Medical Devices

December 2015 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD December 2015
 
 
DEVICE: BONDEASE TOPICAL SKIN ADHESIVE
OPTMED, INC.                      510(k) NO: K141157(Traditional)
ATTN: STEPHANIE  RAIS             PHONE NO : 732 885-3955 
601 LEXINGTON AVENUE SUITE 5100   SE DECISION MADE: 22-DEC-15
NEW YORK NY  10022                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: New Medax Biopsy Systems
MEDAX SRL UNIPERSONALE            510(k) NO: K142125(Traditional)
ATTN: Stefano  Cavalieri          PHONE NO : 39 0386 522132 
VIA R. Piva 1/A                   SE DECISION MADE: 22-DEC-15
Poggio Rusco  IT 46025            510(k) STATEMENT
                                                    
 
DEVICE: OneQ-SL Implant System
DENTIS CO. LTD.                   510(k) NO: K142313(Traditional)
ATTN: Jeong Seop Keun             PHONE NO : 82 53583 2804 
#951, WORAM-DONG, DALSEO-GU       SE DECISION MADE: 10-DEC-15
DAEGU  KR 704-320                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PRODIGY iConnect Blood Glucose Monitoring System
OK BIOTECH CO., LTD.              510(k) NO: K142785(Traditional)
ATTN: Jen  Ke-Min                 PHONE NO : 886 3 5160258 
No. 91, Sec. 2, Gongdao 5th Road  SE DECISION MADE: 17-DEC-15
Hsinchu City  TW 30070            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ADVIA Centaur Toxoplasma M (Toxo M)
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K142826(Traditional)
ATTN: Matthew  Gee                PHONE NO : 914 5242099 
511 BENEDICT AVENUE               SE DECISION MADE: 22-DEC-15
TARRYTOWN NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BTM Wound Dressing
POLYNOVO BIOMATERIALS PTY LTD     510(k) NO: K142879(Traditional)
ATTN: Philip  Powell              PHONE NO : 61 38681 4055 
UNIT 2, 320 LORIMER STREET        SE DECISION MADE: 23-DEC-15
PORT MELBOURNE  AU 3207           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Spinal Inner Fixation System
Changzhou Dingjian Medical Applian510(k) NO: K143013(Traditional)
ATTN: Li  Quinsong                PHONE NO : 0086 135 84330156 
No.19 Juxiang Road, Wujin EconomicSE DECISION MADE: 11-DEC-15
Changzhou   CN 213149             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FIREFLY Pedicle Screw Navigation Guide
Mighty Oak Medical Inc            510(k) NO: K143222(Traditional)
ATTN: Heidi  Frey                 PHONE NO : 720 3989703 
777 E Girard Ave. STE 150         SE DECISION MADE: 11-DEC-15
Englewood CO  80113               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Panther StereoSeed
PROWESS, INC.                     510(k) NO: K143514(Traditional)
ATTN: Rachel  Scarano             PHONE NO : 925 3560360 
1844 CLAYTON ROAD                 SE DECISION MADE: 11-DEC-15
CONCORD CA  94520                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Reaxon Plus
MEDOVENT GMBH                     510(k) NO: K143711(Traditional)
ATTN: THOMAS  FREIER              PHONE NO : 49 61316 17690 
FRIEDRICH-KOENIG-STR. 3           SE DECISION MADE: 02-DEC-15
MAINZ  DE 55129                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Regenomer® Syringe, Regenomer® Plug, Regenomer® Block
NIBEC CO, LTD                     510(k) NO: K150079(Abbreviated)
ATTN: YOON-JEONG  PARK            PHONE NO : 82 10 28898590 
IWOL ELECTRICITY-ELECTRONIC AGRO-ISE DECISION MADE: 10-DEC-15
JINCHEON-GUN  KR 365-824          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Liquichek Cardiac Markers Plus Control LT
Bio-Rad Laboratories              510(k) NO: K150300(Traditional)
ATTN: Elizabeth   Platt           PHONE NO : 949 5981285 
9500 Jeronimo Road                SE DECISION MADE: 11-DEC-15
Irvine CA  92618-2017             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PAPAYA 3D Plus
GENORAY CO., LTD.                 510(k) NO: K150354(Traditional)
ATTN: Kyoung-hwa  Kim             PHONE NO : 82 3173 74100 
512 BYUCKSAN TECHNOPIA 434-6 SANGDSE DECISION MADE: 10-DEC-15
SEONGNAM-CITY  KR 462-716         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: V-STEADY, V-FAST
G21 S.R.L.                        510(k) NO: K150408(Traditional)
ATTN: MAURIZIO  FORONI            PHONE NO : 39 0535 30312 
VIA SANDRO PERTINI, 8             SE DECISION MADE: 14-DEC-15
SAN POSSIDONIO  IT 41039          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology
Surgical Instrument Services and S510(k) NO: K150524(Traditional)
ATTN: Richard D Wynkoop           PHONE NO : 541 9233310 
(dba Medline ReNewal) 2747 SW 6th SE DECISION MADE: 16-DEC-15
Redmond OR  97756                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Ascent 3D
CAO GROUP, INC.                   510(k) NO: K150585(Abbreviated)
ATTN: Robert K Larsen             PHONE NO : 1 801 2569282 
4628 WEST SKYHAWK DRIVE           SE DECISION MADE: 31-DEC-15
WEST JORDAN UT  84084             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: RX-FIX Mini Rail External Fixator
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K150640(Traditional)
ATTN: LESLIE  FITCH               PHONE NO : 901 8674120 
1023 Cherry Road                  SE DECISION MADE: 01-DEC-15
Memphis TN  38111                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NeoLas
SHEAUMANN LASER, INC              510(k) NO: K150664(Traditional)
ATTN: Katina  Sousa               PHONE NO : 508 9700600 
45 Bartlett Street                SE DECISION MADE: 22-DEC-15
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Biodesign Enterocutaneous Fistula Plug
COOK BIOTECH INCORPRATED          510(k) NO: K150668(Traditional)
ATTN: Perry W Guinn               PHONE NO : 1 765 4973355 
1425 INNOVATION PLACE             SE DECISION MADE: 09-DEC-15
WEST LAFAYETTE IN  47906          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: L-Mesitran Dressing Family II- Soft and Tulle
Theo Manufacturing BV             510(k) NO: K150676(Traditional)
ATTN: Monique  Gottgens           PHONE NO : 31 43 3251773 
Capucijnenstraat 71               SE DECISION MADE: 23-DEC-15
Maastricht  NL 6211 RP            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CUSA Excel+
INTEGRA LIFESCIENCES CORP.        510(k) NO: K150682(Traditional)
ATTN: JENNIFER  SIEGEL            PHONE NO : 609 9036022 
311 ENTERPRISE DR.                SE DECISION MADE: 18-DEC-15
PLAINSBORO NJ  08536              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine
FRESENIUS MEDICAL CARE RENAL THERA510(k) NO: K150708(Traditional)
ATTN: DENISE  OPPERMANN           PHONE NO : 1 781 6994479 
920 Winter Street                 SE DECISION MADE: 10-DEC-15
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Varaya Sport
VARAYA PHOTOCEUTICALS, LLC        510(k) NO: K150716(Traditional)
ATTN: Myk  Lum                    PHONE NO : 949 7531482 
16511 SCIENTIFIC WAY SUITE 200    SE DECISION MADE: 08-DEC-15
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EnFocus 2300, EnFocus 4400
BIOPTIGEN, INC.                   510(k) NO: K150722(Traditional)
ATTN: Tammy B Carrea              PHONE NO : 919 5951260 
633 DAVIS DRIVE, SUITE 480        SE DECISION MADE: 02-DEC-15
MORRISVILLE NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SpectraShield 9500 Surgical N95 Respirator
Nexera Medical Inc.               510(k) NO: K150729(Traditional)
ATTN: Paul  Sallarulo             PHONE NO : 954 4952020 
3343 West Commercial Blvd, Suite 1SE DECISION MADE: 29-DEC-15
Ft.Lauderdale FL  33309           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Flexipet Denuding Pipette, Flexipet Manipulation Pipette
COOK INCORPORATED                 510(k) NO: K150748(Traditional)
ATTN: NAOMI  FUNKHOUSER           PHONE NO : 812 3353575 104371
750 DANIELS WAY                   SE DECISION MADE: 18-DEC-15
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Cardinal Health Trochanteric IM Nail System
Cardinal Health                   510(k) NO: K150769(Traditional)
ATTN: Tatyana  Bogdan             PHONE NO : 1 847 8872325 
1500 WAUKEGAN RD.                 SE DECISION MADE: 14-DEC-15
WAUKEGAN IL  60085                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AbStats Gateway
GI Logic Inc                      510(k) NO: K150782(Traditional)
ATTN: James  Beeton               PHONE NO : 1 626 9932772 
909 East Green Street             SE DECISION MADE: 14-DEC-15
Pasadena CA  91106                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Universal Spike
B. Braun Medical Inc.             510(k) NO: K150787(Traditional)
ATTN: Tracy  Maddock              PHONE NO : 610 5962545 
901 Marcon Boulevard              SE DECISION MADE: 02-DEC-15
Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Next Science Wound Gel
NEXT SCIENCE, LLC                 510(k) NO: K150792(Traditional)
ATTN: MATTHEW  MYNTTI             PHONE NO : 1 855 5642762 
8130 BAYMEADOWS WAY WEST, SUITE 20SE DECISION MADE: 17-DEC-15
JACKSONVILLE FL  33256            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PulseFlowDF
PulseFlow Technologies            510(k) NO: K150806(Traditional)
ATTN: Les  Lindsay                PHONE NO : 011 447966 321001 
Midshires House Midshires BusinessSE DECISION MADE: 16-DEC-15
Aylesbury  GB hp19 8hl            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit
Becton, Dickinson and Company     510(k) NO: K150815(Traditional)
ATTN: Catherine(Katie)  Bessette  PHONE NO : 408 9544109 
2350 Qume Dr.                     SE DECISION MADE: 17-DEC-15
San Jose CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Dario Blood Glucose Monitoring System
LabStyle Innovations Ltd.         510(k) NO: K150817(Traditional)
ATTN: TRACEY  WIELINSKI           PHONE NO : 440 9155833 
3521 HATWYNN RD.                  SE DECISION MADE: 21-DEC-15
CHARLOTTE NC  28269               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: O-RING Condom
O-RING Products LLC               510(k) NO: K150828(Abbreviated)
ATTN: William  Mistler            PHONE NO : 440 7316430 
4012 Grand Manor Court, #208      SE DECISION MADE: 18-DEC-15
Raleigh NC  27612                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Cellvizio 100 Series System with Confocal Miniprobes
MAUNA KEA TECHNOLOGIES            510(k) NO: K150831(Traditional)
ATTN: Sophie  Rehault             PHONE NO : 33  170080994 
9, RUE D'ENGHIEN                  SE DECISION MADE: 22-DEC-15
PARIS  FR F-75010                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System
ANDON HEALTH CO.,LTD              510(k) NO: K150833(Traditional)
ATTN: Yi  Liu                     PHONE NO : 86 226052 6161 
NO 3,  JINPING RD, YA AN ST NANKAISE DECISION MADE: 04-DEC-15
TIANJIN  CN 300193                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant
LACLEDE, INC.                     510(k) NO: K150841(Traditional)
ATTN: Michael  Pellico            PHONE NO : 1 310 6054280 
2103 EAST UNIVERSITY DR.          SE DECISION MADE: 29-DEC-15
RANCHO DOMINQUEZ CA  90220        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut
PHADIA AB                         510(k) NO: K150854(Traditional)
ATTN: Carina  Magnusson           PHONE NO : 46 18 165000 
RAPSGATAN 7P                      SE DECISION MADE: 14-DEC-15
UPPSALA   SE 75137                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Checkme Pro Health Monitor
Viatom Technology Co., Ltd.       510(k) NO: K150869(Traditional)
ATTN: Zhou  Saixin                PHONE NO : 86 755 86638929 
C607,Languang Park, No. 7 Xinxi RoSE DECISION MADE: 10-DEC-15
Nanshan, Shenzhen  CN 518057      510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: HydroPearl Microspheres, HydroPearl Microspheres
MICROVENTION, INC.                510(k) NO: K150870(Traditional)
ATTN: NAOMI  GONG                 PHONE NO : 714 2478055 
1311 VALENCIA AVE                 SE DECISION MADE: 21-DEC-15
TUSTIN CA  92780                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
Instrumentation Laboratory Co.    510(k) NO: K150877(Traditional)
ATTN: Carol  Marble               PHONE NO : 781 8614467 
180 Hartwell Road                 SE DECISION MADE: 13-DEC-15
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm
MOLLER MEDICAL GMBH               510(k) NO: K150898(Traditional)
ATTN: JULIANE  DRAGON             PHONE NO : 49 661 941950 
WASSERKUPPENSTR.29-31             SE DECISION MADE: 18-DEC-15
FULDA  DE 36043                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: XM-01 Electronic Automatic Blood Pressure Monitor
Sky Innovation Technology ( Shangh510(k) NO: K150908(Traditional)
ATTN: Charles  Shen               PHONE NO : 086 400 9999523 
9th Floor Hechuan Building, 2016 YSE DECISION MADE: 16-DEC-15
Shanghai  CN 201103               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Deployable Oxygen Generation System-Smaill (DOGS-S)
AirSep Corporation                510(k) NO: K150930(Traditional)
ATTN: Peter  Weisenborn           PHONE NO : 716 6910202 6209
260 Creekside Drive               SE DECISION MADE: 18-DEC-15
Buffalo NY  14228                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MReye Embolization Coils
Cook Incorporated                 510(k) NO: K150931(Traditional)
ATTN: Nozomi  Yagi                PHONE NO : 812 3353575 104511
750 Daniels Way                   SE DECISION MADE: 18-DEC-15
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Powder Free Vinyl Patient Examination Glove (Non?-Sterile)
LPL (HUI ZHOU) GLOVE              510(k) NO: K150934(Traditional)
ATTN: LEE  HONG CHONG             PHONE NO : 86 752 6863391 
DAXIAOTANG VILLAGE, LUOYANG TOWN BSE DECISION MADE: 21-DEC-15
HUIZHOU CITY  CN 516120           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FreezeKit Cleave , ThawKit Cleave
VITROLIFE SWEDEN AB               510(k) NO: K150950(Traditional)
ATTN: Brett Sonet Glazar          PHONE NO : 720 4735577 
3601 SOUTH INCA STREET            SE DECISION MADE: 21-DEC-15
ENGLEWOOD CO  80110               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EmbryoSlide Culture Dish
VITROLIFE A/S                     510(k) NO: K150961(Traditional)
ATTN: BELINDA  DUEHOLM            PHONE NO : 45 2076 3707 
JENS JUULS VEJ 20                 SE DECISION MADE: 04-DEC-15
VIBY J  DK DK-8260                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MReye Flipper Detachable Embolization Coil and Delivery System
Cook Incorporated                 510(k) NO: K150964(Traditional)
ATTN: Nozomi  Yagi                PHONE NO : 812 3353575 104511
750 Daniels Way                   SE DECISION MADE: 18-DEC-15
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: HMB32
HAEMOPHARM BIOFLUIDS SRL          510(k) NO: K150966(Traditional)
ATTN: GIUSEPPE  TOMASINI          PHONE NO : 39 535 29323 
VIA DELL'INDUSTRIA 6              SE DECISION MADE: 04-DEC-15
TOVO S. AGATA  IT 23030           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Vios Monitoring System
VIOS MEDICAL, INC.                510(k) NO: K150992(Traditional)
ATTN: MEGAN  GRAHAM               PHONE NO : 651 7648467 
7300 HUDSON BLVD N, STE 140       SE DECISION MADE: 16-DEC-15
ST. PAUL MN  55128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: RUBY STAR
BISON MEDICAL CO., LTD            510(k) NO: K150997(Traditional)
ATTN: SUN-WOO  LEE                PHONE NO : 82 2 8657121 
371-42 GASANDONG,                 SE DECISION MADE: 22-DEC-15
GUEMCHEON GU  KP 153-803          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Intraluminal Applicator Set
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K151022(Traditional)
ATTN: PETER J. CORONADO           PHONE NO : 650 4246320 
911 HANSEN WAY                    SE DECISION MADE: 17-DEC-15
PALO ALTO CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: iHearTest
IHEAR MEDICAL, INC.               510(k) NO: K151025(Traditional)
ATTN: ANGELA LEE FOREMAN          PHONE NO : 510 2764437 
15250 HESPERIAN BLVD, STE #102    SE DECISION MADE: 29-DEC-15
SAN LEANDRO CA  94578             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Pacifier Activated Lullaby (PAL®)
Power Medical Devices, LLC        510(k) NO: K151050(Traditional)
ATTN: Patricia  Palmer            PHONE NO : 917 6961190 
1615 S.Congress Ave, Ste 13       SE DECISION MADE: 22-DEC-15
Delray Beach FL  33445            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: WASTON Metallic Intramedullary Nail System
CHANGZHOU WASTON MEDICAL APPLIANCE510(k) NO: K151062(Traditional)
ATTN: Jack  Lu                    PHONE NO : 86 519 86522226 
9 Xihu Road, Wujin Hi-tech IndustrSE DECISION MADE: 17-DEC-15
Changzhou  CN 213168              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Monitor B40
GE MEDICAL SYSTEMS CHINA CO., LTD.510(k) NO: K151063(Special)
ATTN: Sun  YanLi                  PHONE NO : 86 510 85278232 
NO. 19 CHANGJIANG ROAD, NATIONAL HSE DECISION MADE: 15-DEC-15
WUXI  CN 214028                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Magnetic Reasonance Imaging System 
JIANGSU MAGSPIN INSTRUMENT CO.,LTD510(k) NO: K151074(Traditional)
ATTN: LEO  LI                     PHONE NO : 86 512 36690072 
BUILDING 9, NO.299, YUYANG ROAD   SE DECISION MADE: 22-DEC-15
KUNSHAN   CN 215300               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Medismart ( Latex Surgeon¿s Gloves powdered ) and  Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein
ST.MARYS RUBBERS PVT. LTD.        510(k) NO: K151114(Abbreviated)
ATTN: Srinivasan.  S              PHONE NO : 91 4828 252277 
Koovappally P.O.Kanjirappally     SE DECISION MADE: 11-DEC-15
Kottayam District, Kerala  IN 6865510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Foresight Intracardiac Echocardiography (ICE) System 
Colibri Technologies Inc.         510(k) NO: K151126(Traditional)
ATTN: SAM  MOSTAFAVI              PHONE NO : 416 4830100 
293 Lesmill Road                  SE DECISION MADE: 18-DEC-15
Toronto  CA M3B 2V1               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: higi Station
higi SH LLC                       510(k) NO: K151127(Traditional)
ATTN: Colin  Hill                 PHONE NO : 626 8645635 
717 S Myrtle Ave Suite A          SE DECISION MADE: 08-DEC-15
Monrovia CA  91016                510(k) STATEMENT
                                                    
 
DEVICE: PENTRA XLR
HORIBA ABX SAS                    510(k) NO: K151133(Traditional)
ATTN: Caroline  Ferrer            PHONE NO : 33 467 141516 
PARC EUROMEDECINE RUE DU CADUCEE, SE DECISION MADE: 09-DEC-15
MONTPELLIER Cedex 4  FR 34184     510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ALP VasQcare Take Home System
Currie Medical Specialties, Inc.  510(k) NO: K151158(Traditional)
ATTN: Owen J Bry                  PHONE NO : 909 9120900 
8758 Hellman Ave                  SE DECISION MADE: 10-DEC-15
Rancho Cucamonga CA  91730        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Nexodyn AOS Wound Care Solution
APR Applied Pharma Research SA    510(k) NO: K151168(Traditional)
ATTN: Giorgio  Reiner             PHONE NO : 41 91695 7020 
Via Corti 5                       SE DECISION MADE: 22-DEC-15
Balerna  CH 6828                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, Xpert Mid-turbinate Adult Sample Collection Kit, GeneXpert Xpress System (GX-I)
CEPHEID                           510(k) NO: K151226(Dual Track)
ATTN: Kerry J Flom                PHONE NO : 408 4008460 
904 CARIBBEAN DRIVE               SE DECISION MADE: 03-DEC-15
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Navigator Aesthetic Delivery System
CARTICEPT MEDICAL INC             510(k) NO: K151255(Traditional)
ATTN: CARRIBETH  RAMEY            PHONE NO : 1 770 7543800 
6120 WINDWARD PRKWY SUITE 220     SE DECISION MADE: 30-DEC-15
ALPHARETTA GA  30005              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Counter OTC TENS Device, Model CSD-737Z
COUNTER SCIENTIFIC DEVELOPMENT (GZ510(k) NO: K151279(Traditional)
ATTN: Jiang  Eagle                PHONE NO : 86 20 38289980 
2ND &3RD FLOOR, BLD. 6, DAPIAN INDSE DECISION MADE: 16-DEC-15
GUANGZHOU  CN 510665              510(k) STATEMENT
                                                    
 
DEVICE: Electric Double Breast Pumps
Wuxi Xinzhongrui Baby Supplies Co.510(k) NO: K151284(Traditional)
ATTN: Shaozhong  Chen             PHONE NO : 86 510 81155228 
NO.117 XINHUA ROAD, MEICUN, NEW DISE DECISION MADE: 21-DEC-15
WUXI   CN 214115                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Biodenta Customized Abutment - Titanium 
BIODENTA SWISS AG                 510(k) NO: K151295(Traditional)
ATTN: DAVID   ELIER               PHONE NO : 41 71 7471111 
TRAMSTRASSE 16                    SE DECISION MADE: 01-DEC-15
BERNECK  CH 9442                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: D-100 HbA1c, D-100 HbA1c Calibrator Pack
Bio-Rad Laboratories, Inc.        510(k) NO: K151321(Traditional)
ATTN: Jackie  Buckley             PHONE NO : 510 7415309 
4000 Alfred Nobel Dr.             SE DECISION MADE: 09-DEC-15
Hercules CA  94547                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet
SENTEC AG                         510(k) NO: K151329(Traditional)
ATTN: ANKE  WEISBRICH             PHONE NO : 41 61726 9760
RINGSTRASSE 39                    SE DECISION MADE: 17-DEC-15
THERWIL  CH 4106                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ROSA Brain 
MEDTECH S.A.                      510(k) NO: K151359(Traditional)
ATTN: MICHAEL  CHRIST             PHONE NO : 33 0467 107740 
ZAC EUREKA - 900 RUE DU MAS DE VERSE DECISION MADE: 18-DEC-15
MONTPELLIER  FR 34000             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Intellijoint HIP(tm) System
INTELLIJOINT SURGICAL INC.        510(k) NO: K151364(Traditional)
ATTN: BRANDON  GINGRICH           PHONE NO : 1 519 3423178 
60 BATHURST DR., UNIT 1           SE DECISION MADE: 28-DEC-15
WATERLOO  CA N2V 2A9              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: UV Lamps for Indoor Tanning Devices
LIGHT SOURCES, INC.               510(k) NO: K151370(Traditional)
ATTN: EUGENE  CZAKO               PHONE NO : 203 7997877 
37 ROBINSON BLVD                  SE DECISION MADE: 17-DEC-15
ORANGE CT  06477                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye
Covidien                          510(k) NO: K151381(Traditional)
ATTN: Danielle  Mueller           PHONE NO : 303 3052603 
6135 Gunbarrel Ave                SE DECISION MADE: 11-DEC-15
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MIVI Mi-AXUS Guide Catheter
MIVI NEUROSCIENCE, INC            510(k) NO: K151396(Traditional)
ATTN: Matthew   Ogle              PHONE NO : 612 3817674 
6545 City West Parkway            SE DECISION MADE: 09-DEC-15
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Always/Tampax bladder supports
PROCTER & GAMBLE                  510(k) NO: K151413(Traditional)
ATTN: LENORE  FAULHABER           PHONE NO : 513 6342466 
6110 CENTER HILL AVE.             SE DECISION MADE: 18-DEC-15
CINCINNATI OH  45224              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Cardinal Health Sterilization Wrap
CARDINAL HEALTH 200, LLC          510(k) NO: K151445(Traditional)
ATTN: MEGAN  MIDDAUGH             PHONE NO : 847 8876812 
1500 WAUKEGAN ROAD                SE DECISION MADE: 21-DEC-15
WAUKEGAN IL  60085                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Sahara Stabilization System
K2M, INC                          510(k) NO: K151481(Traditional)
ATTN: NANCY  GIEZEN               PHONE NO : 571 9192168 
751 MILLER DRIVE SE               SE DECISION MADE: 21-DEC-15
LEESBURG VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Latitude-C Cervical Interbody Spacer System
Degen Medical                     510(k) NO: K151496(Traditional)
ATTN: Craig  Black                PHONE NO : 843 9924551 
1321-C North Cashua Drive         SE DECISION MADE: 15-DEC-15
Florence SC  29501                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Breathing circuit bacterial/viral filter
ZHEJIANG HAISHENG MEDICAL DEVICE C510(k) NO: K151498(Traditional)
ATTN: HU  JUBIN                   PHONE NO : 86 575 88158510 
305#TANGGONG ROAD, PAOJIANG INDUSTSE DECISION MADE: 18-DEC-15
SHAOXING  CN 312071               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ENDOPLUS hand-held laparoscopic instruments
ENDOPLUS                          510(k) NO: K151567(Traditional)
ATTN: Matthew  Gudeman            PHONE NO : 800 2365972 
750 Tower Road, Suite A           SE DECISION MADE: 23-DEC-15
Mundelein IL  60060               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OneTouch Ultra Plus Flex Blood Glucose Monitoring System
LIFESCAN EUROPE                   510(k) NO: K151611(Traditional)
ATTN: NIKI  SKELLY                PHONE NO : 441 463 721652 
GUBELSTRASSE 34                   SE DECISION MADE: 14-DEC-15
ZUG  CH CH-6300                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ABL80 FLEX and ABL80 FLEX CO-OX
SENDX MEDICAL INC                 510(k) NO: K151639(Traditional)
ATTN: VIBEKE  AGERLIN             PHONE NO : 760 9306300 
1945 PALOMAR OAKS WAY             SE DECISION MADE: 07-DEC-15
CARLSBAD CA  92011                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Gmate Origin Blood Glucose Monitoring System
PHILOSYS, INC.                    510(k) NO: K151658(Traditional)
ATTN: LINDA  CHAN                 PHONE NO : 908 5051649 
304 PARK AVENUE SOUTH, SUITE 218  SE DECISION MADE: 01-DEC-15
NEW YORK NY  10016                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Cerner CareAware Event Management
CERNER CORPORATION                510(k) NO: K151672(Traditional)
ATTN: SHELLEY S. LOOBY            PHONE NO : 1 816 2011368 
2800 ROCKCREEK PKWY.              SE DECISION MADE: 21-DEC-15
KANSAS CITY MO  64117             510(k) STATEMENT
                                                    
 
DEVICE: HumanPen Ergo II
ELI LILLY AND COMPANY, INC.       510(k) NO: K151686(Traditional)
ATTN: CHRISTINE A. PHILLIPS       PHONE NO : 1 317 2767239 
LILLY CORPORATE CENTER            SE DECISION MADE: 30-DEC-15
INDIANAPOLIS IN  46285            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BEAUTIFIL II Enamel
SHOFU DENTAL CORPORATION          510(k) NO: K151699(Traditional)
ATTN: Mauro  Malyzyner            PHONE NO : 760 7363277 
1225 STONE DRIVE                  SE DECISION MADE: 10-DEC-15
SAN MARCOS CA  92078              510(k) STATEMENT
                                                    
 
DEVICE: Disposable Endoscope Valves Set A
WILSON INSTRUMENTS (SHANGHAI) COMP510(k) NO: K151714(Traditional)
ATTN: LIJUAN  ZHANG               PHONE NO : 86 021 39290005 
BUILDING 5, NO. 258 SHUANGBANG ROASE DECISION MADE: 03-DEC-15
SHANGHAI  CN 201702               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PediatrOS RigidTack/FlexTack
MERETE MEDICAL GMBH               510(k) NO: K151762(Traditional)
ATTN: EMMANUEL  ANAPLIOTIS        PHONE NO : 49 30 779980114 
ALT-LANKWITZ 102                  SE DECISION MADE: 28-DEC-15
BERLIN  DE 12247                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K151767(Traditional)
ATTN: Laura J. Duggan             PHONE NO : 302 6317654 
500 GBC DRIVE  PO BOX 6101 MS 514 SE DECISION MADE: 11-DEC-15
NEWARK DE  19711                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Bpump Blood Pressure Cuff
SHENZHEN PUMP MEDICAL SYSTEM CO., 510(k) NO: K151810(Traditional)
ATTN: XIE  QIONGYU                PHONE NO : 086 0755 26710795 
2/F, M-7 SINOSTEEL BUILDING, MAQUESE DECISION MADE: 17-DEC-15
NANSHAN DISTRICT, SHENZHEN  CN 518510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SERVO-U Ventilator System, SERVO-n Ventilator System
MAQUET CRITICAL CARE AB           510(k) NO: K151814(Traditional)
ATTN: MARIA VON BAHR              PHONE NO : 011 46 87307300 
RONTGENVAGEN 2                    SE DECISION MADE: 21-DEC-15
SOLNA  SE SE-171 54               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
Boston Scientific Corporation     510(k) NO: K151840(Traditional)
ATTN: Nikki M Wahlberg            PHONE NO : 763 4942381 
One Scimed Place                  SE DECISION MADE: 16-DEC-15
Maple Grove MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Bio2 Fusion Implant System
Bio2 Technologies, Inc            510(k) NO: K151876(Traditional)
ATTN: Janet  Krevolin             PHONE NO : 781 8690559 
12R Cabot Road                    SE DECISION MADE: 30-DEC-15
Woburn MA  01801                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Video Colposcope 
EDAN INSTRUMENTS, INC.            510(k) NO: K151878(Traditional)
ATTN: Queena  Chen                PHONE NO : 86 75526 858736 
3/F- B, Nanshan Medical EquipmentsSE DECISION MADE: 01-DEC-15
Shenzhen  CN 518067               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Medical Diode Laser Systems
Wuhan Gigaa Optronics Technology C510(k) NO: K151890(Traditional)
ATTN: Nie  Xinxing                PHONE NO : 86 27 67848871 8045
5,6/f, Unit A, B, Building B8,  HiSE DECISION MADE: 23-DEC-15
#818 Gaoxin Ave, East Lake Develop510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Houdini Catheter
Cruzar Medsystems, Inc.           510(k) NO: K151896(Traditional)
ATTN: Tom  Kramer                 PHONE NO : 781 2230508 
50 Braintree Hill Office Park, SuiSE DECISION MADE: 07-DEC-15
Braintree MA  02184               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VariLift-L Interbody Fusion Device
WENZEL SPINE, INC.                510(k) NO: K151900(Traditional)
ATTN: BECKINAM  NOWATZKE          PHONE NO : 1 512 3148271 
206 WILD BASIN RD, BLDG A, STE 203SE DECISION MADE: 11-DEC-15
AUSTIN TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables
ZIMMER, INC.                      510(k) NO: K151907(Traditional)
ATTN: PATRICK  MCCULLAGH          PHONE NO : 574 3724656 
P.O. BOX 708                      SE DECISION MADE: 30-DEC-15
WARSAW IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: TRI Dental Implant System
TRI DENTAL IMPLANTS INT. AG       510(k) NO: K151916(Traditional)
ATTN: SANDRO   VENANZONI          PHONE NO : 41 32 5101606 
LINDENSTRASSE 14                  SE DECISION MADE: 18-DEC-15
BAAR  CH CH-6340                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: QuickRay HD Intraoral Sensor
DENTERPRISE INTERNATIONAL, INC.   510(k) NO: K151926(Traditional)
ATTN: CLAUDE  BERTHOIN            PHONE NO : 1 386 6720450 
100 EAST GRANADA BLVD SUITE 219   SE DECISION MADE: 14-DEC-15
ORMOND BEACH FL  32176            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BRX PRO Bruxism Guard
12TH MAN TECHNOLOGIES, INC.       510(k) NO: K151933(Traditional)
ATTN: ALEX  STENZLER              PHONE NO : 1 714 7054576 
7245 GARDEN GROVE BLVD.,  SUITE C SE DECISION MADE: 10-DEC-15
GARDEN GROVE CA  92841            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ROI-C Titanium-Coated Implant System
LDR SPINE USA                     510(k) NO: K151934(Traditional)
ATTN: JAMES  WILSON               PHONE NO : 512 3443333 
13785 RESEARCH BOULEVARD, SUITE 20SE DECISION MADE: 07-DEC-15
AUSTIN TX  78750                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle
SYNAPTIC MEDICAL LIMITED          510(k) NO: K151936(Traditional)
ATTN: Yang  Tiecheng              PHONE NO : 86 105 1297209813 
BUILDING C, 100 KECHUANG 6TH STREESE DECISION MADE: 04-DEC-15
BEIJING  CN 101111                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Safelock Disposable Blood Collection Set, Disposable Blood Collection Set
JIANGYIN CAINA TECHNOLOGY CO., LTD510(k) NO: K151991(Traditional)
ATTN: JUN  LU                     PHONE NO : 86 510 86205183 
NO.2, TAIFU ROAD, HUASHI TOWN     SE DECISION MADE: 11-DEC-15
JIANGYIN  CN 214421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Sterile Repositionable Hemostasis Clipping Device
Micro-Tech (Nanjing) CO.,Ltd.     510(k) NO: K152001(Traditional)
ATTN: Becky  Li                   PHONE NO : 86 25 58646378 
No. 10 Gaoke Third Road           SE DECISION MADE: 10-DEC-15
Nanjing  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EVO platform
Quanta System SpA                 510(k) NO: K152012(Traditional)
ATTN: Francesco  Dell'Antonio     PHONE NO : 39 0331 376797 
Via IV Novembre, 116              SE DECISION MADE: 08-DEC-15
Solbiate Olona (Va)  IT 21058     510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MammoGRIP
Women's Imaging Solutions Enterpri510(k) NO: K152038(Traditional)
ATTN: Nancy  DeRobertis           PHONE NO : 201 6000463 
226 Wilson Drive                  SE DECISION MADE: 22-DEC-15
Cresskill NJ  07626               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid
ASCENSION ORTHOPEDICS             510(k) NO: K152047(Traditional)
ATTN: WILLIAM  GARZON             PHONE NO : 512 5968908 
8700 CAMERON ROAD, SUITE 100      SE DECISION MADE: 23-DEC-15
AUSTIN TX  78754                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: 3M Attest Rapid Readout Biological Indicator 1295
3M COMPANY                        510(k) NO: K152060(Traditional)
ATTN: MATT  MORTENSEN             PHONE NO : 651 7372670 
3M CENTER, BUILDING 275-5W-06     SE DECISION MADE: 01-DEC-15
ST. PAUL MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Implant Studio 2015
3Shape Medical A/S                510(k) NO: K152078(Traditional)
ATTN: Hanne  Nielsen              PHONE NO : 45 7027 2620 
Holmens Kanal 7                   SE DECISION MADE: 04-DEC-15
Copenhagen  DK DK-1060            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VisualEyes
INTERACOUSTICS A/S                510(k) NO: K152112(Traditional)
ATTN: ERIK  NIELSEN               PHONE NO : 45 6371 3555 
AUDIOMETER ALLE 1                 SE DECISION MADE: 29-DEC-15
MIDDELFART  DK 5500               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Renew NCP-5 External Counterpulsation System 
Stage 2 Innovations               510(k) NO: K152115(Traditional)
ATTN: Richard   Kotz              PHONE NO : 240 4728154 
7811 Montrose Rd                  SE DECISION MADE: 17-DEC-15
Rockville MD  20854               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Zenostar MT, Zenostar Color Liquids
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K152118(Traditional)
ATTN: BETINA  KISTNER             PHONE NO : 49 72 3137050 
LINDERSTRASSE 2                   SE DECISION MADE: 16-DEC-15
PFOZHEIM   DE 75179               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NuVent EM Sinus Dilation System
MEDTRONIC XOMED, INC.             510(k) NO: K152121(Traditional)
ATTN: Gabriela  Anchondo          PHONE NO : 904 2797550 
6743 SOUTHPOINT DRIVE NORTH       SE DECISION MADE: 01-DEC-15
JACKSONVILLE FL  32216            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: 2-in-1 Abdominal Muscle Training & Back Pain Relief System 
Tohkai Precision Electrical Manufa510(k) NO: K152128(Traditional)
ATTN: Yuk Wing Li                 PHONE NO : 86 755 27173101 
No.3 Alley 1, Second Industrial PaSE DECISION MADE: 23-DEC-15
Shenzhen  CN 518132               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Vital Connect Platform, HealthPatch MD, VitalPatch
VITAL CONNECT, INC.               510(k) NO: K152139(Traditional)
ATTN: BONNIE  WU                  PHONE NO : 1 408 9634620 
900 E. HAMILTON AVENUE, SUITE 500 SE DECISION MADE: 06-DEC-15
CAMPBELL CA  95008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OsteoMed ExtremiLOCK Wrist Plating System
OSTEOMED                          510(k) NO: K152145(Traditional)
ATTN: Piedad  Pena                PHONE NO : 972 6774600 
3885 Arapaho Rd                   SE DECISION MADE: 21-DEC-15
ADDISON TX  75001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: High Speed Handpieces and Accessories
CODENT TECHNICAL INDUSTRY CO., LTD510(k) NO: K152146(Traditional)
ATTN: Chin-Ting  Wen              PHONE NO : 886 7 6955533 812
5F., No.90, Luke 5th Rd., Luzhu DiSE DECISION MADE: 08-DEC-15
Kaohsiung City  TW 82151          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: V8 Balloon Aortic Valvuloplasty Catheter
InterValve, Inc.                  510(k) NO: K152150(Traditional)
ATTN: Mark  Ungs                  PHONE NO : 612 5991795 
2445 Xenium Lane                  SE DECISION MADE: 18-DEC-15
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MicroSpot Handpiece
ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K152153(Traditional)
ATTN: ANTJE  KATZER               PHONE NO : 49 3641 7700309 
BRUESSELER STR. 10                SE DECISION MADE: 11-DEC-15
JENA  DE 07747                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ARCHITECT 2nd Generation Testosterone
Abbott Laboratories               510(k) NO: K152155(Traditional)
ATTN: Regina Xavier Kumar         PHONE NO : 224 6688093 
100 Abbott Park Rd, Dept. 093G, BlSE DECISION MADE: 17-DEC-15
Abbott Park IL  60064             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LC Bead LUMI
BIOCOMPATIBLES UK LTD             510(k) NO: K152157(Traditional)
ATTN: April  Kent                 PHONE NO : 44 01252 732732 
Chapman House, Farnham Business PaSE DECISION MADE: 11-DEC-15
Farnham  GB GU9 8QL               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Myray- HYPERION X5
CEFLA S.C.                        510(k) NO: K152162(Traditional)
ATTN: Silvia  Sansavini           PHONE NO : 39 542 653438 
VIA SELICE PROVINCIALE 23/A       SE DECISION MADE: 24-DEC-15
IMOLA  IT 40026                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Econsole1
DRTECH CORPORATION                510(k) NO: K152172(Traditional)
ATTN: CHOUL-WOO  SHIN             PHONE NO : 82 31 7848856 
SUITE NO.2, 3 FLOOR, 29, DUNCHON-DSE DECISION MADE: 14-DEC-15
SEONGNAM-SI  KR 462-807           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Glidesheath
TERUMO MEDICAL CORPORATION        510(k) NO: K152173(Traditional)
ATTN: ERIN  DOYLE                 PHONE NO : 410 3927243 
950 ELKTON BLVD.                  SE DECISION MADE: 01-DEC-15
ELKTON MD  21921                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Upcera Dental Zirconia Blank for Aesthetic Restoration 
LIAONING UPCERA CO.,LTD           510(k) NO: K152175(Traditional)
ATTN: Charles   Shen              PHONE NO : 086 24 45565006 
NO.122 XIANGHUAI ROAD, ECONOMIC DESE DECISION MADE: 04-DEC-15
BENXI  CN 117004                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Fuse Gastroscopy System
ENDOCHOICE INC.                   510(k) NO: K152182(Special)
ATTN: DANIEL  HOEFER              PHONE NO : 888 6823636 
11810 WILLS RD.                   SE DECISION MADE: 10-DEC-15
ALPHARETTA GA  30009              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MedActive Oral Gel and Spray
MedActive Oral Pharmaceuticals, LL510(k) NO: K152201(Traditional)
ATTN: Brian  Walker               PHONE NO : 866 8874867 
1900 Gunn Highway                 SE DECISION MADE: 30-DEC-15
Odessa FL  33556                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm
TNI Manufacturing, Inc.           510(k) NO: K152202(Third Party - Traditional)
ATTN: Daniel   Sablyak            PHONE NO : 954 7425988 
4635 NW 103rd Avenue              SE DECISION MADE: 14-DEC-15
Sunrise FL  33351                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: PCT System
CENTINEL SPINE, INC.              510(k) NO: K152211(Traditional)
ATTN: JESSICA  STAUB              PHONE NO : 484 8878813 
900 AIRPORT ROAD, SUITE 3B        SE DECISION MADE: 01-DEC-15
WEST CHESTER PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PK AIM
GYRUS ACMI INC                    510(k) NO: K152219(Traditional)
ATTN: NEIL  KELLY                 PHONE NO : 508 8042690 
136 TURNPIKE ROAD                 SE DECISION MADE: 17-DEC-15
SOUTHBOROUGH MA  01772            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Zero-P Natural Plate System
Synthes (USA), LLC                510(k) NO: K152239(Traditional)
ATTN: Beth  Becotte               PHONE NO : 508 8383575 
1051 Synthes Ave                  SE DECISION MADE: 02-DEC-15
Monument CO  80132                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: One Coat 7 Universal
Coltene/Whaledent AG              510(k) NO: K152243(Traditional)
ATTN: Silke  Wallaschek           PHONE NO : 41 717575852 
Feldwiesentr.20                   SE DECISION MADE: 09-DEC-15
Altstatten  CH 9450               510(k) STATEMENT
                                                    
 
DEVICE: Remedy® Shoulder Spacer
Osteoremedies LLC                 510(k) NO: K152267(Traditional)
ATTN: Chris  Hughes               PHONE NO : 901 4533141 
6800 Poplar Avenue Suite 120      SE DECISION MADE: 15-DEC-15
Memphis TN  38138                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MAGNETOM Amira
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K152283(Traditional)
ATTN: CORDELL L FIELDS            PHONE NO : 610 2198518 
51 VALLEY STREAM PKWY.            SE DECISION MADE: 24-DEC-15
MALVERN PA  19355-1406            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS
COTTON HIGH TECH S.L.             510(k) NO: K152284(Traditional)
ATTN: Anna  Garcia                PHONE NO : 34 938391628 
Colonia La Rabeia s/n             SE DECISION MADE: 04-DEC-15
Barcelona  ES 08660               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Sterisheet Sterilization Wrap
ANDERSEN STERILIZERS, INC.        510(k) NO: K152291(Traditional)
ATTN: WILLIAM K ANDERSEN          PHONE NO : 336 3768622 
3154 CAROLINE DRIVE               SE DECISION MADE: 17-DEC-15
HAW RIVER NC  27258               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Respire Blue Series-EF
Respire Medical Holding           510(k) NO: K152292(Traditional)
ATTN: David  Walton               PHONE NO : 718 6437326 
18 Bridge Street Suite 4J         SE DECISION MADE: 07-DEC-15
Brooklyn NY  11201                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MotoBand¿ CP Implant System
CROSSROADS EXTREMITY SYSTEMS, LLC 510(k) NO: K152306(Traditional)
ATTN: VERNON  HARTDEGEN           PHONE NO : 901 2218406 
6055 PRIMACY PKWY SUITE 140       SE DECISION MADE: 11-DEC-15
MEMPHIS TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening
QFIX                              510(k) NO: K152321(Traditional)
ATTN: NADIA SOOKDEO HARHEN        PHONE NO : 610 2680585 
440 CHURCH ROAD                   SE DECISION MADE: 04-DEC-15
AVONDALE PA  19311                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Resolve 2.0
DENALI CORPORATION                510(k) NO: K152322(Traditional)
ATTN: Jan G Stannard              PHONE NO : 781 8269190 
134 OLD WASHINGTON STREET         SE DECISION MADE: 16-DEC-15
HANOVER MA  02339                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Disposable Infusion Needle, Safelock Disposable Infusion Needle
JIANGYIN CAINA TECHNOLOGY CO., LTD510(k) NO: K152323(Traditional)
ATTN: JUN  LU                     PHONE NO : 86 510 86205183 
NO. 2, TAIFU ROAD, HUASHI TOWN    SE DECISION MADE: 14-DEC-15
JIANGYIN  CN 214421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Biomet Microfixation OmniMax MMF System
BIOMET MICROFIXATION              510(k) NO: K152326(Traditional)
ATTN: LAUREN   JASPER             PHONE NO : 904 7419259 
1520 TRADEPORT DRIVE              SE DECISION MADE: 10-DEC-15
JACKSONVILLE FL  32218            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Expression MR400 MRI Patient Monitoring System
INVIVO CORPORATION                510(k) NO: K152330(Special)
ATTN: Rusty  Kelly                PHONE NO : 407 2520414 
12151 RESEARCH PARKWAY, SUITE 200 SE DECISION MADE: 23-DEC-15
ORLANDO FL  32826                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ViSi Mobile Monitoring System
SOTERA WIRELESS, INC              510(k) NO: K152341(Third Party - Traditional)
ATTN: Carson  Krupp               PHONE NO : 858 4274620 
10020 Huennekens Street           SE DECISION MADE: 14-DEC-15
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: Twin Peaks Lumbar Interbody Fusion System
SPINEWAY                          510(k) NO: K152355(Traditional)
ATTN: Julien  Thao my             PHONE NO : 33 0472770152 
7 ALLEE MOULIN BERGER             SE DECISION MADE: 10-DEC-15
ECULLY  FR 69130                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PRECICE Trauma Nail System
Ellipse Technologies Incorporated 510(k) NO: K152370(Special)
ATTN: John  McIntyre              PHONE NO : 949 8373600 
13900 Alton Parkway Ste 123       SE DECISION MADE: 22-DEC-15
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VITA VM LC Flow
VITA ZAHNFABRIK H. RAUTER GMBH & C510(k) NO: K152373(Abbreviated)
ATTN: Bernd  Walker               PHONE NO : 49 77 61562361 
Spitelgasse 3                     SE DECISION MADE: 30-DEC-15
Bad Sackingen  DE D-79713         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Digital Electrocardiograph
SHENZHEN BIOCARE BIO-MEDICAL EQUIP510(k) NO: K152384(Traditional)
ATTN: Hongbo  Zhong               PHONE NO : 86 755 3661533388 
Room A735, Floor 7,Tower A, No.168SE DECISION MADE: 18-DEC-15
Shenzhen  CN 519102               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K152386(Traditional)
ATTN: TINA  IP                    PHONE NO : 416 5934323 42338
439 UNIVERSITY AVENUE             SE DECISION MADE: 17-DEC-15
TORONTO  CA M5G 1Y8               510(k) STATEMENT
                                                    
 
DEVICE: Fluent Inflation Device 
VASCULAR SOLUTIONS, INC.          510(k) NO: K152387(Traditional)
ATTN: BEKA  VITE                  PHONE NO : 763 6464300 
6464 SYCAMORE COURT NORTH         SE DECISION MADE: 18-DEC-15
MINNEAPOLIS MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit
THE BINDING SITE GROUP LTD        510(k) NO: K152389(Traditional)
ATTN: STEPHANIE  THOULESS         PHONE NO : 44 0121 4569772 
8 CALTHORPE RD EDGBASTON          SE DECISION MADE: 18-DEC-15
BIRMINGHAM  GB B15 1QT            510(k) STATEMENT
                                                    
 
DEVICE: Stingray LP Catheter
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K152401(Traditional)
ATTN: KURTIS  HUNSBERGER          PHONE NO : 763 4941204 
ONE SCIMED PLACE                  SE DECISION MADE: 04-DEC-15
MAPLE GROVE MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SalivaMAX
FORWARD SCIENCE LLC               510(k) NO: K152406(Traditional)
ATTN: Brian  Pikkula              PHONE NO : 855 6967254 
3944 Bluebonnet Dr.               SE DECISION MADE: 23-DEC-15
Stafford TX  77477                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Adler MicroMed Laser Surgery Fibers 
ADLER MICROMED INC.               510(k) NO: K152417(Traditional)
ATTN: BRIAN  CHANDLER             PHONE NO : 484 9957919 
6842 ELAINE WAY                   SE DECISION MADE: 01-DEC-15
SAN DIEGO CA  92120               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Suntanning Lamps
Interlectric Corporation          510(k) NO: K152436(Traditional)
ATTN: Ken C. Frazier              PHONE NO : 814 7236061 
1401 Lexington Ave.               SE DECISION MADE: 07-DEC-15
Warren PA  16365                  510(k) STATEMENT
                                                    
 
DEVICE: KIRO Set
KIRO ROBOTICS S.L.                510(k) NO: K152441(Traditional)
ATTN: Naiara  Telleria            PHONE NO : 34 943 252249 
POLO DE INNOVACION GARAIA GOIRU KASE DECISION MADE: 04-DEC-15
ARRASATE-MONDRAGON  ES 20500      510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Freestyle Freedom Blood Glucose Monitoring Sytem
ABBOTT LABORATORIES               510(k) NO: K152442(Special)
ATTN: Sai Sriharshada Tatavarty   PHONE NO : 510 7495105 
1360 South Loop Road              SE DECISION MADE: 17-DEC-15
Alameda CA  94502                 510(k) STATEMENT
                                                    
 
DEVICE: VINTAGE Art LF
SHOFU DENTAL CORPORATION          510(k) NO: K152451(Traditional)
ATTN: MAURO  MALZYNER             PHONE NO : 760 7363277 
1225 STONE DRIVE                  SE DECISION MADE: 11-DEC-15
SAN MARCOS CA  92078              510(k) STATEMENT
                                                    
 
DEVICE: Rectangular Corpectomy Cage
Amendia, Inc.                     510(k) NO: K152460(Traditional)
ATTN: Bruce  Hooper               PHONE NO : 877 7553329 
1755 West Oak Parkway             SE DECISION MADE: 22-DEC-15
Marietta GA  30062                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Touch Ultrasound
CARESTREAM HEALTH, INC.           510(k) NO: K152467(Abbreviated)
ATTN: CAROLYN L. WAGNER           PHONE NO : 585 6276588 
150 VERONA STREET                 SE DECISION MADE: 09-DEC-15
ROCHESTER NY  14608               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FastFrame External Fixation System - Distal Radius
ZIMMER, INC.                      510(k) NO: K152484(Traditional)
ATTN: DOROTHY   SNYDER            PHONE NO : 574 3724092 
345 EAST MAIN STREET              SE DECISION MADE: 04-DEC-15
WARSAW IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MoMe Software Platform
INFOBIONIC, INC.                  510(k) NO: K152491(Traditional)
ATTN: MATTHEW  KING               PHONE NO : 978 6748304 
600 SUFFOLK STREET                SE DECISION MADE: 17-DEC-15
LOWELL MA  01854                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Ageless Health Medical Digital Thermometer
DONGGUAN AGELESS HEALTH INDUSTRIAL510(k) NO: K152508(Traditional)
ATTN: VICTOR  WAN                 PHONE NO : 86 769 81158038 
3/F, A1 BLDG, DONGSHEN SIMA INDUSTSE DECISION MADE: 31-DEC-15
DONGGUAN  CN 523560               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: 8X-10-XXXX Camera System
Santa Barbara Imaging Systems     510(k) NO: K152513(Traditional)
ATTN: James  Candy                PHONE NO : 805 7702110 
340 Storke Road, Suite 101        SE DECISION MADE: 15-DEC-15
Goleta CA  93117                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: TOMCAT Cervical Spinal System
CHOICE SPINE, LP                  510(k) NO: K152515(Traditional)
ATTN: Kim  Finch                  PHONE NO : 865 2463333 
400 Erin Drive                    SE DECISION MADE: 18-DEC-15
KNOXVILLE TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Attachable Cath Lab Hemostasis Valve
GALT MEDICAL CORP.                510(k) NO: K152528(Traditional)
ATTN: DAVID  DERRICK              PHONE NO : 972 2715177 
2220 MERRITT DR.                  SE DECISION MADE: 02-DEC-15
GARLAND TX  75041                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AERO -C Cervical Cage System
STRYKER SPINE                     510(k) NO: K152532(Traditional)
ATTN: SORAYA   KING               PHONE NO : 201 7498296 
2 PEARL COURT                     SE DECISION MADE: 18-DEC-15
ALLENDALE NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs
RIVERSTONE RESOURCES SDN BHD      510(k) NO: K152542(Traditional)
ATTN: SURESH  KUMAR               PHONE NO : 603 60283033 
LOT 55 & 56, NO13, JALAN JASMIN 2,SE DECISION MADE: 24-DEC-15
BUKIT BERUNTUNG  MY 48300         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AXI+LINE Proximal Bunion Correction System 
NEXTREMITY SOLUTIONS, Inc.        510(k) NO: K152548(Traditional)
ATTN: Ryan  Schlotterback         PHONE NO : 574 4852867 
210 North Buffalo Street          SE DECISION MADE: 21-DEC-15
Warsaw IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology
C.R. Bard, Inc.                   510(k) NO: K152554(Traditional)
ATTN: Kerrie  Hamblin             PHONE NO : 801 5224909 
605 North 5600 West               SE DECISION MADE: 14-DEC-15
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor,  HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors
SMITH & NEPHEW, INC.              510(k) NO: K152566(Traditional)
ATTN: KATHERINE  MARCACCIO        PHONE NO : 508 2613602 
130 FORBES BOULEVARD              SE DECISION MADE: 02-DEC-15
MANSFIELD MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
VOLCANO CORPORATION               510(k) NO: K152582(Special)
ATTN: NATHAN   DA SILVA           PHONE NO : 858 7641232 
3721 VALLEY CENTRE DR STE 500     SE DECISION MADE: 03-DEC-15
SAN DIEGO CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Beacon Fine Needle Fiducial System
Covidien LLC                      510(k) NO: K152586(Traditional)
ATTN: RACHEL  SILVA               PHONE NO : 408 3287359 
15 HAMPSHIRE STREET               SE DECISION MADE: 30-DEC-15
MANSFIELD MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GORE SYNECOR Biomaterial
W.L GORE & ASSOCIATES, INC.       510(k) NO: K152609(Traditional)
ATTN: BARBARA L. SMITH            PHONE NO : 410 5068189 
301 AIRPORT ROAD                  SE DECISION MADE: 11-DEC-15
ELKTON MD  21921                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: XSTAT 30, 3-PACK, XSTAT 30, 1-PACK
REVMEDX, INC.                     510(k) NO: K152624(Traditional)
ATTN: AMY K. POINTER              PHONE NO : 503 2182172 
25999 SW CANYON CREEK ROAD, SUITE SE DECISION MADE: 07-DEC-15
WILSONVILLE OR  97070             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory
STRYKER CORPORATION               510(k) NO: K152632(Traditional)
ATTN: SORAYA  KING                PHONE NO : 201 7498296 
2 PEARL COURT                     SE DECISION MADE: 02-DEC-15
ALLENDALE NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Laser Dock
PATIENT POCKET, LLC               510(k) NO: K152636(Traditional)
ATTN: ALLEN D SEFTEL              PHONE NO : 216 2720805 
405 HIALEAH DRIVE                 SE DECISION MADE: 17-DEC-15
CHERRY HILL NJ  08002             510(k) STATEMENT
                                                    
 
DEVICE: DR 600
AGFA HEALTHCARE N.V.              510(k) NO: K152639(Traditional)
ATTN: Koren  Vervoort             PHONE NO : 32 3444 7368 
SEPTESTRAAT 27                    SE DECISION MADE: 11-DEC-15
MORTSEL  BE B 2640                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100
KEELER LIMITED                    510(k) NO: K152644(Special)
ATTN: IRINA  PROUTSKI             PHONE NO : 44 017 53827153 
CLEWER HILL ROAD                  SE DECISION MADE: 31-DEC-15
WINDSOR  GB SL4 4AA               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AccuLIF TL and PL Cage
STRYKER CORPORATION               510(k) NO: K152651(Traditional)
ATTN: AAKASH   JAIN               PHONE NO : 201 7498074 
2 PEARL COURT                     SE DECISION MADE: 15-DEC-15
ALLENDALE NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Powder Free Vinyl Patient Examination Gloves (Green)
Supermax Plastic Products Co., Ltd510(k) NO: K152692(Traditional)
ATTN: Wu  Zhigang                 PHONE NO : 86 311 83601854 
314 Dragon River East Road        SE DECISION MADE: 21-DEC-15
Shijiazhuang City  CN 050000      510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Quanta Forte
QUANTA SYSTEM SPA                 510(k) NO: K152714(Traditional)
ATTN: FRANCESCO  DELL'ANTONIO     PHONE NO : 39 0331 376797 
VIA IV NOVEMBRE, 116              SE DECISION MADE: 21-DEC-15
SOLBIATE OLONA (VA)  IT 21058     510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Cytal Wound Matrix 
ACELL, INC                        510(k) NO: K152721(Special)
ATTN: THOMAS  GILBERT             PHONE NO : 410 9538509 
6640 ELI WHITNEY DR               SE DECISION MADE: 08-DEC-15
COLUMBIA MD  21046                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: neoV980 & neoV1470 Diode Lasers
G.N.S NEO LASER LTD.              510(k) NO: K152722(Traditional)
ATTN: GIL  SHAPIRA                PHONE NO : 97 246 779919 
7 HA'ESHEL STR                    SE DECISION MADE: 08-DEC-15
CAESAREA  IL 38900                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AOS Small Fragment Plating System
AVANCED ORTHOPAEDIC SOLUTIONS, INC510(k) NO: K152732(Traditional)
ATTN: Mark  Steinhauer            PHONE NO : 310 5339966 
3203 KASHIWA STREET               SE DECISION MADE: 10-DEC-15
TORRANCE CA  90505                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FastFrame External Fixation System-Ankle Spanning
Zimmer, Inc.                      510(k) NO: K152755(Traditional)
ATTN: Dorothy  Snyder             PHONE NO : 574 3724092 
345 East Main Street              SE DECISION MADE: 21-DEC-15
Warsaw IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OTC12D AUTO RADIOGRAPHIC SYSTEM
DEL MEDICAL, INC.                 510(k) NO: K152767(Abbreviated)
ATTN: JOHN  HARTZELL              PHONE NO : 847 2887021 
241 COVINGTON DR.                 SE DECISION MADE: 14-DEC-15
BLOOMINGDALE IL  60108            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL
THERMO FISHER SCIENTIFIC          510(k) NO: K152774(Traditional)
ATTN: CYNTHIA  KNAPP              PHONE NO : 800 8718909 322
1 THERMO FISHER WAY               SE DECISION MADE: 21-DEC-15
OAKWOOD VILLAGE OH  440146        510(k) STATEMENT
                                                    
 
DEVICE: SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT
WILLIAM A. COOK AUSTRALIA PTY LTD 510(k) NO: K152782(Special)
ATTN: GORDANA  POZVEK             PHONE NO : 61 738 411188 
95 BRANDL STREET                  SE DECISION MADE: 21-DEC-15
EIGHT MILE PLAINS  AU 4113        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Merit 20 mL Syringe
Merit Medical Systems, Inc.       510(k) NO: K152783(Special)
ATTN: CORY  MARSH                 PHONE NO : 801 3163690 
1600 W Merit Parkway              SE DECISION MADE: 07-DEC-15
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Giraffe Incubator Carestation CS1
OHMEDA MEDICAL, A DIVISION OF DATE510(k) NO: K152809(Special)
ATTN: KENNY  BELLO                PHONE NO : 410 8885393 
8880 GORMAN ROAD                  SE DECISION MADE: 31-DEC-15
LAUREL MD  20723                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Lantern Delivery Microcatheter 
PENUMBRA, INC.                    510(k) NO: K152840(Special)
ATTN: CHARLES  DENAULT            PHONE NO : 510 7483302 
ONE PENUMBRA PLACE                SE DECISION MADE: 02-DEC-15
ALAMEDA CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BrainPort V100
WICAB, INC.                       510(k) NO: K152851(Traditional)
ATTN: ROBERT  BECKMAN             PHONE NO : 608 8294500 
8313 GREENWAY BLVD. SUITE 100     SE DECISION MADE: 24-DEC-15
DANE WI  53562                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
BAYER HEALTHCARE, LLC             510(k) NO: K152852(Traditional)
ATTN: William R Walsh             PHONE NO : 973 8866355 
100 BAYER BOULEVARD               SE DECISION MADE: 22-DEC-15
WHIPPANY NJ  07981-0915           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps
NEOMED, INC.                      510(k) NO: K152857(Traditional)
ATTN: TONY  LAIR                  PHONE NO : 888 8762225 
100 LONDONDERRY CT. SUITE 112     SE DECISION MADE: 17-DEC-15
WOODSTOCK GA  30188               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Portable X-ray System (Model:  MINIX-V / MINIX-S)
DIGIMED CO., LTD. (DIGIMED CORPORA510(k) NO: K152859(Traditional)
ATTN: YOUNGBAE  KWON              PHONE NO : 82 226 241551 
309-311, 318-HO, 145, GRASAN DIGITSE DECISION MADE: 03-DEC-15
SEOUL  KR 153-787                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL
CONMED CORPORATION                510(k) NO: K152860(Traditional)
ATTN: LISA  ANDERSON              PHONE NO : 315 6243371 
525 FRENCH ROAD                   SE DECISION MADE: 29-DEC-15
UTICA NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls
INOVA DIAGNOSTICS, INC.           510(k) NO: K152875(Traditional)
ATTN: GABRIELLA  LAKOS            PHONE NO : 858 5869900 1393
9900 OLD GROVE ROAD               SE DECISION MADE: 21-DEC-15
SAN DIEGO CA  92131-1638          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS
BIORENEW LABS, LLC                510(k) NO: K152889(Traditional)
ATTN: JON  DAVID                  PHONE NO : 310 9978691 
4154 PIER AVENUE                  SE DECISION MADE: 30-DEC-15
HERMOSA BEACH CA  90254           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SYDNEY IVF EMBRYO BIOPSY MEDIUM
WILLIAM A. COOK AUSTRALIA PTY, LTD510(k) NO: K152904(Special)
ATTN: GORDANA  POZVEK             PHONE NO : 61 738 411188 
95 BRANDL STREET                  SE DECISION MADE: 03-DEC-15
EIGHT MILE PLAINS  AU 4113        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NuVasive Foundation-LL System
NUVASIVE INCORPORATED             510(k) NO: K152943(Traditional)
ATTN: CYNTHIA  ADAMS              PHONE NO : 858 3204549 
7475 LUSK BOULEVARD               SE DECISION MADE: 01-DEC-15
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Alevicyn SG Antipruritic Gel
OCULUS INNOVATIVE SCIENCES        510(k) NO: K152945(Traditional)
ATTN: BRIAN W. MARTIN             PHONE NO : 707 2830550 
1129 N. MCDOWELL BOULEVARD        SE DECISION MADE: 15-DEC-15
PETALUMA CA  94954                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray
PARAGON MEDICAL, INC.             510(k) NO: K152951(Third Party - Traditional)
ATTN: MIKE  GOSMEYER              PHONE NO : 574 5942140 10381
8 MATCHETT INDUSTRIAL PARK DRIVE  SE DECISION MADE: 28-DEC-15
PIERCETON IN  46562               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: INEX Absorbable Nasal Implant
SPIROX, INC.                      510(k) NO: K152958(Traditional)
ATTN: MIKE  ROSENTHAL             PHONE NO : 650 5033329 
3475-O EDISON WAY                 SE DECISION MADE: 04-DEC-15
MENLO PARK CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Arsenal Spinal Fixation System
ALPHATEC SPINE, INC               510(k) NO: K152968(Traditional)
ATTN: RENEE  MURPHY               PHONE NO : 760 4946739 
5818 EL CAMINO REAL               SE DECISION MADE: 30-DEC-15
CARLSBAD CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ORTHOLOC® 3Di Foot Plating Reconstruction System
Wright Medical Technology, Inc.   510(k) NO: K152974(Traditional)
ATTN: Val  Myles                  PHONE NO : 901 2905162 
1023 Cherry Road                  SE DECISION MADE: 11-DEC-15
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System
XENCO MEDICAL, LLC                510(k) NO: K152987(Special)
ATTN: GUSTAVO  PRADO              PHONE NO : 858 2021505 
9930 MESA RIM ROAD                SE DECISION MADE: 11-DEC-15
SAN DIEGO CA  92121               510(k) STATEMENT
                                                    
 
DEVICE: Molteno3 Glaucoma Implant 
INNOVATIVE OPHTHALMIC PRODUCTS, IN510(k) NO: K152996(Traditional)
ATTN: BRYAN  WEINMANN             PHONE NO : 714 5491185 
3184-B AIRWAY AVE                 SE DECISION MADE: 17-DEC-15
COSTA MESA CA  92626              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE:  iViewDose R1.0
Elekta Limited                    510(k) NO: K153011(Traditional)
ATTN: Maurice  Paine              PHONE NO : 0044 1293 654284 
Linac House Fleming Way           SE DECISION MADE: 11-DEC-15
Crawley  GB rh10 9rr              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Traxcess Pro 14 Guidewire
MICROVENTION, INC.                510(k) NO: K153053(Special)
ATTN: SAPNA  SINGH                PHONE NO : 714 2478162 
1311 VALENCIA AVENUE              SE DECISION MADE: 29-DEC-15
TUSTIN CA  72780                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Solitaire Platinum Revascularization Device
Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K153071(Special)
ATTN: Phuong  Chau                PHONE NO : 949 2975487 
9775 Toledo Way                   SE DECISION MADE: 23-DEC-15
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Q Series Diagnostic Ultrasound System
CHISON MEDICAL IMAGING CO., LTD.  510(k) NO: K153085(Traditional)
ATTN: Qifei  Liu                  PHONE NO : 86 510 85311707 
NO.228, CHANGJIANG EAST ROAD, BLOCSE DECISION MADE: 21-DEC-15
WUXI  CN 214142                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K153088(Traditional)
ATTN: ASHLEY  SANTOS              PHONE NO : 508 6834359 
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 11-DEC-15
MARLBOROUGH MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Ally Uterine Positioning System
CooperSurgical, Inc.              510(k) NO: K153092(Special)
ATTN: Roaida  Johnson             PHONE NO : 203 6015200 
95 Corporate Drive                SE DECISION MADE: 21-DEC-15
Trumbull CT  06611                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Visions PV .035 Digital IVUS Catheter
Volcano Corporation               510(k) NO: K153094(Special)
ATTN: Neeta  Sharma               PHONE NO : 858 7204187 
3721 Valley Centre Dr Ste 500     SE DECISION MADE: 31-DEC-15
San Diego CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Endoskeleton(r) TCS System
TITAN SPINE, LLC                  510(k) NO: K153122(Traditional)
ATTN: Jane  Rodd                  PHONE NO : 262 2427801 
6140 W. EXECUTIVE DRIVE, SUITE A  SE DECISION MADE: 14-DEC-15
MEQUON WI  53092                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: da Vinci Xi Hasson Cone
INTUITIVE SURGICAL INC.           510(k) NO: K153126(Traditional)
ATTN: VISHAL  KANANI              PHONE NO : 408 5238907 
1266 KIFER ROAD                   SE DECISION MADE: 09-DEC-15
SUNNYVALE CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating  
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K153140(Special)
ATTN: JOSHUA P. EWING             PHONE NO : 1 800 2623304 7473
125 BLUE BALL ROAD                SE DECISION MADE: 02-DEC-15
ELKTON MD  21921                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Capiox Advance Hardshell Reservoir
Terumo Cardiovascular Systems Corp510(k) NO: K153143(Special)
ATTN: Tierra A. Brown             PHONE NO : 800 2623304 7021
125 Blue Ball Road                SE DECISION MADE: 02-DEC-15
Elkton MD  21921                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping
CENTERS FOR DISEASE CONTROL AND PR510(k) NO: K153148(Special)
ATTN: YON  YU                     PHONE NO : 404 6393046 
1600 CLIFTON ROAD, MS-C18         SE DECISION MADE: 01-DEC-15
ATLANTA GA  30329-4027            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Asnis JFX System
Stryker Trauma AG                 510(k) NO: K153154(Traditional)
ATTN: Garry T. Hayeck             PHONE NO : 201 8316802 
325 Corporate Drive               SE DECISION MADE: 28-DEC-15
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Solution Administration Sets with 0.2 Micron Filter
BAXTER HEALTHCARE CORPORATION     510(k) NO: K153158(Special)
ATTN: GARY  CHUMBIMUNE            PHONE NO : 224 2703312 
32650 N WILSON ROAD               SE DECISION MADE: 28-DEC-15
ROUND LAKE IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Beacon Tissue Marker (SE)
SCION MEDICAL TECHNOLOGIES, LLC   510(k) NO: K153189(Special)
ATTN: LOUIS  LI                   PHONE NO : 888 5826211 
4613 WEST CHESTER PIKE            SE DECISION MADE: 17-DEC-15
NEWTOWN SQUARE PA  19073          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Internal Joint Stabilizer - Elbow
SKELETAL DYNAMICS, LLC            510(k) NO: K153208(Traditional)
ATTN: Ana M Escagedo              PHONE NO : 305 5967585 
8905 SW 87 AVENUE, SUITE 201      SE DECISION MADE: 31-DEC-15
MIAMI FL  33176                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Defibrillator Analyzer Variable Load
BC GROUP INTERNATIONAL, INC       510(k) NO: K153210(Traditional)
ATTN: Mel  Roche                  PHONE NO : 314 6383800 
3081 ELM POINT INDUSTRIAL DRIVE   SE DECISION MADE: 21-DEC-15
SAINT CHARLES MO  63301           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir
Terumo Cardiovascular Systems Corp510(k) NO: K153213(Special)
ATTN: Tierra A Brown              PHONE NO : 800 2623304 7021
125 Blue Ball Road                SE DECISION MADE: 03-DEC-15
Elkton MD  21921                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ProParaFlu+ Assay
HOLOGIC, INC.                     510(k) NO: K153223(Special)
ATTN: RON  DOMINGO                PHONE NO : 858 4108167 
10210 GENETIC CENTER DRIVE        SE DECISION MADE: 09-DEC-15
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NMI Port, NMI Port II
NAVILYST MEDICAL, INC.            510(k) NO: K153228(Special)
ATTN: Robin  Fuller               PHONE NO : 508 6587986 
26 FOREST STREET                  SE DECISION MADE: 04-DEC-15
MARLBOROUGH MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BD FlowSmart Set, MiniMed Pro-Set
BECTON, DICKINSON AND COMPANY     510(k) NO: K153257(Special)
ATTN: MATTHEW  TRACHTENBERG       PHONE NO : 201 8476337 
1 BECTON DRIVE                    SE DECISION MADE: 11-DEC-15
FRANKLIN LAKES NJ  07666          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AccuCath Intravascular Catheter
C.R. Bard, Inc.                   510(k) NO: K153298(Special)
ATTN: Casey  Coombs               PHONE NO : 801 5225869 
605 North 5600 West               SE DECISION MADE: 10-DEC-15
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Imbibe Needle
ORTHOVITA, INC.                   510(k) NO: K153306(Special)
ATTN: LYNN  LUNDY                 PHONE NO : 610 4075256 
45 GREAT VALLEY PARKWAY           SE DECISION MADE: 18-DEC-15
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Klassic Knee System
TOTAL JOINT ORTHOPEDICS, INC.     510(k) NO: K153310(Special)
ATTN: CHRIS  WEABER               PHONE NO : 801 4866070 
1567 E. STRATFORD AVENUE          SE DECISION MADE: 17-DEC-15
SALT LAKE CITY UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SpeedLock Knotless Fixation System
ARTHROCARE CORPORATION            510(k) NO: K153313(Special)
ATTN: LAURA  KASPEROWICZ          PHONE NO : 949 5852406 
15285 ALTON PARWAY, SUITE 200     SE DECISION MADE: 11-DEC-15
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Philips Eleva Workspot with SkyFlow
Philips Medical Systems DMC GmbH  510(k) NO: K153318(Special)
ATTN: MING  XIAO                  PHONE NO : 49 405 0782306 
Roentgenstrasse 24-26             SE DECISION MADE: 22-DEC-15
Hamburg  DE 22335                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Asahi REXEED-S Series Dialyzer
Asahi Kasei Medical Co., Ltd.     510(k) NO: K153344(Special)
ATTN: Hidenobu  Nakazawa          PHONE NO : 81 3 32963773 
1-105 Kanda Jinbocho              SE DECISION MADE: 17-DEC-15
Chiyoda-ku  JP 101-8101           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AquaShield system CO2, AquaShield system-PENTAX
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K153362(Special)
ATTN: CARROLL  MARTIN             PHONE NO : 440 3586259 
5976 HEISLEY ROAD                 SE DECISION MADE: 16-DEC-15
MENTOR OH  44060                  510(k) STATEMENT
                                                    
 
DEVICE: ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K153365(Traditional)
ATTN: KIRA  GORDON                PHONE NO : 914 5242996 
511 BENEDICT AVENUE               SE DECISION MADE: 18-DEC-15
TARRYTOWN NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz
VOLCANO CORPORATION               510(k) NO: K153369(Special)
ATTN: Brian   Park                PHONE NO : 858 7204176 
3721 Valley Centre Dr Ste 500     SE DECISION MADE: 22-DEC-15
San Diego CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Advanced Perfusion System 1
Terumo Cardiovascular Systems Corp510(k) NO: K153376(Special)
ATTN: Bryan  Hann                 PHONE NO : 734 7415816 
6200 Jackson Road                 SE DECISION MADE: 16-DEC-15
Ann Arbor MI  48103               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Monster BITE Screw System
PARAGON 28                        510(k) NO: K153378(Special)
ATTN: Frank S. Bono               PHONE NO : 888 7281888 
4B INVERNESS CT. E STE 280        SE DECISION MADE: 21-DEC-15
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GR40CW
SAMSUNG ELECTRONICS CO., LTD.     510(k) NO: K153401(Traditional)
ATTN: CHULSIN  KIM                PHONE NO : 82 312 007661 
129, SAMSUNG-RO YEONGTONG-GU      SE DECISION MADE: 21-DEC-15
SUWON-SI  KR 443-742              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: HM70A Diagnostic Ultrasound System
SAMSUNG MEDISON CO., LTD          510(k) NO: K153408(Third Party - Traditional)
ATTN: Jiyoung   Kim               PHONE NO : 82 2 21941299 
42, TEHERAN-RO 108-GIL GANGNAM-GU SE DECISION MADE: 21-DEC-15
SEOUL  KR 135-851                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: ST AIA-PACK PROG III Calibrator Set
TOSOH BIOSCIENCE, INC.            510(k) NO: K153417(Traditional)
ATTN: ROBERT L. WICK              PHONE NO : 650 6368117 
6000 SHORELINE COURT SUITE 101    SE DECISION MADE: 18-DEC-15
SOUTH SAN FRANCISCO CA  94080     510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Apex Revision Knee System
OMNILIFE SCIENCE                  510(k) NO: K153437(Special)
ATTN: CHRISTINA  ROVALDI          PHONE NO : 774 2261857 
50 O'CONNELL WAY SUITE 10         SE DECISION MADE: 21-DEC-15
EAST TAUNTON MA  02718            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Microlife Upper Arm Automatic Digital Blood Pressure Monitor
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K153450(Special)
ATTN: GERHARD  FRICK              PHONE NO : 41 717 277059 
ESPENSTRASSE 139                  SE DECISION MADE: 16-DEC-15
 WIDNAU  CH 9443                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm
MAQUET CRITICAL CARE AB           510(k) NO: K153461(Special)
ATTN: Mirva   Boothe              PHONE NO : 46 10 3357300 
RONTGENVAGEN 2                    SE DECISION MADE: 11-DEC-15
SOLNA  SE SE-171 54               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CD HORIZON Spinal System, IPC POWEREASE System
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K153463(Special)
ATTN: Becky   Ronner              PHONE NO : 901 3963133 
1800 PYRAMID PLACE                SE DECISION MADE: 30-DEC-15
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ClearVue850 Diagnostic Ultrasound System
PHILIPS HEALTHCARE                510(k) NO: K153480(Third Party - Traditional)
ATTN: Saraswathi   Deora          PHONE NO : 91 804 1892714 
22100 BOTHELL EVERETT HIGHWAY     SE DECISION MADE: 16-DEC-15
BOTHELL WA  98021-8431            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: Balloon controller PB-30
FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K153483(Special)
ATTN: Aaron   Ge                  PHONE NO : 973 6862636 
10 HIGH POINT DR                  SE DECISION MADE: 15-DEC-15
WAYNE NJ  07470                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CareView 1800L
CARERAY DIGITAL MEDICAL SYSTEM CO.510(k) NO: K153492(Special)
ATTN: Leilei   Li                 PHONE NO : 86 512 86860288 
A2-201/B3-501, BIOBAY, 218 XINGHU SE DECISION MADE: 24-DEC-15
SUZHOU  CN 215123                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension 
ConMed Corporation                510(k) NO: K153499(Special)
ATTN: Dionne   Sanders            PHONE NO : 727 3995564 
525 French Road                   SE DECISION MADE: 18-DEC-15
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
 
             TOTAL 510(k)s THIS PERIOD   254                                     
             TOTAL WITH SUMMARIES        239                                     
             TOTAL WITH STATEMENTS        15
                                      

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