GmbH                 510(k) NO: K170183(Traditional)
ATTN: Angela  Thyzel              PHONE NO : 49 911 2177900 
Bessemer St. 14                   SE DECISION MADE: 27-SEP-17
Nurnberg  DE 90411                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: tremoFlo C-100 Airwave Oscillometry System
THORASYS Thoracic Medical Systems,510(k) NO: K170185(Traditional)
ATTN: Sebastien  Jutras           PHONE NO : 1 514 3848555 133
6560 Avenue de l'Esplanade Suite #SE DECISION MADE: 12-SEP-17
Montreal  CA H2v 4l5              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
Given Imaging Ltd.                510(k) NO: K170210(Traditional)
ATTN: Hilla  Debby                PHONE NO : 972 4 9097774 
2 Hacarmet St New Industrial Park SE DECISION MADE: 01-SEP-17
Yoqneam  IL 20692                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5) 
Andon health Co., Ltd             510(k) NO: K170231(Traditional)
ATTN: Yi  Liu                     PHONE NO : 86 22 60526161 
No.3 Jinping Street,Ya An Road, NaSE DECISION MADE: 15-SEP-17
Tianjin  CN 300190                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Thermometer
K-Jump Health Co., Ltd.           510(k) NO: K170262(Abbreviated)
ATTN: JM  Lin                     PHONE NO : 886 2 22991378 
No. 56, Wu Kung 5th Rd., New TaipeSE DECISION MADE: 28-SEP-17
New Taipei City  TW 24890         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tri Auto ZX2
J. MORITA USA, INC.               510(k) NO: K170275(Traditional)
ATTN: KEISUKE  MORI               PHONE NO : 949 5819600 
9 MASON                           SE DECISION MADE: 11-SEP-17
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA
Largan Medical Co. Ltd.           510(k) NO: K170286(Traditional)
ATTN: Amy  Tien                   PHONE NO : 886 4 36000203 
2F., No. 14, 23rd Rd., Taichung InSE DECISION MADE: 18-SEP-17
Taichung  TW 40850                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tri-Ex Extraction Balloon With Multiple Sizing
WILSON-COOK MEDICAL, INC          510(k) NO: K170292(Special)
ATTN: TIFFANNY A. THOMAS          PHONE NO : 336 7440157 396680
4900 BETHANIA STATION ROAD        SE DECISION MADE: 20-SEP-17
WINSTON-SALEM NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Entuit Start Initial Placement Gastrostomy Set
Cook Incorporated                 510(k) NO: K170323(Traditional)
ATTN: Erum B. Nasir               PHONE NO : 812 3353575 102607
450 Daniels Way, P.O. Box 489     SE DECISION MADE: 14-SEP-17
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile NS System
Jeil Medical Corporation          510(k) NO: K170368(Traditional)
ATTN: Seungyong  Lee              PHONE NO : 82 2 8503533 
55 Digital-ro, 34-gil 702, 703, 70SE DECISION MADE: 11-SEP-17
Seoul  KR 152-728                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AirLife Adult Heated Wire BiPAP/NIV Circuit
Vyaire Medical                    510(k) NO: K170378(Traditional)
ATTN: Sharon  Nichols             PHONE NO : 847 3628107 
75 North Fairway Drive            SE DECISION MADE: 14-SEP-17
Vernon Hills IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini
Medtronic Advanced Energy         510(k) NO: K170381(Traditional)
ATTN: Heather  Valley             PHONE NO : 603 2945447 
180 International Drive           SE DECISION MADE: 07-SEP-17
Portsmouth NH  03801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System
Topcon Medical Laser Systems, Inc.510(k) NO: K170409(Traditional)
ATTN: Sweta  Srivastava           PHONE NO : 925 2458300 
606 Enterprise Court              SE DECISION MADE: 12-SEP-17
Livermore CA  94550               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Hemo-Force DVT Compression Sleeve
Medline Industries, Inc.          510(k) NO: K170415(Traditional)
ATTN: Matt  Clausen               PHONE NO : 847 6434785 
Three Lakes Drive                 SE DECISION MADE: 08-SEP-17
Northfield IL  60093              510(k) STATEMENT
                                                    

DEVICE: Glidewire GT
Terumo Corporation                510(k) NO: K170417(Traditional)
ATTN: Monika  McDole-Russell      PHONE NO : 732 3024900 4273
44-1, 2-Chome, Hatagaya           SE DECISION MADE: 15-SEP-17
Shibuya-Ku,  JP 151-0072          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cranial Drill Bits and Accessories
Ad-Tech Medical Instrument Corpora510(k) NO: K170442(Traditional)
ATTN: Lisa  Theama                PHONE NO : 262 6341555 
1901 William Street               SE DECISION MADE: 07-SEP-17
Racine WI  53404                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spider Frame External Fixation System
TASARIMMED TIBBI MAMULLER SANAYI V510(k) NO: K170482(Traditional)
ATTN: Sumru  Alperen              PHONE NO : 90 212 6742244 
Demirkapi Topcular Mahallesi TopcuSE DECISION MADE: 27-SEP-17
Istanbul  TR TR 34055             510(k) STATEMENT
                                                    

DEVICE: Navina Classic System
Dentsply Sirona                   510(k) NO: K170487(Traditional)
ATTN: Karl  Nittinger             PHONE NO : 717 8494424 
221 West Philadelphia Street, SuitSE DECISION MADE: 11-SEP-17
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gems Oocyte Retrieval Buffer ORB-20, ORB-50
Genea Biomedx Pty Ltd             510(k) NO: K170498(Traditional)
ATTN: Kea  Dent                   PHONE NO : 61 2 84847677__ 
Level 2, 321 Kent Street          SE DECISION MADE: 28-SEP-17
Sydney  AU 2000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SecurePortIV Catheter Securement Adhesive
Adhezion Biomedical, LLC          510(k) NO: K170505(Traditional)
ATTN: Richard G. Jones            PHONE NO : 610 2417191 
One Meridian Blvd - Suite 1B02    SE DECISION MADE: 29-SEP-17
Wyomissing PA  19610              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Phoenix Clinical ICON
Phoenix Technology Group, Inc. dba510(k) NO: K170527(Traditional)
ATTN: Christopher A. Henderson    PHONE NO : 925 4625000 
6630 Owens Drive                  SE DECISION MADE: 15-SEP-17
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Mesh Plate System
Arthrex, Inc.                     510(k) NO: K170547(Traditional)
ATTN: Ivette  Galmez              PHONE NO : 239 6435553 71263
1370 Creekside Boulevard          SE DECISION MADE: 01-SEP-17
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TN-Brush
GENOSS Co. Ltd.                   510(k) NO: K170596(Traditional)
ATTN: Hyeyoung  Moon              PHONE NO : 82 70 70986316 
1F, Gyeonggi R&DB Center, 105 GwanSE DECISION MADE: 11-SEP-17
Suwon-si  KR 443-270              510(k) STATEMENT
                                                    

DEVICE: Endoscope Sterilization Tray
Intuitive Surgical, Inc.          510(k) NO: K170640(Traditional)
ATTN: Kunal  Gunjal               PHONE NO : 408 5238017 
1266 Kifer Road Building 101      SE DECISION MADE: 17-SEP-17
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes
Intuitive Surgical, Inc.          510(k) NO: K170641(Traditional)
ATTN: Kunal  Gunjal               PHONE NO : 408 5238017 
1266 Kifer Road, Building 101     SE DECISION MADE: 21-SEP-17
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)
Intuitive Surgical, Inc.          510(k) NO: K170644(Traditional)
ATTN: Kunal  Gunjal               PHONE NO : 408 5238017 
1266 Kifer Road                   SE DECISION MADE: 11-SEP-17
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci Xi EndoWrist Instruments and Accessories
Intuitive Surgical, Inc.          510(k) NO: K170645(Traditional)
ATTN: Kunal  Gunjal               PHONE NO : 408 5238017 
1266 Kifer Road                   SE DECISION MADE: 11-SEP-17
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Locking Pediatric Osteotomy Plate (LolliPOP) System
Pega Medical Inc.                 510(k) NO: K170704(Traditional)
ATTN: Ariel R. Dujovne            PHONE NO : 450 6885144 
1111 Autoroute Chomedey           SE DECISION MADE: 08-SEP-17
Iaval  CA H7W 5J8                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIX Wrist System
Jeil Medical Corporation          510(k) NO: K170705(Traditional)
ATTN: Ji won SONG                 PHONE NO : 82 2 8503587 
                                  SE DECISION MADE: 21-SEP-17
Seoul  KR 152-728                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thermage FLX System and Accessories
Solta Medical                     510(k) NO: K170758(Traditional)
ATTN: Melissa  Thomas             PHONE NO : 510 2595299 
11720 North Creek Pkwy N., Suite 1SE DECISION MADE: 22-SEP-17
Bothell WA  98011                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRAUMACEM™ V+ Injectable Bone Cement
Synthes (USA) Products, LLC       510(k) NO: K170802(Traditional)
ATTN: Christopher J. Medberry     PHONE NO : 1 610 7196806 
1301 Goshen Parkway               SE DECISION MADE: 28-SEP-17
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CRYOFOS
CRYOFOS Medical Gmbh              510(k) NO: K170810(Traditional)
ATTN: Gerlinde  Hornung-Stehling  PHONE NO : 49 0 7212039933 
Lammstrasse 21                    SE DECISION MADE: 27-SEP-17
Karlsruhe  DE 76133               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM
Brainlab AG                       510(k) NO: K170816(Traditional)
ATTN: Rainer  Birkenbach          PHONE NO : 49 899 915680 
Olof-Palme-Str. 9                 SE DECISION MADE: 26-SEP-17
Munchen  DE 81829                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Caries Detector
Ortek Therapeutics, Inc.          510(k) NO: K170822(Traditional)
ATTN: Mitchell  Goldberg          PHONE NO : 516 4844500 
4 Expressway Plaza                SE DECISION MADE: 11-SEP-17
Roslyn Heights NY  11577          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medentika CAD/CAM TiBases
Medentika GmbH                    510(k) NO: K170838(Traditional)
ATTN: Gerhard  Polzer             PHONE NO : 49 07 229699120 
AHammweg 8-10                     SE DECISION MADE: 15-SEP-17
Huegelsheim  DE 76549             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls
Instrumentation Laboratory Co.    510(k) NO: K170854(Traditional)
ATTN: Carol  Marble               PHONE NO : 781 8614467 
180 Hartwell Road                 SE DECISION MADE: 08-SEP-17
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T-Rex Standalone ALIF
SIATS, LLC                        510(k) NO: K170855(Traditional)
ATTN: Robert  Compton             PHONE NO : 918 9952090 
6316 E 102nd Street               SE DECISION MADE: 07-SEP-17
Tulsa OK  74137                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories
Intuitive Surgical, Inc.          510(k) NO: K170875(Traditional)
ATTN: Manjunath  Bisalehalli      PHONE NO : 408 5237089 
1266 Kifer Road, Building 101     SE DECISION MADE: 12-SEP-17
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories
Intuitive Surgical, Inc.          510(k) NO: K170879(Traditional)
ATTN: Kunal  Gunjal               PHONE NO : 408 5238017 
1266 Kifer Road Building 101      SE DECISION MADE: 21-SEP-17
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VIPER PRIME navigated inserter
Medos International, SARL         510(k) NO: K170937(Traditional)
ATTN: Karen  Sylvia               PHONE NO : 508 9773804 
Chemin-Blanc 38                   SE DECISION MADE: 14-SEP-17
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SYSTEM 1E Liquid Chemical Sterilant Processing System
STERIS Corporation                510(k) NO: K170956(Traditional)
ATTN: Tricia  Cregger             PHONE NO : 440 3927189 
5960 Heisley Rd                   SE DECISION MADE: 22-SEP-17
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Epilaser
Epilady 2000 LLC                  510(k) NO: K170970(Traditional)
ATTN: Joseph  Miller              PHONE NO : 972 4 6860400 
3 Hacharash St. Ind. Zone         SE DECISION MADE: 01-SEP-17
Hazor Haglilit  IL 1035102        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuroQuant
CorTechs Labs, Inc                510(k) NO: K170981(Traditional)
ATTN: Kora  Marinkovic            PHONE NO : 858 4599700 
4690 Executive Drive, Suite 250   SE DECISION MADE: 07-SEP-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Urbanek Device
TMJ Services, LLC                 510(k) NO: K170985(Traditional)
ATTN: Anthony  Urbanek            PHONE NO : 615 7712189 
2009 Mallory Lane                 SE DECISION MADE: 25-SEP-17
Franklin TN  37067                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dentis Dental Implant System
Dentis Co.,Ltd.                   510(k) NO: K171027(Traditional)
ATTN: Sun Chul Shin               PHONE NO : 82 53 5822804 
99, Seongseoseo-ro, Dalseo-gu     SE DECISION MADE: 06-SEP-17
Daegu  KR 42718                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Katalyst Mark 1 Muscle Stimulation System
Katalyst Inc.                     510(k) NO: K171035(Traditional)
ATTN: Amish  Patel                PHONE NO : 406 6163671 
316 Occidental Ave. South B300    SE DECISION MADE: 06-SEP-17
Seattle WA  98104                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HORIZON Therapy System
Magstim Company Ltd.              510(k) NO: K171051(Traditional)
ATTN: Tom  Campbell               PHONE NO : 44 019 94240798 
Spring Gardens                    SE DECISION MADE: 13-SEP-17
Whitland  GB SA34 0HR             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INVISION Total Ankle Revision System
Wright Medical Technology, Inc.   510(k) NO: K171067(Traditional)
ATTN: Val  Myles                  PHONE NO : 901 2905162 
1023 Cherry Road                  SE DECISION MADE: 11-SEP-17
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K171107(Traditional)
ATTN: Julie  Bassett              PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 26-SEP-17
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carefusion NeutraClear Needle-free connector (EL-NC1000)
Cair L.G.L                        510(k) NO: K171117(Traditional)
ATTN: Delphine  Molinari          PHONE NO : 33 0 478437707 
1, Allee des Chevreuils - Parc terSE DECISION MADE: 01-SEP-17
Lissieu  FR 69380                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Leksell Vantage Stereotactic System
Elekta Instrument AB              510(k) NO: K171123(Traditional)
ATTN: Matilda  Forsberg           PHONE NO : 011 468 58725400 
Kungstensgatan 18                 SE DECISION MADE: 15-SEP-17
Stockholm  SE 10393               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Implantium II
Dentium Co., Ltd.                 510(k) NO: K171126(Abbreviated)
ATTN: Yoon  Spyoon                PHONE NO : 82 312 072200 
150, Eondong-ro Giheung-gu        SE DECISION MADE: 07-SEP-17
Yongin-si  KR 443-270             510(k) STATEMENT
                                                    

DEVICE: Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel
Medbio LLC.                       510(k) NO: K171144(Traditional)
ATTN: Jatin  Rajani               PHONE NO : 954 5331826 
4846 Citrus Way                   SE DECISION MADE: 12-SEP-17
Cooper City FL  33330             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)
Dimensional Bioceramics LLC       510(k) NO: K171161(Traditional)
ATTN: David  Delaney              PHONE NO : 831 2344892 
163 McKenzie Creek Road           SE DECISION MADE: 25-SEP-17
Scotts Valley CA  95066           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M-CATH Microcatheter
Acrostak (Schweiz) AG             510(k) NO: K171176(Traditional)
ATTN: Carmen  Herraez             PHONE NO : 41 52 2339551 
Stegackerstrasse 14               SE DECISION MADE: 15-SEP-17
Winterthur  CH 8409               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Central Monitoring System
Edan Instruments, Inc.            510(k) NO: K171178(Traditional)
ATTN: Alice  Yang                 PHONE NO : 86 755 26858736 
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 06-SEP-17
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Persyst Mobile App
Persyst Development Corporation   510(k) NO: K171184(Traditional)
ATTN: Dari  Darabbeigi            PHONE NO : 858 4614542 109
420 Stevens Avenue Suite 210      SE DECISION MADE: 21-SEP-17
Solana Beach CA  92075            510(k) STATEMENT
                                                    

DEVICE: AIR-FLOW PLUS Prophylaxis powder
E.M.S. Electro Medical Systems S.A510(k) NO: K171189(Traditional)
ATTN: Suzanne  Fassio-Hardy       PHONE NO : 41 229 944700 
Chemin de la Vuarpilliere 31      SE DECISION MADE: 11-SEP-17
Nyon  CH ch-1260                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuViz Prime Multi-slice CT Scanner System
Neusoft Medical Systems Co., Ltd. 510(k) NO: K171201(Traditional)
ATTN: Shao  Xiancheng             PHONE NO : 86 24 83660645 
No. 16, Shiji Road Hunnan IndustriSE DECISION MADE: 13-SEP-17
Shenyang  CN 110179               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OIC External Fixation System
Orthopaedic Implant Company       510(k) NO: K171211(Traditional)
ATTN: Douglas  Fulton             PHONE NO : 775 6368281 
770 Smithridge Dr. #400           SE DECISION MADE: 27-SEP-17
Reno NV  89502                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AirFit N20
ResMed Ltd                        510(k) NO: K171212(Traditional)
ATTN: Kim Kuan LEE                PHONE NO : 61 2 88841000 
1 Elizabeth Macarthur Drive       SE DECISION MADE: 28-SEP-17
Bella Vista  AU 2153              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QiF Blood and Fluid Warmer
Quality In Flow Ltd.              510(k) NO: K171215(Traditional)
ATTN: Neta  Sherman               PHONE NO : 972 54 6600146 
Kibutz Einat POB 29               SE DECISION MADE: 27-SEP-17
Kibutz Einat  IL 4880500          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PeriView FLEX
Olympus Surgical Technologies Amer510(k) NO: K171232(Traditional)
ATTN: Mary Anne Patella           PHONE NO : 508 8042600 
136 Turnpike Road                 SE DECISION MADE: 21-SEP-17
Southborough MA  01772-2104       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Shenzhen Mindray Bio-Meidcal Elect510(k) NO: K171233(Traditional)
ATTN: Zhai  Pei                   PHONE NO : 0086 0755 81885604 
Mindray Building, Keji 12th Road SSE DECISION MADE: 12-SEP-17
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 014 Hydrophilic Coated PTA Balloon Dilatation Catheter
Creagh Medical                    510(k) NO: K171251(Traditional)
ATTN: Shane  Costello             PHONE NO : 00353 90 9646300 
IDA Business Park                 SE DECISION MADE: 08-SEP-17
Ballinasloe  IE H53 K8P4          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TempSure
Cynosure, Inc                     510(k) NO: K171262(Traditional)
ATTN: Amy  Tannenbaum             PHONE NO : 781 9932454 
5 Carlisle Road                   SE DECISION MADE: 22-SEP-17
Westford MA  01886                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664
University of Texas Medical School510(k) NO: K171303(Traditional)
ATTN: K. Lance Gould              PHONE NO : 713 5006611 
6431 Fannin St. Room 4.256 MSB    SE DECISION MADE: 22-SEP-17
Houston TX  77030                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BR-FHUS Navigation 1.0
TaiHao Medical Inc.               510(k) NO: K171309(Traditional)
ATTN: Hsin Hung Lai               PHONE NO : 886 227 365679 
3F.-8, No.100, Sec. 2 Heping E. RdSE DECISION MADE: 29-SEP-17
Taipei  TW 10663                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clear Vinyl Powder-free Patient Examination Gloves
Shandong Zhi Hong Medical Products510(k) NO: K171317(Traditional)
ATTN: Jennifer  Guo               PHONE NO : 86 189 53331678 
231 Dongqi Industrial Park        SE DECISION MADE: 11-SEP-17
Qingzhou  CN 255000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIOPHOTAS CELLUMA3
Biophotas Inc                     510(k) NO: K171323(Traditional)
ATTN: PATRICK  JOHNSON            PHONE NO : 714 8381956 
1000 E. Howell Ave. Ste A         SE DECISION MADE: 01-SEP-17
Anaheim CA  92805                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nanova Sealant
Nanova Biomaterials Inc           510(k) NO: K171330(Traditional)
ATTN: Andrew C. Ritts             PHONE NO : 573 8756682 
3806 Mojave Ct                    SE DECISION MADE: 08-SEP-17
Columbia MO  65202                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Indego
Parker Hannifin Corporation       510(k) NO: K171334(Traditional)
ATTN: Achilleas  Dorotheou        PHONE NO : 216 8962044 
1390 E. Highland Road             SE DECISION MADE: 08-SEP-17
Macedonia OH  44056               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Posterior Spine Truss System (PSTS) Interbody Fusion Device
4Web, Inc.                        510(k) NO: K171351(Traditional)
ATTN: Jessee  Hunt                PHONE NO : 800 2857090 
6170 REsearch Rd., Suite 219      SE DECISION MADE: 08-SEP-17
Frisco TX  75033                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Emprint SX Ablation Platform and Accessories
Coviden llc                       510(k) NO: K171358(Traditional)
ATTN: Patti  Arndt                PHONE NO : 303 5816668 
5920 Longbow Dr.                  SE DECISION MADE: 01-SEP-17
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pollogen Legend+ System
Pollogen Ltd.                     510(k) NO: K171359(Traditional)
ATTN: Ilana Dessow Lironne        PHONE NO : 972 3 5104110 
6 Kaufman St.                     SE DECISION MADE: 13-SEP-17
Tel Aviv  IL 6801298              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs
SEMPERIT INVESTMENTS ASIA PTE. LTD510(k) NO: K171378(Traditional)
ATTN: Clemens  Eichler            PHONE NO : 65 62 744861 
8 Jurong Town Hall Road, #29-03 ToSE DECISION MADE: 14-SEP-17
Singapore  SG                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carbon Monoxide Breath Sensor System (COBSS)
Carrot Sense, Inc.                510(k) NO: K171408(Traditional)
ATTN: Daniel J. Balbierz          PHONE NO : 650 5203259 
1600 Seaport Blvd, Suite 150      SE DECISION MADE: 29-SEP-17
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Berkeley VC-10 Vacuum Curettage System
Gyrus ACMI                        510(k) NO: K171440(Special)
ATTN: Christina  Flores           PHONE NO : 508 8042776 
136 Turnpike Rd                   SE DECISION MADE: 29-SEP-17
Southborough MA  01772            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exofin Fusion Skin Closure System
Chemence Medical, Inc.            510(k) NO: K171442(Abbreviated)
ATTN: Kenneth  Broadley           PHONE NO : 678 6890761 
200 Technology Drive              SE DECISION MADE: 25-SEP-17
Alpharetta GA  30005              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cefaly Acute
CEFALY Technology                 510(k) NO: K171446(Traditional)
ATTN: Jean-Yves  Mignolet         PHONE NO : 32 4 3676722 
Rue Louis Plescia 34              SE DECISION MADE: 15-SEP-17
Seraing  BE 4102                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder-free Clear Vinyl Patient Examination Gloves
Shandong Zhiwei Medical Products, 510(k) NO: K171460(Traditional)
ATTN: Carrie  Wu                  PHONE NO : 86 83 174088 
No. 4519 Qingzhou Road            SE DECISION MADE: 24-SEP-17
Qingzhou  CN 255000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASPIRE Bellus II
FUJIFILM Medical Systems U.S.A., I510(k) NO: K171463(Traditional)
ATTN: Jyh-Shyan  Lin              PHONE NO : 301 2511092 
419 West Avenue                   SE DECISION MADE: 29-SEP-17
Stamford CT  06902                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tritanium C Anterior Cervical Cage
STRYKER SPINE                     510(k) NO: K171496(Traditional)
ATTN: Deborah  Cynamon            PHONE NO : 201 7498388 
2 Pearl Court                     SE DECISION MADE: 06-SEP-17
Allendale NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Occlusion Detection Dressing Kit
Cardinal Health                   510(k) NO: K171499(Traditional)
ATTN: Beth  Foster                PHONE NO : 847 8872325 
1500 S Waukegan Rd                SE DECISION MADE: 22-SEP-17
Waukegan IL  60085                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CustomizedBone Service
Fin-ceramica faenza spa           510(k) NO: K171507(Traditional)
ATTN: Marina  Monticelli          PHONE NO : 0039 054 6607311 
via ravegnana 186                 SE DECISION MADE: 01-SEP-17
Faenza  IT 48018                  510(k) STATEMENT
                                                    

DEVICE: Footmotion Plating System
Newclip Technics                  510(k) NO: K171510(Special)
ATTN: Gaelle  Lussori             PHONE NO : 33 228 213712 
PA de la Lande Saint Martin - 45 rSE DECISION MADE: 08-SEP-17
Haute-Goulaine  FR 44 115         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FLXfit™
Expanding Orthopedics, Inc.       510(k) NO: K171519(Traditional)
ATTN: Ofer  Bokobza               PHONE NO : 404 4799926 
3379 Peachtree Road NE (Buckhead),SE DECISION MADE: 15-SEP-17
Atlanta GA  30326                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle
CareFusion                        510(k) NO: K171531(Traditional)
ATTN: Tamara  Brey                PHONE NO : 847 3629485 
75 North Fairway Drive            SE DECISION MADE: 11-SEP-17
Vernon Hills IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAPI 3 Hb A1c
Sebia                             510(k) NO: K171537(Traditional)
ATTN: Karen  Aderson              PHONE NO : 770 4463707 3704
1705 Corporate Drive Suite 400    SE DECISION MADE: 12-SEP-17
Norcross GA  30093                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves (Orange)
Comfort Rubber Gloves Industries S510(k) NO: K171541(Traditional)
ATTN: Chan Yew Men                PHONE NO : 605 8472777 
Lot 821, Jalan Matang             SE DECISION MADE: 20-SEP-17
Matang  MY 34750                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ExsoMed ITN Cannulated Screw System
Exsomed Holdings Company, LLC     510(k) NO: K171558(Traditional)
ATTN: Richard  Kovach             PHONE NO : 602 4663186 
7227 N 16th Street, Suite 245     SE DECISION MADE: 01-SEP-17
Phoenix AZ  85020                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NEO Pedicle Screw System™
Neo Medical S.A.                  510(k) NO: K171582(Traditional)
ATTN: Jonas  Larsson              PHONE NO : 41 225 483880 
Route de Lausanne 157A            SE DECISION MADE: 12-SEP-17
Villette (Lavaux)  CH 1096        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RhythmView Workstation
Abbott Electrophysiology          510(k) NO: K171583(Traditional)
ATTN: Dennis  Pozzo               PHONE NO : 214 3006580 
1530 Obrien Drive, Suite B        SE DECISION MADE: 01-SEP-17
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WiTouch Pro, WiTouch, Neubac
Hollywog LLC                      510(k) NO: K171599(Traditional)
ATTN: Michael  Treas              PHONE NO : 423 3057778 108
2830 Amnicola Highway             SE DECISION MADE: 22-SEP-17
Chattanooga TN  37406             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci Xi Surgical System
Intuitive Surgical, Inc           510(k) NO: K171632(Traditional)
ATTN: Brandon  Hansen             PHONE NO : 408 5232100 
1266 Kifer Road                   SE DECISION MADE: 19-SEP-17
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive TLX Interbody System
NuVasive, Incorporated            510(k) NO: K171633(Traditional)
ATTN: Cynthia  Adams              PHONE NO : 858 3204549 
7475 Lusk Blvd.                   SE DECISION MADE: 28-SEP-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BM.IRIS
Bluecore Co.,Ltd.                 510(k) NO: K171648(Traditional)
ATTN: Bill  Choi                  PHONE NO : 82 51 7474318 
Acehigh 21, 48 Centum-Jungang ro 1SE DECISION MADE: 08-SEP-17
Haeundae-gu  KR                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fresenius Liberty Select Cycler
Fresenius Medical Care Renal Thera510(k) NO: K171652(Traditional)
ATTN: Denise  Oppermann           PHONE NO : 781 6994479 
920 Winter Street                 SE DECISION MADE: 15-SEP-17
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Scopis Extended Instrument Set EM
Scopis GmbH                       510(k) NO: K171661(Traditional)
ATTN: Christopher  Özbek          PHONE NO : 49 302 0169380 
Heinrich-Heine-Platz 10           SE DECISION MADE: 27-SEP-17
Berlin  DE 10719                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
Bio-Rad Laboratories, Inc.        510(k) NO: K171664(Special)
ATTN: Sweta  Patel                PHONE NO : 510 7415157 
4000 Alfred Nobel Drive           SE DECISION MADE: 13-SEP-17
Hercules CA  94547                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Glove
Professional Latex Sdn Bhd        510(k) NO: K171667(Traditional)
ATTN: Yoon Lim Kok                PHONE NO : 605 89 11637 
Lot 52, Jalan Logam 2, Kamunting RSE DECISION MADE: 08-SEP-17
Kamunting  MY 34600               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Med4 Elite
Cool Systems, Inc. (dba Game Ready510(k) NO: K171685(Traditional)
ATTN: Natalie  Kennel             PHONE NO : 510 9845351 
1800 Sutter Street, Suite 500     SE DECISION MADE: 29-SEP-17
Concord CA  94520                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System
Choice Spine                      510(k) NO: K171686(Traditional)
ATTN: Kim  Finch                  PHONE NO : 865 2433375 
400 Erin Drive                    SE DECISION MADE: 15-SEP-17
Knoxville TN  37924               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Relieva SpinPlus Nav Balloon Sinuplasty System
Acclarent, Inc.                   510(k) NO: K171687(Traditional)
ATTN: James Patrick Garvey II     PHONE NO : 949 7898505 
33 Technology Drive               SE DECISION MADE: 05-SEP-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CuffLink Implant System
CONMED Corporation                510(k) NO: K171725(Traditional)
ATTN: Dionne  Sanders             PHONE NO : 727 3995564 
525 French Road                   SE DECISION MADE: 08-SEP-17
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LapBag
Sejong Medical Co., Ltd.          510(k) NO: K171726(Traditional)
ATTN: Yoojung  Choi               PHONE NO : 
11, Sinchon 2-ro                  SE DECISION MADE: 25-SEP-17
Paju-si  KR 10880                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm
Sterngold Dental, LLC             510(k) NO: K171728(Abbreviated)
ATTN: Maria  Rao                  PHONE NO : 508 2265660 
23 Frank Mossberg Drive           SE DECISION MADE: 28-SEP-17
Attleboro MA  02703               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FuckWater
Non-Friction Products Inc.        510(k) NO: K171730(Traditional)
ATTN: Marc  Barrette              PHONE NO : 416 8171745 
551 Church Street                 SE DECISION MADE: 07-SEP-17
Toronto  CA M4Y 2E2               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cobas Cdiff Nucleic acid test for use on the cobas Liat System
Roche Molecular Systems, Inc.     510(k) NO: K171770(Traditional)
ATTN: Clare  Santulli             PHONE NO : 925 7308886 
4300 Hacienda Drive               SE DECISION MADE: 12-SEP-17
Pleasanton CA  94588-2722         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WowGoHealth Blood Glucose Monitoring System
Biotest Medical Corporation       510(k) NO: K171785(Special)
ATTN: Fred  Lee                   PHONE NO : 886 4 25326668 413
No. 3-2, Chien-kuo Rd., TEPZ TantzSE DECISION MADE: 15-SEP-17
Taichung  TW 42760                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
Alere Scarborough, Inc.           510(k) NO: K171792(Traditional)
ATTN: Angela  Drysdale            PHONE NO : 207 4151393 
10 Southgate Road                 SE DECISION MADE: 29-SEP-17
Scarborough ME  04074             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thommen Implant System
Thommen Medical AG                510(k) NO: K171795(Traditional)
ATTN: Daniel  Snetivy             PHONE NO : 41 61 9659020 
Neckarsulmstrasse 28              SE DECISION MADE: 29-SEP-17
Grenchen  CH 2540                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zap-X Radiosurgery System
Zap Surgical Systems              510(k) NO: K171804(Traditional)
ATTN: Radhika Mohan Bodduluri     PHONE NO : 650 7965302 
590 Taylor Way Suite A            SE DECISION MADE: 21-SEP-17
San Carlos CA  94070              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml
ConceptoMed AS                    510(k) NO: K171805(Special)
ATTN: Marit  Martinsen            PHONE NO : 47 951 00720 
Hattvikveien 2                    SE DECISION MADE: 08-SEP-17
Ballstad  NO N-8373               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)
Biotest Medical Corporation       510(k) NO: K171822(Special)
ATTN: Fred  Lee                   PHONE NO : 866 4 25326668 413
No. 3-2, Chien-kuo Rd., TEPZ TantzSE DECISION MADE: 20-SEP-17
Taichung  TW 42760                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoNaut
Therenva SAS                      510(k) NO: K171829(Traditional)
ATTN: Matthis  HAMY               PHONE NO : 33 2 99283751 
4 rue Jean Jaures                 SE DECISION MADE: 21-SEP-17
Rennes  FR 35000                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Range/Denali/Mesa Spinal System
K2M, Inc.                         510(k) NO: K171832(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Parkway SE               SE DECISION MADE: 14-SEP-17
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Consolidated Operating Room Equipment (CORE) 2 Console
Stryker Corporation               510(k) NO: K171840(Traditional)
ATTN: Nicholas  Werner            PHONE NO : 269 3892971 
4100 E. Milham Ave.               SE DECISION MADE: 15-SEP-17
Kalamazoo MI  49001               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DARCO Locking Bone Plate System
Wright Medical Technology, Inc.   510(k) NO: K171852(Traditional)
ATTN: Val  Myles                  PHONE NO : 901 2905162 
1023 Cherry Road                  SE DECISION MADE: 21-SEP-17
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GALAXY G3 Mini Microcoil Delivery System
Codman & Shurtleff, Inc           510(k) NO: K171862(Traditional)
ATTN: Yoon Hee Beatty             PHONE NO : 305 2652919 
325 Paramount Drive               SE DECISION MADE: 25-SEP-17
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ceramill Zolid HT+ white
Amann Girrbach AG                 510(k) NO: K171876(Traditional)
ATTN: Debora  Engel               PHONE NO : 49 7231 957260 
Herrschaftswiesen 1               SE DECISION MADE: 20-SEP-17
Koblach  AT 6842                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZS3 Ultrasound System, z.one pro Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K171891(Traditional)
ATTN: Zhai  Pei                   PHONE NO : 86 075 581885604 
Mindray Building, Keji 12th Road SSE DECISION MADE: 21-SEP-17
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate)
Bluestone Synergy                 510(k) NO: K171893(Traditional)
ATTN: Lisa  Peterson              PHONE NO : 512 5070746 
5520 Ventana Ct.                  SE DECISION MADE: 08-SEP-17
Pueblo CO  81005                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive® Precept™ Spinal System
NuVasive, Incorporated            510(k) NO: K171894(Traditional)
ATTN: Marysa  Loustalot           PHONE NO : 858 3204515 
7475 Lusk Blvd.                   SE DECISION MADE: 28-SEP-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anatotemp Anatomic Dental Implant Healing Abutment
Buckeye Medical Technologies LLC  510(k) NO: K171922(Traditional)
ATTN: Terry B. Philibin           PHONE NO : 330 7199868 
405 Niles Cortland Rd SE Ste 202  SE DECISION MADE: 28-SEP-17
Warren OH  44484                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Peerbridge Cor(TM) System
Peerbridge Health INc.            510(k) NO: K171936(Third Party - Traditional)
ATTN: Arthur A. Bertolero         PHONE NO : 925 2602096 
1440 Broadway, 23rd Floor         SE DECISION MADE: 27-SEP-17
New York NY  10018                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: FreeStyle Precision Neo Blood Glucose Test Strips
Abbott Diabetes Care Inc.         510(k) NO: K171941(Traditional)
ATTN: Danielle  Tayor             PHONE NO : 510 2392674 
1360  South Loop Road             SE DECISION MADE: 27-SEP-17
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electrocardiograph
Edan Instruments, Inc.            510(k) NO: K171943(Traditional)
ATTN: Alice  Yang                 PHONE NO : 86 755 26858736 
#15 Jinhui Road,Jinsha Community, SE DECISION MADE: 25-SEP-17
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bard Mission Disposable Core Biopsy Instrument
Bard Peripheral Vascular, Inc.    510(k) NO: K171953(Third Party - Traditional)
ATTN: Susan  Sheffield            PHONE NO : 480 3506067 
1625 W 3rd St.                    SE DECISION MADE: 14-SEP-17
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes
Hologic, Inc.                     510(k) NO: K171963(Traditional)
ATTN: Ron  Domingo                PHONE NO : 858 4108167 
10210 Genetic Center Drive        SE DECISION MADE: 26-SEP-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LigaMetrics Suture Anchors
Mortise Medical LLC               510(k) NO: K171964(Traditional)
ATTN: Robert  Hoy                 PHONE NO : 614 4486358 
124 South 600 West, Suite 100     SE DECISION MADE: 19-SEP-17
Logan UT  84321                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Resection Electrodes with HF cable
Olympus Winter & Ibe GmbH         510(k) NO: K171965(Traditional)
ATTN: Jan-Oliver  Upmeier         PHONE NO : 49 406 69662098 
Kuehnstrasse 61                   SE DECISION MADE: 28-SEP-17
Hamburg  DE 22045                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterling Supreme Diode Laser
CAO Group, Inc.                   510(k) NO: K171986(Traditional)
ATTN: Robert K. Larsen            PHONE NO : 1 801 2569282 
4628 West Skyhawk Drive           SE DECISION MADE: 22-SEP-17
West Jordan UT  84084             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sculpsure
Cynosure, Inc                     510(k) NO: K171992(Traditional)
ATTN: Amy  Tannenbaum             PHONE NO : 781 9932454 
5 Carlisle Road                   SE DECISION MADE: 26-SEP-17
Westford MA  01886                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)
Careglove Global Sdn Bhd          510(k) NO: K172015(Traditional)
ATTN: Lim Kwee Shyan              PHONE NO : 60 6 6782377 
Lot 17479, Lrg Senawang 3/2, Off JSE DECISION MADE: 26-SEP-17
Seremban  MY 70450                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FluidSmart
THERMEDX, LLC                     510(k) NO: K172048(Special)
ATTN: Homer  Gregory              PHONE NO : 1 440 5420883 
31200 Solon Rd., Unit #1          SE DECISION MADE: 05-SEP-17
Solon OH  44139                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ti-Diagon Oblique TLIF
Camber Spine Technologies         510(k) NO: K172064(Traditional)
ATTN: Daniel  Pontecorvo          PHONE NO : 484 4277060 
418 E. Lancaster Avenue           SE DECISION MADE: 15-SEP-17
Wayne PA  19087                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SCARLET AC-T
SPINEART                          510(k) NO: K172065(Traditional)
ATTN: Franck  PENNESI             PHONE NO : 41 22 5701200 
3 chemin du pre Fleuri            SE DECISION MADE: 29-SEP-17
Plan Les Ouates  CH 1228          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Photoelectric Therapy System
Xstrahl Ltd.                      510(k) NO: K172080(Traditional)
ATTN: Andrew  Mullen              PHONE NO : 11 44 1543688920 
Unit 2 Maybrook Industrial Estate,SE DECISION MADE: 29-SEP-17
Brownhills  GB WS8 7DG            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: S60 Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp.           510(k) NO: K172082(Traditional)
ATTN: Toki  Wu                    PHONE NO : 86 755 26722890 
4/f, 5/f, 8/f, 9/f & 10/f Yizhe buSE DECISION MADE: 21-SEP-17
Shenzhen  CN 518051               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Matira™ Anterior Cervical System
Kalitec Direct, LLC               510(k) NO: K172086(Traditional)
ATTN: Keith  Cannan               PHONE NO : 407 5452063 103
618 E. South Street, Suite 500    SE DECISION MADE: 22-SEP-17
Orlando FL  32801                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ROMEO® 2 Posterior Osteosynthesis System
Spineart                          510(k) NO: K172101(Traditional)
ATTN: Franck  Pennesi             PHONE NO : 41 22 5701200 
3 chemin du pre Fleuri            SE DECISION MADE: 26-SEP-17
Plan Les Ouates  CH 1228          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL
Liofilchem s. r. l.               510(k) NO: K172109(Traditional)
ATTN: Fabio  Brocco               PHONE NO : 39  0858930745 
Via Scozia zona ind.le            SE DECISION MADE: 27-SEP-17
Roseto degli Abruzzi  IT 64026    510(k) STATEMENT
                                                    

DEVICE: Prelude Pursuit Splittable Sheath Introducer
Merit Medical Systems, Inc.       510(k) NO: K172117(Traditional)
ATTN: Jacquelyn  Huyghue          PHONE NO : 610 6515090 
65 Great Valley Parkway           SE DECISION MADE: 11-SEP-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Veress Needle
WickiMed (Huizhou) Medical Equipme510(k) NO: K172120(Traditional)
ATTN: Haobin  Li                  PHONE NO : 0086 0752 3860807 
Tang Jiao Wang Street, Lilin Town,SE DECISION MADE: 14-SEP-17
Huizhou  CN 516000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xpert Xpress Strep A
Cepheid                           510(k) NO: K172126(Traditional)
ATTN: Yi-Ping  Lin                PHONE NO : 408 4006838 
904 Caribbean Drive               SE DECISION MADE: 25-SEP-17
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FibroScan 430 Mini+
Echosens                          510(k) NO: K172142(Traditional)
ATTN: Karine  Bonenfant           PHONE NO : 33 144 827856 
30 Place d'Italie                 SE DECISION MADE: 13-SEP-17
Paris  FR 75013                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)
bioMerieux, Inc                   510(k) NO: K172150(Traditional)
ATTN: Cherece L. Jones            PHONE NO : 314 7318684 
595 Anglum Rd.                    SE DECISION MADE: 15-SEP-17
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: APTUS(R) Wrist 2.5 System
Medartis AG                       510(k) NO: K172170(Traditional)
ATTN: Andrea  Schweizer           PHONE NO : 41 61 6333434 
Hochbergerstrasse 60E             SE DECISION MADE: 08-SEP-17
Basel  CH CH-4057                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECOM™ Cardiac Output Monitoring System
ECOM Medical, Inc                 510(k) NO: K172196(Traditional)
ATTN: Guy  Lowery                 PHONE NO : 1 949 4291390 
27127 Calle Arroyo, Suite 1905    SE DECISION MADE: 19-SEP-17
San Juan Capistrano CA  92675     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
Medtronic Sofamor Danek           510(k) NO: K172199(Traditional)
ATTN: Justin  O'Connor            PHONE NO : 901 3463133 
1800 Pyramid Place                SE DECISION MADE: 19-SEP-17
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mako Total Knee Application
MAKO Surgical Corp.               510(k) NO: K172219(Traditional)
ATTN: Karen  Ariemma              PHONE NO : 201 8315718 
2555 Davie Road                   SE DECISION MADE: 21-SEP-17
Fort Lauderdale FL  33317         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Magic3 Go Intermittent Urinary Catheter
C.R. Bard, Inc.                   510(k) NO: K172247(Traditional)
ATTN: Nancy  Underwood            PHONE NO : 770 7846284 
8195 Industrial Blvd              SE DECISION MADE: 20-SEP-17
Covington GA  30014               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitality® Spinal Fixation System, Vitality®+ Power Instrument System
Zimmer Biomet Spine, Inc.         510(k) NO: K172275(Traditional)
ATTN: Kelly  Stratton             PHONE NO : 303 5018386 
10225 Westmoor Drive              SE DECISION MADE: 27-SEP-17
Westminster CO  80021             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PMT Posterior Fixation System
Providence Medical Technology, Inc510(k) NO: K172279(Traditional)
ATTN: Edward  Liou                PHONE NO : 1 415 9239376 
1331 N. California Blvd. Suite 320SE DECISION MADE: 20-SEP-17
Walnut Creek CA  94596            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Accordion Piccolo Stone Management Device
THS International, Inc. d/b/a Acco510(k) NO: K172299(Special)
ATTN: David  Quigley              PHONE NO : 317 7592869 
9465 Counselors Row, Suite 200    SE DECISION MADE: 19-SEP-17
Indianapolis IN  46240            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoscopic Ultrasound Aspiration Needle
Micro-Tech (Nanjing) CO.,Ltd.     510(k) NO: K172309(Traditional)
ATTN: Becky  Li                   PHONE NO : 86 25 58646378 
No. 10 Gaoke Third Road           SE DECISION MADE: 29-SEP-17
Nanjing  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
Art Optical Contact Lens Inc      510(k) NO: K172314(Traditional)
ATTN: Mike  Johnson               PHONE NO : 616 5595167 
3175 3 Mile Rd NW                 SE DECISION MADE: 20-SEP-17
Grand Rapids MI  49534            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Voluson E6, Voluson E8, Voluson E10
GE Healthcare                     510(k) NO: K172342(Traditional)
ATTN: Bryan  Behn                 PHONE NO : 414 7214214 
9900 Innovation Drive, Milwaukee CSE DECISION MADE: 29-SEP-17
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BladderScan Prime PLUS System
Verathon Incorporated             510(k) NO: K172356(Third Party - Traditional)
ATTN: Swapna  Chirala             PHONE NO : 425 6295582 
20001 North Creek Parkway         SE DECISION MADE: 15-SEP-17
Bothell WA  98011                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: QuadraSphere Microspheres
Biosphere Medical, S.A.           510(k) NO: K172372(Special)
ATTN: Alix  Fonlladosa            PHONE NO : 33 1 48172529 
Parc des Nations – Paris Nord 2, 3SE DECISION MADE: 06-SEP-17
Roissy en France  FR 95700        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MicroSTAAR Injector System Cartridges
STAAR Surgical Company            510(k) NO: K172375(Special)
ATTN: Kate  Ueda                  PHONE NO : 626 3037902 2316
1911 Walker Avenue                SE DECISION MADE: 06-SEP-17
Monrovia CA  91016                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: U2 Diagnostic Ultrasound System
Edan Instruments Inc              510(k) NO: K172380(Traditional)
ATTN: Alice  Yang                 PHONE NO : 86 7552 6858736 
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 29-SEP-17
Shenzhen  CN 518067               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clarius Ultrasound System
Clarius Mobile Health Corp.       510(k) NO: K172385(Third Party - Abbreviated)
ATTN: Abhijit  Ahir               PHONE NO : 778 2609975 
350 - 3605 Gilmore Way            SE DECISION MADE: 14-SEP-17
Burnaby  CA V5G 4X5               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Steerable Guide Catheter
Abbott Vascular                   510(k) NO: K172394(Special)
ATTN: Makena  Mc Gowan            PHONE NO : 408 8450937 
3200 Lakeside Drive               SE DECISION MADE: 06-SEP-17
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sherlock 3CG Tip Positioning System Stylet
C.R. Bard, Inc.                   510(k) NO: K172397(Special)
ATTN: Mona  Shahrebani            PHONE NO : 1 801 5225967 
605 North 5600 West               SE DECISION MADE: 29-SEP-17
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
Wear Safe (Malaysia) Sdn. Bhd.    510(k) NO: K172420(Traditional)
ATTN: Cho Sow Fong                PHONE NO : 603 3392 1388 1328
LOT 5068 & 5069, BATU 4 1/2, JALANSE DECISION MADE: 29-SEP-17
Klang  MY 41050                   510(k) STATEMENT
                                                    

DEVICE: NICO BrainPath
NICO Corporation                  510(k) NO: K172433(Special)
ATTN: Sean  Spence                PHONE NO : 317 6607118 
250 E 96TH St. Suite 125          SE DECISION MADE: 07-SEP-17
Indianapolis IN  46240            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amsel Occluder Device
Amsel Medical                     510(k) NO: K172479(Special)
ATTN: Raanan  Miller              PHONE NO : 617 3082304 
171 Hamilton Street               SE DECISION MADE: 14-SEP-17
Cambridge MA  02139               510(k) STATEMENT
                                                    

DEVICE: IntelliCart System
Dornoch Medical Systems           510(k) NO: K172481(Special)
ATTN: Larry  Smith                PHONE NO : 816 5954416 
200 North West Parkway            SE DECISION MADE: 14-SEP-17
Riverside MO  64150               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle
Anexa Biomedical, Inc.            510(k) NO: K172486(Traditional)
ATTN: Lenny  Budloo               PHONE NO : 813 7807927 
40423 Air Time Avenue             SE DECISION MADE: 21-SEP-17
Zephyrhills FL  33542             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reliance Cervical IBF System
Reliance Medical Systems, LLC     510(k) NO: K172489(Special)
ATTN: Bret M. Berry               PHONE NO : 801 2953280 
545 West 500 South, Suite 100     SE DECISION MADE: 07-SEP-17
Bountiful UT  84010               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iNSitu Total Hip System
Theken Companies, LLC             510(k) NO: K172501(Special)
ATTN: Dale  Davison               PHONE NO : 330 7337600 
1800 Triplett Blvd                SE DECISION MADE: 21-SEP-17
Akron OH  44306                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Cathena Safety IV Catheter
Becton, Dickinson and Company     510(k) NO: K172506(Third Party - Traditional)
ATTN: Henry  Boland               PHONE NO : 801 5652300 
9450 South State Street           SE DECISION MADE: 17-SEP-17
Sandy UT  84070                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 3D Echo
JointVue LLC                      510(k) NO: K172513(Third Party - Traditional)
ATTN: Mohamed R. Mahfouz          PHONE NO : 877 7256920 101
2099 Thunderhead Rd., Suite 104   SE DECISION MADE: 14-SEP-17
Knoxville TN  37922               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited    510(k) NO: K172519(Special)
ATTN: Samantha  Neilson           PHONE NO : 44 1482 673790 
101 Hessle Road                   SE DECISION MADE: 15-SEP-17
Hull  GB HU3 2BN                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited    510(k) NO: K172521(Special)
ATTN: Samantha  Neilson           PHONE NO : 44 1482 673790 
101 Hessle Road                   SE DECISION MADE: 20-SEP-17
Hull  GB HU3 2BN                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mazor X
Mazor Robotics Ltd.               510(k) NO: K172522(Special)
ATTN: Shiran  Conforti            PHONE NO : 972 4 6187100 
5 Shacham St. North Industrial ParSE DECISION MADE: 15-SEP-17
Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IV Fat Emulsion Administration Sets
Baxter Healthcare Corporation     510(k) NO: K172544(Special)
ATTN: Jill M. Laack               PHONE NO : 224 2702686 
32650 N. Wilson Road              SE DECISION MADE: 22-SEP-17
Round Lake IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SERI Contour
Sofregen Medical, Inc.            510(k) NO: K172545(Special)
ATTN: Anh  Hoang                  PHONE NO : 781 8742352 
200 Boston Avenue, Suite 1100     SE DECISION MADE: 22-SEP-17
Medford MA  02155                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
Hologic, Inc.                     510(k) NO: K172566(Special)
ATTN: Catherine  Sanford          PHONE NO : 508 2638604 
250 Campus Drive                  SE DECISION MADE: 20-SEP-17
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ULTRASCORE Focused Force PTA Balloon
C.R. Bard                         510(k) NO: K172571(Special)
ATTN: Jonathan  Holmes            PHONE NO : 480 3506161 
1625 W 3rd St                     SE DECISION MADE: 22-SEP-17
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CareView 1800Cw X-ray Flat Panel Detectors
CareRay Digital Medical System Co.510(k) NO: K172581(Special)
ATTN: Xu  Wei                     PHONE NO : 86 5128 6860288109 
B3-501, Biobay, 218 Xinghu Street,SE DECISION MADE: 26-SEP-17
SuZhou  CN 215123                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers
Medacta International SA          510(k) NO: K172587(Special)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 18-SEP-17
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CUSA Excel+ Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation  510(k) NO: K172595(Special)
ATTN: Alexandra  Wells            PHONE NO : 609 7507872 
311 Enterprise Drive              SE DECISION MADE: 28-SEP-17
PLAINSBORO NJ  08536              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FiberTak DX
Arthex, Inc                       510(k) NO: K172612(Special)
ATTN: Ivette  Galmez              PHONE NO : 239 6435553 71263
1370 Creekside Boulevard          SE DECISION MADE: 28-SEP-17
Naples FL  34108                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRECICE System
NuVasive Specialized Orthopedics, 510(k) NO: K172628(Traditional)
ATTN: Cora  Sim                   PHONE NO : 949 5446478 
101 Enterprise, Suite 100         SE DECISION MADE: 25-SEP-17
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arisure Dry Spike
Yukon Medical                     510(k) NO: K172631(Third Party - Traditional)
ATTN: Todd  Korogi                PHONE NO : 919 5958250 
4021 Stirrup Creek Dr. Suite #200 SE DECISION MADE: 29-SEP-17
Durham NC  27703                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture
M/s. Meril Endo Surgery Private Li510(k) NO: K172659(Special)
ATTN: Umesh  Sharma               PHONE NO : 91 0260 3052100 
Third Floor, E1-E3, Meril Park SurSE DECISION MADE: 28-SEP-17
Chala, Vapi  IN 396191            510(k) SUMMARY AVAILABLE FROM FDA
                                                    


   TOTAL 510(k)s THIS PERIOD   246                                     
   TOTAL WITH SUMMARIES        236                                     
   TOTAL WITH STATEMENTS        10