Medical Devices

July 2015 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD July 2015
 
 
DEVICE: TRANSONIC TISSUE PERFUSION MONITOR
TRANSONIC SYSTEMS, INC.           510(k) NO: K140740(Traditional)
ATTN: DAVID  KLEMENTOWSKI         PHONE NO : 607 257-5300 
34 DUTCH MILL RD.                 SE DECISION MADE: 23-JUL-15
ITHACA NY  14850                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AUTOMATIC BLOOD PRESSURE MONITOR
JAWON MEDICAL CO., LTD.           510(k) NO: K140762(Traditional)
ATTN: WOO S PARK                  PHONE NO : 822 626 49001 
LIFE-OFFICETEL 320,40,63-RO YOUNGDSE DECISION MADE: 02-JUL-15
SEOUL  KR 150-731                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin
BIOMERIEUX                        510(k) NO: K141133(Traditional)
ATTN: JOHN  ALBRIGHT              PHONE NO : 314 731-8546 
595 ANGLUM ROAD                   SE DECISION MADE: 09-JUL-15
HAZELWOOD MO  63042-2320          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS
TECO DIAGNOSTICS                  510(k) NO: K141289(Traditional)
ATTN: AQUIL  MERCHANT             PHONE NO : 714 463-1111 
1268 NORTH LAKEVIEW AVE.          SE DECISION MADE: 24-JUL-15
ANAHEIM CA  92807                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST
ACCUMETRICS, INC.                 510(k) NO: K141427(Traditional)
ATTN: FRANK M LADUCA              PHONE NO : 858 643-1600 
3985 SORRENTO VALLEY BLVD. SUITE BSE DECISION MADE: 24-JUL-15
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: iuStar300 Medical Ultrasound Diagnostic System
UNITED IMAGING SYSTEMS (BEIJING) C510(k) NO: K141720(Traditional)
ATTN: JUN  PENG                   PHONE NO : 305 609-4701 
6840 SW 45TH LN UNIT 5            SE DECISION MADE: 23-JUL-15
MIAMI FL  33155                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BONGOLD BONE GRAFT MATERIAL
BEIJING ALLGENS MEDICAL SCIENCE & 510(k) NO: K141725(Traditional)
ATTN: HELEN  CUI                  PHONE NO : 908 392-4742 
7 LIBERTY RIDGE ROAD              SE DECISION MADE: 09-JUL-15
BASKING RIDGE NJ  07920           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NEODENT IMPLANT SYSTEM
JJGC INDUSTRIA E COMERCIO DE MATER510(k) NO: K141777(Traditional)
ATTN: KEVIN A THOMAS              PHONE NO : 858 792-1235 
12264 EL CAMINO REAL, STE 400     SE DECISION MADE: 20-JUL-15
SAN DIEGO CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT
CAREFUSION                        510(k) NO: K141965(Traditional)
ATTN: JOY  GREIDANUS              PHONE NO : 847 362-8103 
75 NORTH FAIRWAY DRIVE            SE DECISION MADE: 02-JUL-15
VERNON HILLS IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DIGITEK TITANIUM ABUTMENT
DIGITEK DENTAL SOLUTIONS LIMITED  510(k) NO: K141970(Traditional)
ATTN: ALWIN  NGAI                 PHONE NO : 852 2742 3210 
93 KINGLAM ST, CHEUNG SHA WAN UNITSE DECISION MADE: 31-JUL-15
KOWLOON, HONG KONG  CN 999077     510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SpineFab Vertebral Body Replacement (VBR) System
OXFORD PERFORMANCE MATERIALS      510(k) NO: K142005(Traditional)
ATTN: LEIGH  AYRES                PHONE NO : 860 698-9300 
30 S SATELLITE ROAD               SE DECISION MADE: 10-JUL-15
SOUTH WINDSOR CT  06074           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OCS-B COLLAGEN
NIBEC CO LTD                      510(k) NO: K142040(Traditional)
ATTN: DANIEL  NAM                 PHONE NO : 213 626-1544 
904 E. WINDSOR ROAD #102          SE DECISION MADE: 31-JUL-15
GLENDALE CA  91203                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET
BIOPHOR DIAGNOSTICS, INC.         510(k) NO: K142129(Traditional)
ATTN: NATAHANIEL G BUTLIN         PHONE NO : 650 367-4954 
1201 DOUGLAS AVE                  SE DECISION MADE: 24-JUL-15
REDWOOD CITY CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove
PT MEDISAFE TECHNOLOGIES          510(k) NO: K142190(Traditional)
ATTN: Anil  Taneja                PHONE NO : 62 61 30007134 
JI BANTANG KUIS. GG TAMBAK REJO PASE DECISION MADE: 14-JUL-15
TANJUNG MORAWA, MEDAN  ID 20362   510(k) STATEMENT
                                                    
 
DEVICE: Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow
Ellex Medical Pty. Ltd.           510(k) NO: K142398(Traditional)
ATTN: KEVIN  HOWARD               PHONE NO : 61 8 81045200 
82 GILBERT ST.                    SE DECISION MADE: 14-JUL-15
ADELAIDE  AU 5000                 510(k) STATEMENT
                                                    
 
DEVICE: Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System
CARDIAC INSIGHT, INC.             510(k) NO: K142468(Traditional)
ATTN: BRAD  HARLOW                PHONE NO : 425 8182175 
2815 EASTLAKE AVE. E., STE#300    SE DECISION MADE: 11-JUL-15
SEATTLE WA  98102                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: The Moses Express appliance
ALLEN J. MOSES, DDS, LTD.         510(k) NO: K142651(Traditional)
ATTN: ALLEN J. MOSES, DDS         PHONE NO : 1 312 9930430 
233 S. WACKER DR.                 SE DECISION MADE: 17-JUL-15
CHICAGO IL  60606                 510(k) STATEMENT
                                                    
 
DEVICE: LeadCare Plus Blood Lead Testing System
Magellan Diagnostics              510(k) NO: K142705(Traditional)
ATTN: Reba  Daoust                PHONE NO : 978 2484811 
101 Billerica Ave. Bldg #4        SE DECISION MADE: 07-JUL-15
North Billerica MA  01862         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: O Glide Personal Lubricant
Grafenberg Labs                   510(k) NO: K142726(Traditional)
ATTN: Manny  Frankl               PHONE NO : 212 7966565 
755 Second Avenue                 SE DECISION MADE: 24-JUL-15
New York NY  10017                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: KYOLING CPR Mask with Oxygen Port and Without Oxygen Port
HANGZHOU JINLIN MEDICAL APPLIANCES510(k) NO: K142764(Traditional)
ATTN: Lydia  HE                   PHONE NO : 86 571869 11905 
No. 9 16TH AVE HANGZHOU ECONOMIC &SE DECISION MADE: 09-JUL-15
HANGZHOU   CN 310018              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OneTouch Lubricant Gel
THAI NIPPON RUBBER INDUSTRY CO., L510(k) NO: K142790(Traditional)
ATTN: Pisut  Chanwatarungkull     PHONE NO : 66 38317 999 
789/139 Pinthong Industrial EstateSE DECISION MADE: 30-JUL-15
Sriracha  TH 20110                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Model BT-220L and BT-220C
Bistos Co., Ltd.                  510(k) NO: K142799(Traditional)
ATTN: Young  Chi                  PHONE NO : 973 2785222 
27 New England Drive              SE DECISION MADE: 09-JUL-15
Ramsey NJ  07446                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Biogensis Implant System-Kisses
BIOGENESIS CO., LTD.              510(k) NO: K142813(Traditional)
ATTN: Haeyong  Lee                PHONE NO : 82 55 6070345 
Mecha Zone #1109, SK Techno Park,5SE DECISION MADE: 31-JUL-15
Changwon-Si  KR 642-971           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set
COOK INCORPORATED                 510(k) NO: K142819(Traditional)
ATTN: STEVEN   LAWRIE             PHONE NO : 812 3353575 104518
750 DANIELS WAY P.O. BOX 489      SE DECISION MADE: 24-JUL-15
BLOOMINGTON IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Visi Mobile Monitoring System, Visi Mobile Chest Sensor
Sotera Wireless, Inc.             510(k) NO: K142827(Abbreviated)
ATTN: Eben  Gordon                PHONE NO : 1 858 3734841 
10020 Huennekens Street           SE DECISION MADE: 20-JUL-15
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification;
Cook Incorporated                 510(k) NO: K142829(Traditional)
ATTN: Sarah  Reeves               PHONE NO : 1 812 3353575 105024
750 Daniels Way P.O. Box 489      SE DECISION MADE: 28-JUL-15
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SILKPRO laser hair removal system
Wuhan Lotuxs Technology Co., Ltd  510(k) NO: K142845(Traditional)
ATTN: Wu  Na                      PHONE NO : 86 278761 9668 
No. 666 High-tec Ave. East Lake HiSE DECISION MADE: 01-JUL-15
Wuhan  CN 430075                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA)
Omega Laboratories, Inc.          510(k) NO: K142855(Traditional)
ATTN: William  Corl               PHONE NO : 1 330 6285748 
400 N. Cleveland Ave.             SE DECISION MADE: 28-JUL-15
Mogadore OH  44260                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PROTOCOL Incision Dressing
DEROYAL INDUSTRIES                510(k) NO: K142962(Traditional)
ATTN: Elizabeth  Wheeler          PHONE NO : 865 3622333 
200 DEBUSK LANE                   SE DECISION MADE: 23-JUL-15
POWELL TN  37849                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Virtuoso System for IHC PR (1E2) using iScan HT
Ventana Medical Systems, Inc.     510(k) NO: K142965(Traditional)
ATTN: Morteza  Minaee             PHONE NO : 1 408 2074201 
203 Ravendale Drive               SE DECISION MADE: 16-JUL-15
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SterilContainer S System
AESCULAP, INC.                    510(k) NO: K142970(Traditional)
ATTN: Denise R Adams              PHONE NO : 1 610 9849076 
3773 Corporate Parkway            SE DECISION MADE: 08-JUL-15
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Implant, Endosseous, Root-Form and Endosseous dental implant abutment
Implant Direct Sybron Manufacturin510(k) NO: K143011(Traditional)
ATTN: Ines  Aravena               PHONE NO : 818 4443347 
3050 East Hillcrest Drive         SE DECISION MADE: 16-JUL-15
Thousand Oaks CA  91362           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: mcompass Biofeedback Anorectal Manometry System
MEDSPIRA, LLC                     510(k) NO: K143031(Traditional)
ATTN: JIM  QUACKENBUSH            PHONE NO : 1 612 7890013 
2718 SUMMER STREET NE             SE DECISION MADE: 07-JUL-15
MINNEAPOLIS MN  55413             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DENTCA DENTURE BASE
DENTCA, INC.                      510(k) NO: K143033(Traditional)
ATTN: Jason   Lee                 PHONE NO : 1 323 2327505 
3608 Griffith Avenue              SE DECISION MADE: 21-JUL-15
Los Angeles CA  90011             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Disposable Safety Self-destructive Syringes, 5 ML
Jiangsu Yile Medical Article Co.,L510(k) NO: K143070(Traditional)
ATTN: Feng  Xingyuan              PHONE NO : 86 519 88675299 
Sanhekou Development Zone         SE DECISION MADE: 07-JUL-15
Changzhou City  CN 213115         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set
TOSOH BIOSCIENCE, INC.            510(k) NO: K143075(Traditional)
ATTN: ROBERT  L WICK              PHONE NO : 650 6368117 
6000 SHORELINE COURT SUITE 101    SE DECISION MADE: 02-JUL-15
SOUTH SAN FRANCISCO CA  94080     510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: IV Administration Sets with 200(micro)m Blood Filter
B. Braun Medical Inc.             510(k) NO: K143082(Traditional)
ATTN: Angela J Caravella          PHONE NO : 610 5962966 
901 Marcon Blvd                   SE DECISION MADE: 24-JUL-15
Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions
Arrow International, Inc.  (Subsid510(k) NO: K143102(Traditional)
ATTN: Debra  Grodt                PHONE NO : 610 3780131 
2400 Bernville Road               SE DECISION MADE: 24-JUL-15
Reading PA  19605                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PROPENCIL Smoke Pencil
BIO PROTECH, INC.                 510(k) NO: K143103(Traditional)
ATTN: Terry  Kim                  PHONE NO : 82 33 7357720 
Donghwa Medical Instrument ComplexSE DECISION MADE: 16-JUL-15
Wonju-si  KR 220-801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: The VersaJet II Hydrosurgery System
SMITH & NEPHEW, INC.              510(k) NO: K143115(Traditional)
ATTN: Laura  Reynolds             PHONE NO : 1 727 3297702 
970 LAKE CARILLON DRIVE SUITE 110 SE DECISION MADE: 15-JUL-15
ST. PETERSBURG FL  33716          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OrthoPulse
BIOLUX RESEARCH LTD.              510(k) NO: K143120(Traditional)
ATTN: Kevin  Strange              PHONE NO : 1 604 6690674 
825 POWELL STREET, SUITE 220      SE DECISION MADE: 24-JUL-15
VANCOUVER  CA V6A 1H7             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device
SMITH & NEPHEW, INC.              510(k) NO: K143133(Traditional)
ATTN: LAURA  REYNOLDS             PHONE NO : 1 727 3997702 
970 LAKE CARILLON DRIVE SUITE 110 SE DECISION MADE: 23-JUL-15
ST. PETERSBURG FL  33716          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PATHWAY ELIF
CUSTOM SPINE, INC.                510(k) NO: K143143(Traditional)
ATTN: Mahmoud  Abdelgany          PHONE NO : 862 8126107 
9 CAMPUS DR.                      SE DECISION MADE: 22-JUL-15
PARSIPPANY NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: TM-ABI system
LD TECHNOLOGY LLC                 510(k) NO: K143152(Traditional)
ATTN: Albert  Maarek              PHONE NO : 305 3799900 
100 N. Biscayne Blvd., Suite 502  SE DECISION MADE: 22-JUL-15
Miami FL  33132                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: UltraLinq
ULTRALINQ HEALTHCARE SOLUTIONS, IN510(k) NO: K143176(Traditional)
ATTN: Stephen  Farber             PHONE NO : 646 6669576 
236 West 30th Street, 15th Floor  SE DECISION MADE: 17-JUL-15
New York NY  10001                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters
BOSTON SCIENTIFIC                 510(k) NO: K143193(Traditional)
ATTN: Anna  Deraney               PHONE NO : 1 763 4941683 
ONE SCIMED PLACE                  SE DECISION MADE: 24-JUL-15
MAPLE GROVE MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ANGIO-PRESS DVT Compression Device Model Name: IPCS
Pegasus Medical Supply, Inc.      510(k) NO: K143202(Traditional)
ATTN: PAO-MING   SHIH             PHONE NO : 886 3 2753341 
No. 27-1, Ln. 473, Sec. 2, Hezun NSE DECISION MADE: 07-JUL-15
Taoyuan County  TW 32060          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: INOmax DSIR Plus MRI
INO Therapeutics/Ikaria           510(k) NO: K143213(Traditional)
ATTN: Robert  Bovy                PHONE NO : 1 608 2263450 
6603 Femrite Drive                SE DECISION MADE: 10-JUL-15
Madison WI  53718                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NIRO-200NX
Hamamatsu Photonics K.K.          510(k) NO: K143219(Traditional)
ATTN: SUSUMU  SUZUKI              PHONE NO : 81 53 4310124 
812 Joko-cho Highashi-ku          SE DECISION MADE: 31-JUL-15
Hamamatsu City  JP 431-3196       510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Magellan Robotic System, Magellan Robotic Catheter 10Fr
HANSEN MEDICAL, INC.              510(k) NO: K143227(Traditional)
ATTN: TODD  MILHOLLAND            PHONE NO : 1 650 4042777 
800 E. MIDDLEFIELD ROAD           SE DECISION MADE: 01-JUL-15
MOUNTAIN VIEW CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Theranos Herpes Simplex Virus-1 IgG Assay
THERANOS, INC.                    510(k) NO: K143236(Traditional)
ATTN: Brad  Arington              PHONE NO : 1 650 8567304 
1701 PAGE MILL ROAD               SE DECISION MADE: 02-JUL-15
PALO ALTO CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: TENS AND POWERED MUSCLE STIMULATOR
SHENZHEN AS-TEC TECHNOLOGY CO., LT510(k) NO: K143268(Traditional)
ATTN: CONNIE  LI                  PHONE NO : 86 755 33276149 
2C XINGBAOYI INDUSTRIAL BLD., HOUTSE DECISION MADE: 21-JUL-15
SHENZHEN  CN 518104               510(k) STATEMENT
                                                    
 
DEVICE: CastleLoc-P Anterior Cervical Plate System
L&K BIOMED Co., Ltd               510(k) NO: K143271(Traditional)
ATTN: Ki-Hyang  Kim               PHONE NO : 82 707 6006064 
#201, 202 16-25, Dongbaekjungang-rSE DECISION MADE: 01-JUL-15
Giheung-gu, Yongin-si  KR 446-916 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: IOLMaster700
Carl Zeiss Meditec, Inc.          510(k) NO: K143275(Traditional)
ATTN: Christine  Dunbar           PHONE NO : 925 560 5139 
5160 Hacienda Drive               SE DECISION MADE: 10-JUL-15
Dublin CA  94568-7562             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile),
Lifestyle Safety Products (Hui Zho510(k) NO: K143277(Traditional)
ATTN: Lee Hong Chong              PHONE NO : 0086 0752 6863042 
Daxiaotang Village, Luoyang Town, SE DECISION MADE: 29-JUL-15
Hui Zhou City  CN 516120          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LnK Posterior Cervical Fixation System
L&K BIOMED Co., Ltd.              510(k) NO: K143278(Traditional)
ATTN: An  Yerim                   PHONE NO : 82 2 67171985 
#201,202 16-25 Dongbaekjungang-ro SE DECISION MADE: 29-JUL-15
Giheung-gu,Yongin-si  KR 446-916  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Medline Natural Lubricating Liquid
MEDLINE INDUSTRIES, INC.          510(k) NO: K143322(Traditional)
ATTN: JENNIFER  MASON             PHONE NO : 847 6433652 
ONE MEDLINE PLACE                 SE DECISION MADE: 20-JUL-15
MUNDLELEIN IL  60060              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Powder Free Vinyl Patient Examination Gloves, Yellow Color
Zibo Ling Yun Medical Products Co,510(k) NO: K143340(Traditional)
ATTN: Eric  Wang                  PHONE NO : 86 368 5330127 
No. 318 Yuming Road Zibo IndustriaSE DECISION MADE: 09-JUL-15
Zibo  CN 255400                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SIGNA Pioneer
GE HEALTHCARE JAPAN CORPORATION   510(k) NO: K143345(Traditional)
ATTN: Toru  Shimizu               PHONE NO : 81 42 5855344 
7-127, Asahigaoka 4-chome         SE DECISION MADE: 10-JUL-15
HINO-SHI  JP 191-8503             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Powder-Free White Vinyl Patient Examination Gloves
Zibo Changda Plastic Products Comp510(k) NO: K143346(Traditional)
ATTN: Coco  Kou                   PHONE NO : 86 533 3819144 
Yumin Road                        SE DECISION MADE: 22-JUL-15
Zibo  CN 255000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Powder-Free Yellow Vinyl Patient Examination Gloves
Zibo Zhouheng Plastic Products Co.510(k) NO: K143347(Traditional)
ATTN: Cherry  Xu                  PHONE NO : 86 533 3819122 
Sanying Road                      SE DECISION MADE: 24-JUL-15
Zibo  CN 255087                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: The Simple Locking IntraMedullary (SLIM) System
PEGA MEDICAL INC.                 510(k) NO: K143355(Traditional)
ATTN: Ariel R Dujovne             PHONE NO : 450 6885144 
1111 AUTOROUTE CHOMEDEY           SE DECISION MADE: 10-JUL-15
LAVAL  CA H7W 5J8                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NovoStitch Plus Meniscal Repair System
Ceterix Orthopaedics, Inc.        510(k) NO: K143356(Traditional)
ATTN: Michael  Hendricksen        PHONE NO : 650 3168660 
959 Hamilton Ave                  SE DECISION MADE: 21-JUL-15
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GenIQ
GE MEDICAL SYSTEMS, LLC.          510(k) NO: K143368(Traditional)
ATTN: Jenny  Wong                 PHONE NO : 262 5482899 
3200 N. GRANDVIEW BLVD            SE DECISION MADE: 29-JUL-15
WAUKESHA WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Q6 Edge EM
Pride Mobility Product Corporation510(k) NO: K143383(Traditional)
ATTN: Kimberly  Elmes             PHONE NO : 570 6555574 
182 Susquehanna Avenue            SE DECISION MADE: 23-JUL-15
Exeter PA  18643                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: STRONG Dental Handpieces
Saeshin Precision Co., Ltd.       510(k) NO: K143418(Traditional)
ATTN: Choi  Sae Kwan              PHONE NO : 82 53 5800984 
52, Secheon-ro 1-gil, Dasa-eup, DaSE DECISION MADE: 31-JUL-15
Daegu  KR 711-814                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Durex Silicone
Reckitt Benckiser LLC             510(k) NO: K143532(Traditional)
ATTN: Elizabeth  Torre            PHONE NO : 973 4042715 
399 Interpace Parkway             SE DECISION MADE: 31-JUL-15
Parsippany NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: I-Portal NOTC, VNG and VOG
NEURO KINETICS, INC.              510(k) NO: K143607(Traditional)
ATTN: J. Howison  Schroeder       PHONE NO : 412 9636649 
128 GAMMA DRIVE                   SE DECISION MADE: 08-JUL-15
PITTSBURGH PA  15238              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CooperSurgical Advincula Delineator Uterine Manipulator
Cooper Surgical Inc.              510(k) NO: K143650(Traditional)
ATTN: James  Keller               PHONE NO : 1 203 6015200 
95 Corporate Drive                SE DECISION MADE: 21-JUL-15
Trumbull CT  06611                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: StarCeram® Z-Nature, StarCeram® Z-Smile
H.C. Starck Ceramics GmbH         510(k) NO: K143656(Traditional)
ATTN: Alexandra  Krausch          PHONE NO : 49 92878 070 
Lorenz-Hutschenreuther-Str. 81    SE DECISION MADE: 09-JUL-15
Selb  DE 95100                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: B40i Patient Monitor 
GE HEALTHCARE FINLAND OY          510(k) NO: K143676(Traditional)
ATTN: JOEL  KENT                  PHONE NO : 358 1039411 
KUORTANEENKATU 2                  SE DECISION MADE: 31-JUL-15
HELSINKI  FI 00510                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K143687(Traditional)
ATTN: Fatima  Pacheco             PHONE NO : 914 5242450 
511 BENEDICT AVENUE               SE DECISION MADE: 17-JUL-15
TARRYTOWN NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ASFORA ANTERIOR CERVICAL PLATE SYSTEM
MEDICAL DESIGNS, LLC              510(k) NO: K143688(Traditional)
ATTN: KRISTI  VONDRA              PHONE NO : 605 2751032 
6709 S. MINNESOTA AVE., SUITE 204 SE DECISION MADE: 01-JUL-15
SIOUX FALLS SD  57108             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Aeroneb  USB Contoller System
Aerogen Limited                   510(k) NO: K143719(Traditional)
ATTN: Martin  Crehan              PHONE NO : 353 91 540459 
Galway Business Park, Dangan      SE DECISION MADE: 10-JUL-15
Galway  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FUJIFILM Endoscope Models EC-600HL and EC-600LS
FUJIFILM Medical Systems U.S.A., I510(k) NO: K143732(Traditional)
ATTN: Mary   Moore                PHONE NO : 973 6862627 
10 High Point Drive               SE DECISION MADE: 06-JUL-15
Wayne NJ  07470                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Digital Automatic Blood Pressure Monitor MD2300
Grandway Technology (Shenzhen) Lim510(k) NO: K143735(Traditional)
ATTN: Patrick  Chow               PHONE NO : 000 852 28516789 
Block 6 and 7, Zhu Keng IndustrialSE DECISION MADE: 23-JUL-15
Shenzhen  CN 518118               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EM25 - glute toning device 
HIVOX BIOTEK, INC.                510(k) NO: K143737(Traditional)
ATTN: CLYTIE  CHIOU               PHONE NO : 886 2 85112668 
5 F., NO. 123, Shingde Road San-chSE DECISION MADE: 27-JUL-15
New Taipei City  TW 24158         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Arthrex Corkscrew and SwiveLock Suture Anchors
Arthrex, Inc.                     510(k) NO: K143745(Traditional)
ATTN: David L Rogers              PHONE NO : 239 6435553 71924
1370 Creekside Boulevard          SE DECISION MADE: 02-JUL-15
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Serenity
SANUTHERA, INC.                   510(k) NO: K150014(Traditional)
ATTN: JEFFERY  DIGIOVANNI         PHONE NO : 740 5911410 
340 WEST STATE STREET, UNIT 45    SE DECISION MADE: 27-JUL-15
ATHENS OH  45701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Z5m(t)
Z-Systems AG                      510(k) NO: K150021(Traditional)
ATTN: Thomas  Hug                 PHONE NO : 41 62 3886969 
Bittertenstrasse 15               SE DECISION MADE: 31-JUL-15
Oensingen  CH 4702                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)
Siemens Healthcare Diagnostics Inc510(k) NO: K150039(Traditional)
ATTN: Shanon  Popson              PHONE NO : 1 916 3743183 
1584 ENTERPRISE BLVD              SE DECISION MADE: 02-JUL-15
WEST SACRAMENTO CA  95691         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Exactech Alteon Monobloc Revision Stem
EXACTECH, INC.                    510(k) NO: K150066(Traditional)
ATTN: Patrick  Hughes             PHONE NO : 352 3274762 
2320 N.W. 66TH CT.                SE DECISION MADE: 20-JUL-15
GAINESVILLE FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Unimicro Veress Needle
Unimicro Medical Systems (ShenZhen510(k) NO: K150068(Traditional)
ATTN: Weizhong  Chen              PHONE NO : 0086 755 27111581 
2/F, Bldg 31, The 3rd Industrial ASE DECISION MADE: 31-JUL-15
Shenzhen  CN 518106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector
COVIDIEN                          510(k) NO: K150084(Traditional)
ATTN: SONA  MANICKAM              PHONE NO : 508 2618147 
15 HAMPSHIRE STREET               SE DECISION MADE: 13-JUL-15
MANSFIELD MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Evacore Fully Disposable Vacuum Assist Biopsy Device
Pin-Point Care Corp.              510(k) NO: K150088(Traditional)
ATTN: Jeff M Hathaway             PHONE NO : 262 6231149 
N1723 Center Street               SE DECISION MADE: 20-JUL-15
Lebanon WI  53047                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter
MICRO THERAPEUTICS INC DBA EV3 NEU510(k) NO: K150107(Traditional)
ATTN: Phuong  Chau                PHONE NO : 1 949 2975487 
9775 TOLEDO WAY                   SE DECISION MADE: 29-JUL-15
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GC Ortho Connect, GC Ortho Etching Gel
GC Orthodontics America Inc.      510(k) NO: K150128(Traditional)
ATTN: Mark  Heiss                 PHONE NO : 708 9263090 
11535 S.Central Avenue            SE DECISION MADE: 16-JUL-15
Alsip IL  60803                   510(k) STATEMENT
                                                    
 
DEVICE: OneTouch Verio Flex Blood Glucose Monitoring System
LIFESCAN EUROPE                   510(k) NO: K150214(Traditional)
ATTN: Alison  Wilson              PHONE NO : 441 463 721256 
GUBELSTRASSE 34                   SE DECISION MADE: 31-JUL-15
ZUG  CH CH-6300                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL)
THERMO FISHER SCIENTIFIC          510(k) NO: K150236(Traditional)
ATTN: CYNTHIA  KNAPP              PHONE NO : 800 8718908 322
1 THERMO FISHER WAY               SE DECISION MADE: 27-JUL-15
OAKWOOD VILLAGE OH  440146        510(k) STATEMENT
                                                    
 
DEVICE: CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX
GE HEALTHCARE FINLAND OY          510(k) NO: K150245(Traditional)
ATTN: Mari  Salmenkaita           PHONE NO : 358 10 3942122 
KUORTANEENKATU 2                  SE DECISION MADE: 17-JUL-15
HELSINKI  FI FIN-00510            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ORL Video NasoPharyngo-Larngoscope
JEDMED INSTRUMENT COMPANY         510(k) NO: K150248(Traditional)
ATTN: CRAIG  PARKS                PHONE NO : 314 8453770 
5416 JEDMED COURT                 SE DECISION MADE: 23-JUL-15
ST. LOUIS MO  63129               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Barrx Anorectal RFA Wand
Covidien LLC                      510(k) NO: K150251(Traditional)
ATTN: RACHEL  SILVA               PHONE NO : 408 3287359 
15 HAMPSHIRE STREET               SE DECISION MADE: 28-JUL-15
MANSFIELD MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Capnostream 35 Portable Respiratory Monitor
ORIDION MEDICAL 1987 LTD.         510(k) NO: K150272(Traditional)
ATTN: Dalia   Givony              PHONE NO : 972 2 5899235 
7 HAMARPE ST.                     SE DECISION MADE: 17-JUL-15
JERUSALEM  IL 9777407             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LOCATOR RTx
ZEST ANCHORS, INC.                510(k) NO: K150295(Traditional)
ATTN: Annie  Wrigth               PHONE NO : 1 760 7437744 140
2061 WINERIDGE PL.                SE DECISION MADE: 24-JUL-15
ESCONDIDO CA  92029               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Biodenta Customized Abutment-Hybrid
BIODENTA SWISS AG                 510(k) NO: K150296(Traditional)
ATTN: David  Elier                PHONE NO : 41 71747 1111 
TRAMSTRASSE 16                    SE DECISION MADE: 02-JUL-15
BERNECK  CH 9442                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NavSuite3 Kit
Stryker Leibinger GmbH & Co. KG - 510(k) NO: K150301(Special)
ATTN: Robin L Rowe                PHONE NO : 269 3893893 
Boetzinger Strasse 41             SE DECISION MADE: 08-JUL-15
Freiburg  DE D-79111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Ablation Confirmation
NEUWAVE MEDICAL INC.              510(k) NO: K150313(Traditional)
ATTN: DAN  KOSEDNAR               PHONE NO : 608 5121592 
3529 ANDERSON STREET              SE DECISION MADE: 09-JUL-15
MADISON WI  53704                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Polypectomy Snare
MICRO- TECH (NANJING) CO., LTD.   510(k) NO: K150316(Traditional)
ATTN: BECKY  LI                   PHONE NO : 86 25 58646378 
NO. 10 GAOKE THIRD ROAD           SE DECISION MADE: 30-JUL-15
NANJING  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EVOS Lumbar Interbody System
Cutting Edge Spine, LLC           510(k) NO: K150321(Traditional)
ATTN: John  Souza                 PHONE NO : 704 2430892 
101 Waxhaw Professional Park, SuitSE DECISION MADE: 13-JUL-15
Waxhaw NC  28173                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Dentis Dental Implant System
DENTIS CO., LTD.                  510(k) NO: K150344(Traditional)
ATTN: JINJU  LEE                  PHONE NO : 82 53 5822804 
99, SEONGSEOSEO-RO, DALSEO-GU     SE DECISION MADE: 24-JUL-15
DAEGU  KR 704-833                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+
DELTEX MEDICAL LIMITED            510(k) NO: K150347(Traditional)
ATTN: Paul  Dwane                 PHONE NO : 011 44 1243523160 
TERMINUS RD.                      SE DECISION MADE: 24-JUL-15
CHICHESTER  GB PO19 8TX           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Rapid Hair Removal Pads
FULL POWER AED                    510(k) NO: K150349(Traditional)
ATTN: Jahn  Power                 PHONE NO : 919 4756088 
707 East Hudson Ave               SE DECISION MADE: 14-JUL-15
Durham NC  27704                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Flexi-Seal Signal Fecal Management System
ConvaTec Ltd.                     510(k) NO: K150350(Traditional)
ATTN: Clare  Williamson           PHONE NO : 44 1244 584155 
Unit 20, First Ave, Deeside IndustSE DECISION MADE: 21-JUL-15
Deeside  GB CH5 2NU               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Cloud9 System
inSleep Technologies, LLC         510(k) NO: K150365(Traditional)
ATTN: Marty  Kerber               PHONE NO : 952 7461324 
12100 Singletree Lane Suite 183   SE DECISION MADE: 21-JUL-15
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Neodent Implant System
JJGC INDUSTRIA E COMERCIO DE MATER510(k) NO: K150367(Traditional)
ATTN: Jacson  Cambruzzi           PHONE NO : 55 41216 94058 
AV. JUSCELINO KUBITSCHEK DE OLIVEISE DECISION MADE: 13-JUL-15
CURTIBA  BR 81270-200             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Nutra Light Advanced
NUTRA LUXE MD, LLC                510(k) NO: K150370(Traditional)
ATTN: GLORIA  AVENDANO            PHONE NO : 239 5619699 
6835 INTERNATIONAL CENTER BLVD UNISE DECISION MADE: 22-JUL-15
FORT MYERS FL  33912              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH
DIROS TECHNOLOGY, INC.            510(k) NO: K150371(Traditional)
ATTN: GEORGE  DARMOS              PHONE NO : 1 905 4153440 
120 GIBSON DRIVE                  SE DECISION MADE: 30-JUL-15
MARKHAM  CA L3R 2Z3               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD               Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S
SONY ELECTRONICS, INC.            510(k) NO: K150377(Traditional)
ATTN: Amarjit Andy Singh Jowandha PHONE NO : 1 201 9306078 
1 Sony Drive, Mail Stop 3C5       SE DECISION MADE: 29-JUL-15
Park Ridge NJ  07656              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ProMIS Fixation System
Premia Spine Ltd.                 510(k) NO: K150380(Traditional)
ATTN: Ron  Sacher                 PHONE NO : 972 54 4626602 
7 Giborey Israel Street           SE DECISION MADE: 17-JUL-15
Ramat Poleg  IL 42504             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Tyber Medical Wedge System
TYBER MEDICAL LLC                 510(k) NO: K150394(Traditional)
ATTN: JEFF  TYBER                 PHONE NO : 1 303 7175060 
89 HEADQUARTERS PLAZA NORTH #1464 SE DECISION MADE: 28-JUL-15
MORRISTOWN NJ  07960              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EXPAZEN
PRODUITS DENTAIRES PIERRE ROLLAND 510(k) NO: K150423(Traditional)
ATTN: GENEVIEVE  DE VILLEDON      PHONE NO : 011 33 556340607 
17 AVENUE GUSTAVE EIFFEL ZI DU PHASE DECISION MADE: 08-JUL-15
MERIGNAC  FR 33708                510(k) STATEMENT
                                                    
 
DEVICE: 3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization
3M COMPANY                        510(k) NO: K150477(Traditional)
ATTN: MATT  MORTENSEN             PHONE NO : 651 7372670 
3M CENTER, BUILDING 275-5W-06     SE DECISION MADE: 02-JUL-15
ST. PAUL MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: JO H20 Water Based Personal Lubricant
UNITED CONSORTIUM INC.            510(k) NO: K150480(Traditional)
ATTN: Joe  Mendoza                PHONE NO : 661 2951700 
29000 HANCOCK PKWY                SE DECISION MADE: 08-JUL-15
VALENCIA CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Penguin In-Line Warmer
Creche Innovations                510(k) NO: K150484(Traditional)
ATTN: REBECCA P PINE              PHONE NO : 760 8095178 
17745 Metcalf  One Penguin Plaza  SE DECISION MADE: 09-JUL-15
Stilwell KS  66085                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Halo
J & J Solutions, Inc. d/b/a/Corvid510(k) NO: K150486(Traditional)
ATTN: Dana   Schramm              PHONE NO : 651 3983291 
2261 Crosspark Road, Suite 127    SE DECISION MADE: 24-JUL-15
Coralville IA  52241              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Cellfina System
ULTHERA, INC.                     510(k) NO: K150505(Traditional)
ATTN: Suzon  Lommel               PHONE NO : 408 6454979 
1840 S Stapley Dr Suite 200       SE DECISION MADE: 29-JUL-15
Mesa AZ  85204                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MiNi Internal Implant System
MEGAGEN IMPLANT CO., LTD          510(k) NO: K150537(Traditional)
ATTN: Dong  Guk Ha                PHONE NO : 82 53 8575770 
472, HANJANGGUN-RO, JAIN-MYEON    SE DECISION MADE: 21-JUL-15
GYEONGSAN-SI  KR 712-852          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BA400 14mm Abutment
COCHLEAR AMERICAS                 510(k) NO: K150555(Traditional)
ATTN: Tristan  Manus              PHONE NO : 800 5265798 
13059 E PEAKVIEW AVE              SE DECISION MADE: 15-JUL-15
CENTENNIAL CO  80111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Cortex Laser System
Cynosure, Inc. dba Ellman         510(k) NO: K150587(Traditional)
ATTN: Allison  Sathe              PHONE NO : 513 6588960 
400 Karin Lane                    SE DECISION MADE: 21-JUL-15
Hicksville NY  11801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon 
CONTAMAC LTD                      510(k) NO: K150590(Traditional)
ATTN: Rob  McGregor               PHONE NO : 44 179 954200 
BEARWALDEN BUSINESS PARK          SE DECISION MADE: 10-JUL-15
SAFFRON WALDEN  GB CB11 4JX       510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Zeramic Adhesive Resin Cement
Premier Dental Company Products   510(k) NO: K150601(Traditional)
ATTN: VINCENT  D'ALESSANDRO       PHONE NO : 1 610 2396000 
1710 Romano Drive                 SE DECISION MADE: 22-JUL-15
Plymouth Meeting PA  19462        510(k) STATEMENT
                                                    
 
DEVICE: MedSource ClearSafe Safety IV Catheter 
MedSource International           510(k) NO: K150611(Traditional)
ATTN: Laura  Riggen               PHONE NO : 952 2418325 
4201 Norex Drive                  SE DECISION MADE: 15-JUL-15
Chaska MN  55318                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LaserCap LC Pro and LC Elite
TRANSDERMAL CAP, INC.             510(k) NO: K150613(Traditional)
ATTN: MICHAEL  RABIN              PHONE NO : 877 7114769 
3615 SUPERIOR AVENUE, SUITE 3104F SE DECISION MADE: 22-JUL-15
CLEVELAND OH  44114               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Hypervisor IX Monitoring System
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K150632(Traditional)
ATTN: YANHONG  BAI                PHONE NO : 866 755 81885635 
MINDRAY BUILDING, KENJI 12TH ROAD SE DECISION MADE: 06-JUL-15
SHENZHEN  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MagVita TMS Therapy System
TONICA ELEKTRONIK A/S             510(k) NO: K150641(Traditional)
ATTN: Lise  Terkelsen             PHONE NO : 45 4499 8444 
LUCERNEMARKEN 15                  SE DECISION MADE: 31-JUL-15
FARUM  DK 3520                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OIC Intramedullary Nail System
ORTHOPAEDIC IMPLANT COMPANY       510(k) NO: K150655(Traditional)
ATTN: Douglas  Fulton             PHONE NO : 775 6368281 
316 CALIFORNIA AVE #701           SE DECISION MADE: 09-JUL-15
RENO NV  89509                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite
CITIEFFE s.r.l                    510(k) NO: K150661(Traditional)
ATTN: Stefano  Pullega            PHONE NO : 39 051 721850 
Via Armaroli 21                   SE DECISION MADE: 07-JUL-15
Calderara di Reno  IT 400012      510(k) STATEMENT
                                                    
 
DEVICE: STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
ETHICON, INC.                     510(k) NO: K150670(Traditional)
ATTN: DONNA  MARSHALL             PHONE NO : 908 5413990 
ROUTE 22 WEST, PO BOX 151         SE DECISION MADE: 02-JUL-15
SOMERVILLE NJ  08876              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Bard LubriGuard Foley Catheter
C.R. Bard, Inc.                   510(k) NO: K150699(Traditional)
ATTN: Michele  Davis              PHONE NO : 770 7846274 
8195 Industrial Blvd              SE DECISION MADE: 28-JUL-15
Covington GA  30014               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ACP 1 Anterior Cervical Plating System
STRYKER CORPORATION               510(k) NO: K150700(Traditional)
ATTN: Tina  Mornak                PHONE NO : 201 7608193 
2 PEARL COURT                     SE DECISION MADE: 15-JUL-15
ALLENDALE NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LTM-Perforated Surgical Mesh
LifeCell Corporation              510(k) NO: K150712(Traditional)
ATTN: Linda  Scamardella          PHONE NO : 908 9471661 
One Millennium Way                SE DECISION MADE: 02-JUL-15
Branchburg NJ  08876              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors
TORNIER, INC.                     510(k) NO: K150715(Traditional)
ATTN: Kaitlyn  Rainbow            PHONE NO : 952 4267600 
10801 NESBITT AVENUE SOUTH        SE DECISION MADE: 28-JUL-15
BLOOMINGTON MN  55437             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SculpSure
CYNOSURE, INC.                    510(k) NO: K150724(Traditional)
ATTN: KEVIN  O'CONNELL            PHONE NO : 978 3678736 
5 CARLISLE ROAD                   SE DECISION MADE: 01-JUL-15
WESTFORD MA  01886                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Muscle Stimulation System 110
NIVEUS MEDICAL, INC.              510(k) NO: K150742(Special)
ATTN: Brian  Fahey                PHONE NO : 650 3367922 
849 Independence Avenue Suite C   SE DECISION MADE: 23-JUL-15
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray
Sirona Dental Systems GMBH        510(k) NO: K150750(Traditional)
ATTN: Thomas  Diesch              PHONE NO : 49 625 116 0
Fabrikstrasse 31                  SE DECISION MADE: 02-JUL-15
Bensheim  DE 64625                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Cordelle II Sound Processor
COCHLEAR AMERICAS                 510(k) NO: K150751(Traditional)
ATTN: Laura  Blair                PHONE NO : 303 7909010 
13059 E PEAKVIEW AVENUE           SE DECISION MADE: 22-JUL-15
CENTENNIAL CO  80111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GME ExSys 308
GME (GERMAN MEDICAL ENGINEERING) G510(k) NO: K150752(Traditional)
ATTN: STEFAN  SCHULZE             PHONE NO : 49 9131 93415910 
GRIMMSTRASSE 23                   SE DECISION MADE: 31-JUL-15
NUERENBERG, BAVARIA  DE 90491     510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Micro well group culture dish, 9-well; Micro well group culture dish, 16-well
HERTART                           510(k) NO: K150756(Traditional)
ATTN: MICHAEL  TRINKLE            PHONE NO : 1 858 8240888 
Gustaf Werners gata 2             SE DECISION MADE: 20-JUL-15
V. Frolunda  SE SE-421 32         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Hyper-C Anterior Cervical Plate System
Degen Medical                     510(k) NO: K150759(Traditional)
ATTN: Craig  Black                PHONE NO : 843 9924551 
1321-C North Cashua Drive         SE DECISION MADE: 28-JUL-15
Florence SC  29501                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: E-CUBE 15 Diagnostic Ultrasound System
ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K150773(Traditional)
ATTN: DONGHWAN  KIM               PHONE NO : 82 70 74652068 
1, 6 AND 7FL, VERDI TOWER 72, DIGISE DECISION MADE: 23-JUL-15
SEOUL  KR 152-848                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Medrobotics Flex System 
MEDROBOTICS CORPORATION           510(k) NO: K150776(Traditional)
ATTN: JOHN D BONASERA             PHONE NO : 508 6926460 
475 PARAMOUNT DRIVE               SE DECISION MADE: 17-JUL-15
RAYNHAM MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Admira Fusion 
VOCO GMBH                         510(k) NO: K150784(Traditional)
ATTN: M TH PLAUMANN               PHONE NO : 49 4721 7190 
ANTON-FLETTNER-STR. 1-3           SE DECISION MADE: 02-JUL-15
CUXHAVEN  DE 27472                510(k) STATEMENT
                                                    
 
DEVICE: Atrax Anterior Cervical Plating System
X-Spine Systems, Inc              510(k) NO: K150834(Traditional)
ATTN: David   Kirschman           PHONE NO : 937 8478400 
452 Alexandersville Rd.           SE DECISION MADE: 10-JUL-15
Miamisburg OH  45342              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K150839(Traditional)
ATTN: PETER J. CORONADO           PHONE NO : 1 650 4246320 
911 HANSEN WAY                    SE DECISION MADE: 17-JUL-15
PALO ALTO CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff
COVIDIEN                          510(k) NO: K150844(Traditional)
ATTN: Danielle   Mueller          PHONE NO : 303 3052603 
6135 GUNBARREL AVE                SE DECISION MADE: 14-JUL-15
BOULDER CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Refobacin Bone Cement R
BIOMET, INC.                      510(k) NO: K150850(Traditional)
ATTN: CARMEN  ALBANY              PHONE NO : 574 3713024 
56 EAST BELL DRIVE                SE DECISION MADE: 16-JUL-15
WARSAW IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Reform Pedicle Screw System
PRECISION SPINE, INC.             510(k) NO: K150856(Special)
ATTN: Michael  Dawson             PHONE NO : 601 4204424 
2050 EXECUTIVE DRIVE              SE DECISION MADE: 07-JUL-15
PEARL MS  39208                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: QBit Series Diagnostic Ultrasound System
CHISON MEDICAL IMAGING CO., LTD.  510(k) NO: K150861(Traditional)
ATTN: QIFEI  LIU                  PHONE NO : 0086 510 85311707 
NO.228, CHANGJIANG EAST ROAD,BLOCKSE DECISION MADE: 28-JUL-15
WUXI  CN 214142                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SURGISEAL Topical Skin Adhesvie
ADHEZION BIOMEDICAL, LLC          510(k) NO: K150866(Special)
ATTN: TRACY  LOFGREN              PHONE NO : 970 3794707 
ONE MERIDIAN BOULEVARD, SUITE 1B02SE DECISION MADE: 17-JUL-15
WYOMISSING PA  19610              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BruxZir Anterior Milling Blanks 
PRISMATIK DENTALCRAFT, INC.       510(k) NO: K150872(Traditional)
ATTN: ARMIN  ZEHTABCHI            PHONE NO : 949 2251269 
2212 DUPONT DRIVE SUITE P         SE DECISION MADE: 02-JUL-15
IRVINE CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System
ACCURAY INCORPORATED              510(k) NO: K150873(Traditional)
ATTN: Shweta  Kaushik             PHONE NO : 408 7164600 
1310 CHESAPEAKE TERRACE           SE DECISION MADE: 01-JUL-15
SUNNYVALE CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
NOVO NORDISK INC.                 510(k) NO: K150874(Special)
ATTN: Poonam  Tuliani             PHONE NO : 609 7865210 
P.O. BOX 846                      SE DECISION MADE: 31-JUL-15
PLAINSBORO NJ  08536              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: iFuse Implant System
SI-BONE, Inc.                     510(k) NO: K150875(Traditional)
ATTN: Roxanne  Dubois             PHONE NO : 408 2070700 2236
3055 Olin Avenue, Suite 2200      SE DECISION MADE: 22-JUL-15
San Jose CA  95128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ILUMIEN OPTIS 
LIGHTLAB IMAGING,INC.             510(k) NO: K150878(Traditional)
ATTN: ERDIE  DE PERALTA           PHONE NO : 978 5773481 
4 ROBBINS ROAD                    SE DECISION MADE: 15-JUL-15
WESTFORD MA  01886                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Trojan Riviera Personal Lubricant
CHURCH & DWIGHT CO., INC.         510(k) NO: K150886(Traditional)
ATTN: LISA  BURNS                 PHONE NO : 1 609 8061997 
500 CHARLES EWING BLVD.           SE DECISION MADE: 20-JUL-15
EWING NJ  08628                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Suture Wires and Wire Loops
ZIMMER, INC.                      510(k) NO: K150889(Traditional)
ATTN: PATRICK  MCCULLAGH          PHONE NO : 1 574 3724656 
P.O. BOX 708                      SE DECISION MADE: 01-JUL-15
WARSAW IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
EDAN INSTRUMENTS, INC.            510(k) NO: K150901(Traditional)
ATTN: Queena  Chen                PHONE NO : 86 75526 858736 
3/F - B, NANSHAN MEDICAL EQUIPMENTSE DECISION MADE: 01-JUL-15
SHENZHEN  CN 518067               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type
MAANSHAN BOND MEDICAL INSTRUMENTS 510(k) NO: K150903(Traditional)
ATTN: Viva  Gu                    PHONE NO : 86 555 2108175 
1358 Meishan Road, Economic & TechSE DECISION MADE: 15-JUL-15
Maanshan  CN 243041               510(k) STATEMENT
                                                    
 
DEVICE: ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh
EHICON INC.                       510(k) NO: K150906(Traditional)
ATTN: SUSAN  LIN                  PHONE NO : 908 2182256 
ROUTE22 WEST, P.O. BOX 151        SE DECISION MADE: 24-JUL-15
SOMERVILLE  NJ  08876-0151        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
Ellipse A/S                       510(k) NO: K150907(Traditional)
ATTN: Ole  Kofod                  PHONE NO : 45 4517 6863 
Agern Alle 11                     SE DECISION MADE: 07-JUL-15
Hoersholm  DK DK-2970             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: INTEGO Family and Accesories
Sirona Dental Systems GMBH        510(k) NO: K150909(Traditional)
ATTN: Thomas  Diesch              PHONE NO : 49 6251 160 
Fabrikstrasse 31                  SE DECISION MADE: 17-JUL-15
Bensheim  DE 64625                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Houva-NET Control System
National Biological Corporation   510(k) NO: K150912(Traditional)
ATTN: Lynn  Keller                PHONE NO : 216 8310600 227
23700 Mercantile Road             SE DECISION MADE: 10-JUL-15
Beachwood OH  44122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ArgenZ Esthetic Plus
THE ARGEN CORPORATION             510(k) NO: K150919(Abbreviated)
ATTN: CRAIG  JOLICOEUR            PHONE NO : 1 858 4557900 471
5855 OBERLIN DRIVE                SE DECISION MADE: 13-JUL-15
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device
ANCHOR INNOVATION MEDICAL (A.I.M.)510(k) NO: K150924(Traditional)
ATTN: CARY  STALNECKER            PHONE NO : 301 7707871 
5410 EDSON LANE, SUITE 308        SE DECISION MADE: 27-JUL-15
ROCKVILLE MD  20852               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: iBond Universal & iBond Ceramic Primer
Heraeus Kulzer LLC, Mitsui Chemica510(k) NO: K150933(Traditional)
ATTN: Jamie  Cleveland            PHONE NO : 574 2995421 
3001 Heraeus Way                  SE DECISION MADE: 07-JUL-15
South Bend IN  46614              510(k) STATEMENT
                                                    
 
DEVICE: SpeediCath Compact Eve
COLOPLAST A/S                     510(k) NO: K150935(Traditional)
ATTN: Meg  Daniel                 PHONE NO : 612 3024930 
1601 WEST RIVER ROAD NORTH        SE DECISION MADE: 02-JUL-15
MINNEAPOLIS MN  55411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Straumann® Dental Implant System ¿ Roxolid® SLA Implants
STRAUMANN USA, LLC                510(k) NO: K150938(Traditional)
ATTN: CHRISTOPHER  KLACZYK        PHONE NO : 978 7472575 
60 MINUTEMAN ROAD                 SE DECISION MADE: 24-JUL-15
ANDOVER MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC
BIO COMPRESSION SYSTEMS, INC.     510(k) NO: K150953(Special)
ATTN: Barbara J Whitman           PHONE NO : 800 8880908 
120 W COMMERCIAL AVE.             SE DECISION MADE: 16-JUL-15
MOONACHIE NJ  07074               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: TRU Dental Implant System 
Sterngold Dental, LLC             510(k) NO: K150968(Abbreviated)
ATTN: Maria  Rao                  PHONE NO : 508 2265660 
23 Frank Mossberg Drive           SE DECISION MADE: 24-JUL-15
Attleboro MA  02703               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Pyrenees Cervical Plate System
K2M                               510(k) NO: K150983(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
751 Miller Drive SE               SE DECISION MADE: 14-JUL-15
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ECVUE Mapping System
CardioInsight Technologies, Inc.  510(k) NO: K150990(Special)
ATTN: Christina V Vacca           PHONE NO : 216 4535950 105
11000 Cedar Ave. Suite 210        SE DECISION MADE: 02-JUL-15
Cleveland OH  44106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Electronic Pulse Stimulator
SHENZHEN JINGKEHUI ELECTRONIC CO.,510(k) NO: K150995(Traditional)
ATTN: PU  JIANG                   PHONE NO : 86 755 27926589 
5F, BUILDING 12, HENGMINGZHU INDUSSE DECISION MADE: 06-JUL-15
SHENZHEN  CN 518104               510(k) STATEMENT
                                                    
 
DEVICE: Piccolo Composite Nailing System 
CARBOFIX ORTHOPEDICS LTD.         510(k) NO: K151010(Traditional)
ATTN: YAEL  RUBIN                 PHONE NO : 972 9 9511511 
11 HA'HOSHLIM STREET              SE DECISION MADE: 28-JUL-15
HERZELIYA  IL 46724               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Aura DR 43C-AG flat panel detector
ABYZR CO., LTD                    510(k) NO: K151014(Traditional)
ATTN: JOHN  LIM                   PHONE NO : 82 70 86804100 
#63-27, GEUMGOK-RO, DONGTAN-MYEON SE DECISION MADE: 13-JUL-15
HWASEONG-SI  KR 445-811           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ECHELON Oval V 5.0 MRI System
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K151015(Traditional)
ATTN: DOUG  THISTLETHWAITE        PHONE NO : 1 330 4251313 
1959 SUMMIT COMMERCE PARK         SE DECISION MADE: 29-JUL-15
TWINSBURG OH  44087               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Rampart-T Interbody Fusion System
Spineology, Inc.                  510(k) NO: K151020(Special)
ATTN: Tim  Crabtree               PHONE NO : 651 2568534 
7800 3rd Street N.                SE DECISION MADE: 22-JUL-15
Saint Paul MN  55128              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OsteoMed Cannulated Screw System
OSTEOMED CORP.                    510(k) NO: K151021(Special)
ATTN: Blesson  Abraham            PHONE NO : 1 972 6774795 
3885 Arapho Road                  SE DECISION MADE: 15-JUL-15
Addison TX  75001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Philips Self-Adhesive Electrodes
PHILIPS CONSUMER LIFESTYLE        510(k) NO: K151033(Traditional)
ATTN: MARTA   WALKER              PHONE NO : 31 6 31978546 
1600 SUMMER STREET                SE DECISION MADE: 28-JUL-15
STAMFORD CT  06905                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PulseRelief
PHILIPS CONSUMER LIFESTYLE        510(k) NO: K151035(Traditional)
ATTN: Marta  Walker               PHONE NO : 31 6 31978546 
1600 SUMMER STREET                SE DECISION MADE: 21-JUL-15
STAMFORD CT  06905                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle
CONMED CORPORATION                510(k) NO: K151037(Special)
ATTN: NYROBIA  FREEMAN            PHONE NO : 727 3995416 
525 FRENCH ROAD                   SE DECISION MADE: 09-JUL-15
UTICA NY  11502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EPX-Series Mobile X-ray System
ECOTRON CO.,LTD                   510(k) NO: K151038(Traditional)
ATTN: SANG BONG LEE               PHONE NO : 82 2 20253760 
RM 504, HANSHIN IT TOWER II, 47, DSE DECISION MADE: 24-JUL-15
SEOUL  KR 153-712                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: TENEO Dental Treatment Unit and Accessories
SIRONA DENTAL SYSTEMS GMBH        510(k) NO: K151045(Traditional)
ATTN: THOMAS  DIESCH              PHONE NO : 49 6251 160 
FABRIKSTRASSE 31                  SE DECISION MADE: 24-JUL-15
BENSHEIM  DE 64625                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10
MERIDIAN BIOSCIENCE, INC.         510(k) NO: K151046(Traditional)
ATTN: STEFANIE  JOHNS             PHONE NO : 513 2713700 
3471 River Hills Dr               SE DECISION MADE: 17-JUL-15
CINCINNATI OH  45244              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner
SOPRO - ACTEON GROUP              510(k) NO: K151053(Traditional)
ATTN: PHILIPPE  BOYER             PHONE NO : 011 33 442980101 
ZAC ATHELIA IV AVENUE DES GENEVRIESE DECISION MADE: 31-JUL-15
LA CIOTAT  FR 13705               510(k) STATEMENT
                                                    
 
DEVICE: Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System
C2 Therapeutics, Inc.             510(k) NO: K151054(Special)
ATTN: Theresa   Brandner-Allen    PHONE NO : 650 5215921 
303 Convention Way, Suite 1       SE DECISION MADE: 07-JUL-15
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Ventilation (Tympanostomy) Tubes
Medtronic Xomed, Inc.             510(k) NO: K151067(Traditional)
ATTN: Michelle  Hughes            PHONE NO : 904 3322489 
6743 Southpoint Drive North       SE DECISION MADE: 22-JUL-15
Jacksonville FL  32216            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SureLock W Suture Anchor
CAYENNE MEDICAL, INC              510(k) NO: K151068(Traditional)
ATTN: SHIMA  HASHEMIAN            PHONE NO : 480 5023661 249
16597 N 92ND STREET               SE DECISION MADE: 24-JUL-15
SCOTTSDALE AZ  85260              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Vitrea Software Toshiba Package, VSTP-001A
Toshiba Medical Systems Corporatio510(k) NO: K151091(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 13-JUL-15
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Mosaic Universal Composite 
ULTRADENT PRODUCTS, INC.          510(k) NO: K151094(Traditional)
ATTN: KAREN  KAKUNES              PHONE NO : 801 5534366 
505 W 10200 S                     SE DECISION MADE: 21-JUL-15
SOUTH JORDAN UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Lotus Series 4 Ultrasonic Surgical System & Accessories
SRA DEVELOPMENTS, LTD.            510(k) NO: K151101(Special)
ATTN: Alan  Chivers               PHONE NO : 44 01364 652426 
BREMRIDGE HOUSE                   SE DECISION MADE: 17-JUL-15
ASHBURTON, DEVON  GB TQ13 7JX     510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor
Smith & Nephew, Inc.              510(k) NO: K151105(Traditional)
ATTN: Katherine  Marcaccio        PHONE NO : 508 2613602 
130 Forbes Boulevard              SE DECISION MADE: 28-JUL-15
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CoSense ETCO Monitor
Capnia Inc                        510(k) NO: K151107(Special)
ATTN: KRISTEN  YEN                PHONE NO : 650 3532051 
3 TWIN DOLPHIN DRIVE SUITE 160    SE DECISION MADE: 22-JUL-15
REDWOOD CITY CA  04065            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ELITech Clinical Systems CALCIUM ARSENAZO
ELITechGroup                      510(k) NO: K151113(Traditional)
ATTN: Valerie  Gourdon            PHONE NO : 330 23381 2100 
ZONE INDUSTRIELLE                 SE DECISION MADE: 22-JUL-15
Sees  FR 61500                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Smith and Nephew Legion Hinge Knee System
SMITH & NEPHEW                    510(k) NO: K151118(Traditional)
ATTN: ALLISON  CHAN               PHONE NO : 1 901 3996670 
7135 GOODLETT FARMS PARKWAY       SE DECISION MADE: 28-JUL-15
CORDOVA TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EndoLIF On-Cage
JOIMAX GMBH                       510(k) NO: K151143(Traditional)
ATTN: Eulodie  Tila               PHONE NO : 49 07212 55140 
AMALIENBADSTRASSE 41 Raumfabrik 61SE DECISION MADE: 09-JUL-15
KARLSRUHE  DE 76227               510(k) STATEMENT
                                                    
 
DEVICE: N-Force Fixation System
INNOVISION, INC.                  510(k) NO: K151146(Traditional)
ATTN: KEITH  RUSSELL              PHONE NO : 1 901 3705700 
1975 NONCONNAH BLVD.              SE DECISION MADE: 24-JUL-15
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: STARband, STARlight
ORTHOMERICA PRODUCTS, INC.        510(k) NO: K151147(Traditional)
ATTN: DAVID C. KERR               PHONE NO : 407 2906592 
6333 NORTH ORANGE BLOSSOM TRAIL   SE DECISION MADE: 01-JUL-15
ORLANDO FL  32810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Elements
PAC-DENT INTERNATIONAL, INC.      510(k) NO: K151150(Traditional)
ATTN: WENYING   ZHU               PHONE NO : 909 8390888 
670 ENDEAVOR CIRCLE               SE DECISION MADE: 28-JUL-15
BREA CA  92821                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Tosama 100% Organic Cotton Menstrual Tampon
TOSAMA D.O.O.                     510(k) NO: K151170(Third Party - Traditional)
ATTN: MARJETKA KRALJ KUNCIC       PHONE NO : 00386 1 7290370 
SARANOVICEVA CESTA 35 VIR         SE DECISION MADE: 02-JUL-15
VIR, DOMZALE  SI 1230             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: XenMatrix AB Surgical Graft
C.R. Bard                         510(k) NO: K151177(Traditional)
ATTN: Tony  John                  PHONE NO : 401 8258692 
100 Crossings Boulevard           SE DECISION MADE: 30-JUL-15
Warwick RI  02886                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: InFill Interbody Fusion Devices
PINNACLE SPINE GROUP, LLC         510(k) NO: K151184(Traditional)
ATTN: REBECCA K PINE              PHONE NO : 760 8095178 
1601 ELM STREET, SUITE 300        SE DECISION MADE: 14-JUL-15
DALLAS TX  75201                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: QuadraSphere Microspheres
BIOSPHERE MEDICAL S.A.            510(k) NO: K151187(Traditional)
ATTN: ALIX  FONLLADOSA            PHONE NO : 33 148 172529 
PARC DES NATIONS - PARIS NORD 2, 3SE DECISION MADE: 27-JUL-15
ROISSY-EN-FRANCE  FR 95700        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Nautilus Spinal System
LIFE SPINE, INC                   510(k) NO: K151196(Traditional)
ATTN: RANDY  LEWIS                PHONE NO : 847 8846117 
13951 S. Quality Drive            SE DECISION MADE: 14-JUL-15
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Lariat snare
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K151197(Traditional)
ATTN: SAGAR  PIMPALWAR            PHONE NO : 440 3586263 
5976 HEISLEY ROAD                 SE DECISION MADE: 06-JUL-15
MENTOR OH  44060                  510(k) STATEMENT
                                                    
 
DEVICE: A-CIFT SoloFuse
SPINEFRONTIER, INC.               510(k) NO: K151198(Special)
ATTN: MANTHAN J DAMANI            PHONE NO : 978 2323990 252
500 CUMMINGS CENTER, STE 3500     SE DECISION MADE: 17-JUL-15
BEVERLY MA  01915                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SmartDrive Wheelchair Power Assist
MAX MOBILITY, LLC                 510(k) NO: K151199(Third Party - Traditional)
ATTN: Ben  Hemkens                PHONE NO : 800 6372980 
5425 Crossings Blvd.              SE DECISION MADE: 30-JUL-15
Antioch TN  37013                 510(k) STATEMENT
                                  THIRD PARTY REVIEW
 
DEVICE: HEMO-Bandage
CORELEADER BIOTECH CO., LTD.      510(k) NO: K151204(Traditional)
ATTN: Ya-Wen  Kuo                 PHONE NO : 886 2269 68880 
19F BUILD B, NO. 100, SEC 1 XINTAISE DECISION MADE: 31-JUL-15
NEW TAIPEI CITY  TW 22102         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Proton Immobilization Solution
ORFIT INDUSTRIES NV               510(k) NO: K151207(Traditional)
ATTN: EDDY  MARIVOET              PHONE NO : 32 03 3262026 
VOSVELD 9A                        SE DECISION MADE: 28-JUL-15
WIJNEGEM  BE B-2110               510(k) STATEMENT
                                                    
 
DEVICE: Monaco
IMPAC MEDICAL SYSTEMS, INC.       510(k) NO: K151233(Traditional)
ATTN: KATHRYN  STINSON            PHONE NO : 314 9930003 
13723 Riverport Drive Suite 100   SE DECISION MADE: 07-JUL-15
Maryland Heights MO  63043        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CARDIOSAVE Hybrid Intra-Aortic Balloon Pump
DATASCOPE CORP.                   510(k) NO: K151254(Special)
ATTN: Helder A Sousa              PHONE NO : 973 7097465 
1300 MACARTHUR BLVD               SE DECISION MADE: 02-JUL-15
MAHWAH NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Gemini XXP-HP
Dornier MedTech America           510(k) NO: K151298(Traditional)
ATTN: John  Hoffer                PHONE NO : 770 5146163 
1155 Roberts Blvd                 SE DECISION MADE: 30-JUL-15
Kennesaw GA  30144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CinchLock Flex Knotless Suture Anchor
Pivot Medical                     510(k) NO: K151314(Special)
ATTN: Kelly  Kucharczyk           PHONE NO : 810 8134672 
247 Humboldt Court                SE DECISION MADE: 23-JUL-15
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Armada 18 PTA Catheter
ABBOTT VASCULAR                   510(k) NO: K151317(Special)
ATTN: Shu Chi Hsu                 PHONE NO : 408 8451256 
3200 LAKESIDE DR                  SE DECISION MADE: 06-JUL-15
SANTA CLARA CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device
Smith & Nephew, Inc.              510(k) NO: K151326(Special)
ATTN: Laura  Reynolds             PHONE NO : 727 3997702 
970 Lake Carillon Drive, Suite 110SE DECISION MADE: 16-JUL-15
St. Petersburg FL  33716          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Microlife Wrist Watch Blood Pressure Monitor
MICROLIFE INTELLECTUAL PROPERTY Gm510(k) NO: K151330(Traditional)
ATTN: GERHARD   FRICK             PHONE NO : 41 71 7277000 
ESPENSTRASSE 139, 9443            SE DECISION MADE: 14-JUL-15
WIDNAU  CH 9443                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: HARMONIC Focus Long Shears + Adaptive Tissue Technology
ETHICON ENDO-SURGERY, LLC         510(k) NO: K151340(Special)
ATTN: MARJORIE  MEDINA            PHONE NO : 787 7186654 
475 CALLE C                       SE DECISION MADE: 10-JUL-15
GUAYNABO PR  00969                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Zephyr Vascular Compression Device
ADVANCED VASCULAR DYNAMICS        510(k) NO: K151363(Traditional)
ATTN: MATTHEW  SEMLER             PHONE NO : 503 2232333 
4252 SE INTERNATIONAL WAY, STE. F SE DECISION MADE: 31-JUL-15
MILWAUKIE OR  97222               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare
MEDICAL COMPRESSION SYSTEM (DBN) L510(k) NO: K151377(Traditional)
ATTN: EYAL  SANDACH               PHONE NO : 972 4 6266630 
12 HA'LLAN STREET, PO BOX 75      SE DECISION MADE: 16-JUL-15
OR-AKIVA  IL 306000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
Immunalysis Corporation           510(k) NO: K151395(Traditional)
ATTN: Joseph  Ginete              PHONE NO : 909 4820840 
829 Towne Center Drive            SE DECISION MADE: 24-JUL-15
Pomona CA  91767                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Monster Screw System
PARAGON 28                        510(k) NO: K151418(Special)
ATTN: FRANK S. BONO               PHONE NO : 888 7281888 
4B INVERNESS CT. E., STE 280      SE DECISION MADE: 15-JUL-15
ENGLEWOOD CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Dentrix Ascend Imaging
REALCLOUD IMAGING INC.            510(k) NO: K151438(Third Party - Traditional)
ATTN: DOUGLAS A. GOLAY            PHONE NO : 712 3013882 
2060 ALAMEDA PADRE SERRA, SUITE 10SE DECISION MADE: 07-JUL-15
SANTA BARBARA CA  93013           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: Axium Detachable Coil System
MICRO THERAPEUTICS, INC. D/B/A EV3510(k) NO: K151447(Special)
ATTN: PATRICIA  CASING            PHONE NO : 949 6801307 
9775 TOLEDO WAY                   SE DECISION MADE: 28-JUL-15
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Aplio 500/400/300 Diagnostic Ultrasound System V6.0
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K151451(Traditional)
ATTN: PAUL  BIGGINS               PHONE NO : 1 714 6697808 
1385 SHIMOISHIGAMI                SE DECISION MADE: 09-JUL-15
OTAWARA-SHI  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
ALERE SCARBOROUGH, INC.           510(k) NO: K151464(Traditional)
ATTN: ANGELA  DRYSDALE            PHONE NO : 207 7305737 
10 SOUTHGATE ROAD                 SE DECISION MADE: 28-JUL-15
SCARBOROUGH ME  04074             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Wondfo CR3 Keyless Split Sample Cup
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K151478(Special)
ATTN: BEN  CHEN                   PHONE NO : 86 20 32296069 
WONDFO SCIENTECH PARK, SOUTH CHINASE DECISION MADE: 01-JUL-15
GUANGZHOU  CN 510641              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Biomet Spine Fusion System
Biomet Spine LLC.                 510(k) NO: K151483(Traditional)
ATTN: Ted  Kuhn                   PHONE NO : 303 5018549 
310 Interlocken Parkway, Suite 120SE DECISION MADE: 31-JUL-15
Broomfield CO  80021              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Biograph mCT and mCT Flow PET/CT Scanners
Siemens Medical Solutions USA, Inc510(k) NO: K151486(Special)
ATTN: ALAINE  MEDIO               PHONE NO : 1 865 2182703 
810 INNOVATION DRIVE              SE DECISION MADE: 17-JUL-15
KNOXVILLE TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
Orthofix, Inc.                    510(k) NO: K151488(Special)
ATTN: Jacki  Geren                PHONE NO : 214 9372100 
3451 Plano Parkway                SE DECISION MADE: 07-JUL-15
Lewisville TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EN Snare Endovascular Snare System
MERIT MEDICAL SYSTEMS INC         510(k) NO: K151497(Special)
ATTN: MARK  MULLANEY              PHONE NO : 353 91 703700 3061
PARKMORE BUSINESS PARK WEST       SE DECISION MADE: 01-JUL-15
GALWAY  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Coronis Uniti
Barco N.V.                        510(k) NO: K151505(Traditional)
ATTN: Franky  Dubois              PHONE NO : 32 5623 3531 
President Kennedypark 35          SE DECISION MADE: 17-JUL-15
Kortrijk  BE 8500                 510(k) STATEMENT
                                                    
 
DEVICE: Arrow Endurance Extended Dwell Peripheral Catheter System 
Arrow Internation, Inc. (subsidiar510(k) NO: K151513(Third Party - Traditional)
ATTN: Tracy  Larish               PHONE NO : 610 3780131 
2400 Bernville Rd                 SE DECISION MADE: 08-JUL-15
Reading PA  19605                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: Uncoated Tubing and Connector Components
MEDTRONIC, INC.                   510(k) NO: K151523(Special)
ATTN: JACQUELINE A. HAUGE         PHONE NO : 1 763 5149967 
7611 Northland Drive              SE DECISION MADE: 16-JUL-15
Brooklyn Park MN  55428           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CardioChek Plus Test System
POLYMER TECHNOLOGY SYSTEMS, INC.  510(k) NO: K151530(Traditional)
ATTN: Megan  Burns                PHONE NO : 317 8705610 
7736 Zionsville Rd                SE DECISION MADE: 07-JUL-15
INDIANAPOLIS IN  46268            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: KYPHON ELEMENT Inflatable Bone Tamp
MEDTRONIC, INC.                   510(k) NO: K151532(Traditional)
ATTN: PAMELA  EDWARDS             PHONE NO : 1 901 3963133 
1800 PYRAMID PLACE                SE DECISION MADE: 23-JUL-15
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: HemosIL D-Dimer HS
INSTRUMENTATION LABORATORY CO.    510(k) NO: K151534(Special)
ATTN: NIKITA  MALLADI             PHONE NO : 1 781 6743245 
180 HARTWELL Road                 SE DECISION MADE: 06-JUL-15
BEDFORD MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm
MRI INTERVENTIONS, INC.           510(k) NO: K151536(Special)
ATTN: E F WADDELL                 PHONE NO : 949 9006833 
5 MUSICK                          SE DECISION MADE: 08-JUL-15
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Graft Delivery Device with Integrated Stylet
Micromedics Inc. (d/b/a Nordson Me510(k) NO: K151543(Special)
ATTN: Amy L Peterson              PHONE NO : 651 4521977 
1270 Eagan Industrial Rd, Suite 12SE DECISION MADE: 07-JUL-15
St.Paul MN  55121                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VersaOne Bladed Trocar, VersaOne Bladeless Trocar
COVIDIEN                          510(k) NO: K151548(Special)
ATTN: Trang  Huynh                PHONE NO : 203 4927473 
60 Middletown Avenue              SE DECISION MADE: 02-JUL-15
North Haven CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
ELITechGroup                      510(k) NO: K151552(Abbreviated)
ATTN: Valerie  Gourdon            PHONE NO : 330 23381 2100 
ZONE INDUSTRIELLE                 SE DECISION MADE: 08-JUL-15
Sees  FR 61500                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine
NANTONG EGENS BIOTECH CO., LTD.   510(k) NO: K151557(Traditional)
ATTN: BEN  CHEN                   PHONE NO : 86 513 85327458 
BUILDING 15, 1692 XINGHU AVENUE   SE DECISION MADE: 16-JUL-15
NANTONG  CN 226010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Abbott ARCHITECT Total T4 Calibrators
ABBOTT LABORATORIES               510(k) NO: K151566(Traditional)
ATTN: Lisa  Lukowski              PHONE NO : 224 6688849 
100 Abbott Park Road Dept. 09VA, ASE DECISION MADE: 10-JUL-15
Abbott Park IL  60064             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Arthrex OrthoVis Preoperative Plan
Custom Orthopaedic Solutions, Inc.510(k) NO: K151568(Traditional)
ATTN: Peter  O'Neill              PHONE NO : 216 4066149 
10000 Cedar Ave.                  SE DECISION MADE: 31-JUL-15
Cleveland OH  44106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Penumbra Smart Coil
PENUMBRA, INC.                    510(k) NO: K151572(Special)
ATTN: CHARLES  DENAULT            PHONE NO : 510 7483302 
ONE PENUMBRA PLACE                SE DECISION MADE: 10-JUL-15
ALAMEDA CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Leva Spacer System
SPINE WAVE, INC.                  510(k) NO: K151581(Special)
ATTN: GAIL  YAEKER-DAUNIS         PHONE NO : 1 203 9449494 
3 ENTERPRISE DRIVE, SUITE 210     SE DECISION MADE: 09-JUL-15
SHELTON CT  06484                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AT235
INTERACOUSTICS A/S                510(k) NO: K151616(Special)
ATTN: ERIK  NIELSEN               PHONE NO : 45 637 13555 
DREJERVAENGET 8                   SE DECISION MADE: 15-JUL-15
ASSENS  DK DK-5610                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter
St. Jude Medical                  510(k) NO: K151622(Special)
ATTN: Maria  Obreztchikova        PHONE NO : 651 7564424 
14901 DeVeau Place                SE DECISION MADE: 15-JUL-15
Minnetonka MN  55345              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Medline ENFit Connectors
MEDLINE INDUSTRIES, INC.          510(k) NO: K151628(Traditional)
ATTN: STEPHANIE  BLAIR            PHONE NO : 847 6433690 
ONE MEDLINE PLACE                 SE DECISION MADE: 24-JUL-15
MUNDELEIN IL  60060               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PROW FUSION
NLT SPINE LTD                     510(k) NO: K151654(Special)
ATTN: Eti  Zinger                 PHONE NO : 972 6344514 
6 YAD HARUTZIM ST.                SE DECISION MADE: 17-JUL-15
KFAR-SABA  IL 44641               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks 
Covidien LLC                      510(k) NO: K151659(Special)
ATTN: Mary   Mellows              PHONE NO : 203 4925284 
60 Middletown Avenue              SE DECISION MADE: 17-JUL-15
North Haven CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MultiFIX S Knotless Fixation System
ArthroCare Corporation            510(k) NO: K151660(Special)
ATTN: Laura  Kasperowicz          PHONE NO : 949 5852406 
15285 Alton Parkway, Suite 200    SE DECISION MADE: 16-JUL-15
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Retracta Detachable Embolization Coil
COOK INCORPORATED                 510(k) NO: K151676(Special)
ATTN: DAVID   LEHR                PHONE NO : 812 3353575 102309
750 DANIELS WAY                   SE DECISION MADE: 22-JUL-15
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LnK Cervical Interbody Fusion Cage System
L&K BIOMED Co.,Ltd.               510(k) NO: K151677(Special)
ATTN: Yerim  An                   PHONE NO : 82 2 67171985 
#201, 202 16-25, Dongbaekjungang-rSE DECISION MADE: 15-JUL-15
Giheung-gu,Yongin-si  KR 446-916  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: IntelliVue Patient Monitor
PHILIPS MEDIZIN SYSTEME BOEBLINGEN510(k) NO: K151681(Special)
ATTN: JOHANNES   SCHMID           PHONE NO : 49 7031 4631315 
HEWLETT-PACKARD STR. 2            SE DECISION MADE: 17-JUL-15
BOEBLINGEN  DE 71034              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GUA60A, GU60A-65
SAMSUNG ELECTRONICS CO., LTD.     510(k) NO: K151685(Traditional)
ATTN: Chulsin  Kim                PHONE NO : 82 31 2007661 
129, SAMSUNG-RO YEONGTONG-GU      SE DECISION MADE: 17-JUL-15
SUWON-SI  KR 443-742              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Alere i Instrument, Alere i Influenza A & B, Alere i Strep A
ALERE SCARBOROUGH, INC.           510(k) NO: K151690(Special)
ATTN: Angela  Drysdale            PHONE NO : 207 7305737 
10 Southgate Road                 SE DECISION MADE: 16-JUL-15
Scarborough ME  04074             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Caiman Seal and Cut Technology
AESCULAP, INC.                    510(k) NO: K151696(Special)
ATTN: Denise  Adams               PHONE NO : 610 9849076 
3773 CORPORATE  PARKWAY           SE DECISION MADE: 20-JUL-15
CENTER VALLEY PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BD Angiocath IV Catheter, BD Insyte IV Catheter
BECTON DICKINSON INFUSION THERAPY 510(k) NO: K151698(Third Party - Traditional)
ATTN: HENRY  BOLAND               PHONE NO : 801 5652550 
9450 SOUTH STATE STREET           SE DECISION MADE: 27-JUL-15
SANDY UT  84070                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i
RAYENCE CO., LTD                  510(k) NO: K151707(Special)
ATTN: KEVIN  KIM                  PHONE NO : 82 31 80156459 
14, SAMSUNG 1-RO, 1-GIL           SE DECISION MADE: 19-JUL-15
HWASEONG-SI  KR 445-170           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Hi-Light Diagnostic Ultrasound Systems
Qingdao Hisense Medical Equipment 510(k) NO: K151709(Third Party - Traditional)
ATTN: Wang  Wei                   PHONE NO : 860 532 80876010 
No. 169 Songling Road, Laoshan DisSE DECISION MADE: 17-JUL-15
Qingdao  CN 266071                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: Magellan Robotic System
HANSEN MEDICAL, INC.              510(k) NO: K151730(Special)
ATTN: TODD  MILHOLLAND            PHONE NO : 650 4042777 
800 EAST MIDDLEFIELD ROAD         SE DECISION MADE: 23-JUL-15
MOUNTAIN VIEW CA  94034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OASYS(r) System
Stryker Corporation               510(k) NO: K151755(Traditional)
ATTN: Garry T Hayeck              PHONE NO : 201 7608043 
2 Pearl Court                     SE DECISION MADE: 09-JUL-15
Allendale NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Barricade Embolization Coil System
BLOCKADE MEDICAL                  510(k) NO: K151760(Special)
ATTN: REBECCA K. PINE             PHONE NO : 1 760 8095178 
18 Technology Dr Ste 169          SE DECISION MADE: 27-JUL-15
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: 3D/5D Viewer
SAMSUNG MEDISON CO., LTD          510(k) NO: K151808(Third Party - Traditional)
ATTN: KIM  JIYOUNG                PHONE NO : 82 2 21941299 
42, TEHERAN-RO 108-GIL,           SE DECISION MADE: 29-JUL-15
GANGNAM-GU  KR                    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: Sniper Spine System
SPINE WAVE, INC.                  510(k) NO: K151813(Special)
ATTN: Ronald K Smith              PHONE NO : 203 9449494 
3 ENTERPRISE DRIVE, SUITE 210     SE DECISION MADE: 31-JUL-15
SHELTON CT  06484                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Atlas SPEEDER Header/Neck
Quality Electrodynamics, LLC      510(k) NO: K151829(Traditional)
ATTN: KATHLEEN  ARAS              PHONE NO : 1 440 4842964 
700 Beta Drive Suite 100          SE DECISION MADE: 29-JUL-15
Mayfield Village OH  44143        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: 3MP (X213C3P0E,  X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display
D-VIEW DISPLAY TECHNOLOGY CO., LTD510(k) NO: K151854(Traditional)
ATTN: JIANFEI  SUN                PHONE NO : 8610 823 79533 5360
3F, BUILDING 4, NO.12# KECHUANG 13SE DECISION MADE: 28-JUL-15
BEI JING  CN 100176               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Caiman Seal and Cut Technology
Aesculap, Inc.                    510(k) NO: K151858(Special)
ATTN: Denise  Adams               PHONE NO : 610 9849076 
3773 Corporate Parkway            SE DECISION MADE: 21-JUL-15
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: 5MP Monochrome LCD Monitor, RadiForce GX540
EIZO CORPORATION                  510(k) NO: K151883(Traditional)
ATTN: HIROAKI  HASHIMOTO          PHONE NO : 81 76 2742468 
153 SHIMOKASHIWANO                SE DECISION MADE: 30-JUL-15
HAKUSAN  JP 924-8566              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Infinity ERCP Sampling Device
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K151889(Special)
ATTN: CARROLL  MARTIN             PHONE NO : 440 3586259 
5976 HEISLEY ROAD                 SE DECISION MADE: 30-JUL-15
MENTOR OH  44060                  510(k) STATEMENT
                                                    
 
DEVICE: SyncVision System
VOLCANO CORPORATION               510(k) NO: K151904(Special)
ATTN: ELAINE  ALAN                PHONE NO : 858 7641281 
1 FORTUNE DR.                     SE DECISION MADE: 31-JUL-15
BILLERICA MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SmartSite Vented Vial Access Device
YUKON MEDICAL, LLC                510(k) NO: K151963(Third Party - Traditional)
ATTN: CARL  DUPPER                PHONE NO : 919 5958257 
4021 STIRRUP CREEK DRIVE SUITE200 SE DECISION MADE: 31-JUL-15
DURHAM NC  27703                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
 
                  TOTAL 510(k)s THIS PERIOD   271                                     
                  TOTAL WITH SUMMARIES        251                                     
                  TOTAL WITH STATEMENTS        20
                                      

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