Medical Devices

November 2015 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD November 2015


DEVICE: LUXATOR LX HANDPIECE
DIRECTA AB                        510(k) NO: K133178(Traditional)
ATTN: HENRIC  KARSK               PHONE NO : 46 8 50650575 
P.O. BOX 723                      SE DECISION MADE: 24-NOV-15
UPPLANDS VASBY  SE SE-194 47      510(k) STATEMENT
                                                    

DEVICE: OT EQUATOR
Rhein '83 SRL                     510(k) NO: K142211(Traditional)
ATTN: Claudia  Nardi              PHONE NO : 39 051 244510 
Via Emilio Zago, 10/abc           SE DECISION MADE: 25-NOV-15
Bologna  IT 40128                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ArcCHECK
SUN NUCLEAR CORPORATION           510(k) NO: K142617(Traditional)
ATTN: Noel  Downey                PHONE NO : 321 2596862 242
3275 Suntree Blvd.                SE DECISION MADE: 20-NOV-15
Melbourne FL  32940               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color. 
PT MEDISAFE TECHNOLOGIES          510(k) NO: K142941(Traditional)
ATTN: Anil  Taneja                PHONE NO : 62 61 30007134 
JI BATANG KUIS, GG TAMBAK REJO PASSE DECISION MADE: 02-NOV-15
TANJUNG MORAWA, MEDAN  ID 20362   510(k) STATEMENT
                                                    

DEVICE: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K142955(Traditional)
ATTN: Kimberly  Mangum            PHONE NO : 610 4484912 
51 VALLEY STREAM PKWY.            SE DECISION MADE: 24-NOV-15
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JDENTALCARE Implant System
J DENTAL CARE S.r.l               510(k) NO: K143142(Traditional)
ATTN: Giacomo  Grandi             PHONE NO : 39 059 454255 
Via del Tirassegno 41/N           SE DECISION MADE: 06-NOV-15
MODENA  IT 41122                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MoisturemeterD
DELFIN TECHNOLOGIES LTD.          510(k) NO: K143310(Traditional)
ATTN: Theodore  Sullivan          PHONE NO : 1 202 4527992 
MICROKATU 1                       SE DECISION MADE: 19-NOV-15
KUDPIO  FI 70210                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Safety Auto-Disable Syrine with Needle (Auto-Lock)
GUANGDONG INTMED MEDICAL APPLIANCE510(k) NO: K143497(Traditional)
ATTN: HU  YIHAN                   PHONE NO : 86 75 72223660 
1# SOUTH ROAD EUROPE INDUSTRY PARKSE DECISION MADE: 04-NOV-15
FOSHAN  CN 528300                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PGA RESORBA, PGA RESOQUICK, GLYCOLON
RESORBA MEDICAL GMBH              510(k) NO: K143584(Traditional)
ATTN: KARL JOSEF BECK             PHONE NO : 49 9128 91150 
AM FLACHMOOOR 16                  SE DECISION MADE: 02-NOV-15
NUREMBERG  DE 90475               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Invisalign System
ALIGN TECHNOLOGY, INC.            510(k) NO: K143630(Traditional)
ATTN: Margaret  Anderson          PHONE NO : 1 408 4701410 
2560 Orchard Parkway              SE DECISION MADE: 18-NOV-15
San Jose CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter
MEDGYN PRODUCTS, INC.             510(k) NO: K143669(Traditional)
ATTN: AMAR  AGADI                 PHONE NO : 1 630 9257446 
100 W. Industrial Rd.             SE DECISION MADE: 23-NOV-15
Addison IL  60101                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEDLINE SHARPS CONTAINERS
MEDLINE INDUSTRIES, INC.          510(k) NO: K143693(Traditional)
ATTN: Matt  Clausen               PHONE NO : 847 6434785 
ONE MEDLINE PLACE                 SE DECISION MADE: 06-NOV-15
MUNDLELEIN IL  60060              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advanced Air System
W & H Dentalwerk Buermoos GmbH    510(k) NO: K143704(Traditional)
ATTN: Anja  Lindner               PHONE NO : 0043 6274 6236397 
Ignaz-Glaser-Strasse 53           SE DECISION MADE: 23-NOV-15
Buermoos  AT 5111                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing
KCI USA, INC.                     510(k) NO: K150006(Traditional)
ATTN: MELANIE  AVILA              PHONE NO : 210 5154059 
6203 FARINON DRIVE                SE DECISION MADE: 06-NOV-15
SAN ANTONIO TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SonicLift
PRETIKA CORPORATION               510(k) NO: K150077(Traditional)
ATTN: Thomas  Nichols             PHONE NO : 1 949 4818818 
12215 Holly Street                SE DECISION MADE: 25-NOV-15
Riverside CA  92509               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla
Good Clean Love, Inc.             510(k) NO: K150094(Traditional)
ATTN: Wendy  Strgar               PHONE NO : 541 3444483 
207 West 5th Avenue               SE DECISION MADE: 19-NOV-15
Eugene OR  97401                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SnoreSounds 
APPIAN MEDICAL, INC.              510(k) NO: K150102(Traditional)
ATTN: MICHAEL J THOMAS            PHONE NO : 415 7775251 
502 SCRIMSHAW WAY                 SE DECISION MADE: 05-NOV-15
SEVEMA PARK MD  21146             510(k) STATEMENT
                                                    

DEVICE: Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K150168(Traditional)
ATTN: Anna Marie  Kathleen Ennis  PHONE NO : 1 302 6319352 
500 GBC DRIVE                     SE DECISION MADE: 04-NOV-15
NEWARK DE  19714                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EzFuze Implant System
VILEX IN TENNESSEE, INC.          510(k) NO: K150211(Traditional)
ATTN: SYLVIA  SOUTHARD            PHONE NO : 931 4747550 
111 MOFFITT STREET                SE DECISION MADE: 10-NOV-15
MCMINNVILLE TN  37110             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Equashield Closed System drug Transfer Device (CSTD)
EQUASHIELD MEDICAL LTD            510(k) NO: K150219(Traditional)
ATTN: Raymond J Kelly             PHONE NO : 
TEFEN INDUSTRIAL PARK P.O. B 12   SE DECISION MADE: 05-NOV-15
MIGDAL  IL 24959                  510(k) STATEMENT
                                                    

DEVICE: SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color
MEDLINE INDUSTRIES, INC.          510(k) NO: K150238(Traditional)
ATTN: CLAIRE  WELLINGHOFF         PHONE NO : 1 847 6434071 
ONE MEDLINE PLACE                 SE DECISION MADE: 27-NOV-15
MUNDLELEIN IL  60060              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L
TAIWAN SURGICAL CORPORATION       510(k) NO: K150259(Traditional)
ATTN: Hsiu-Ping  Huang            PHONE NO : 886 365 88129 
3F., No. 12. Sec 2, ShengYi Rd.   SE DECISION MADE: 06-NOV-15
Zhubei City  TW 30261             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CerOX
OR-NIM MEDICAL LTD.               510(k) NO: K150268(Traditional)
ATTN: MICHA  OESTEREICH           PHONE NO : 972 8 9282801 
15 ATIR YEDA ST.                  SE DECISION MADE: 06-NOV-15
KFAR SABA  IL 4464312             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Entropy Module, E-ENTROPY-01
GE HEALTHCARE FILAND OY           510(k) NO: K150298(Traditional)
ATTN: JOEL  KENT                  PHONE NO : 358 10 39411 
KUORTANEENKATU 2                  SE DECISION MADE: 12-NOV-15
HELSINKI  FI 00510                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gmate SMART Blood Glucose Monitoring System
Philosys Inc.                     510(k) NO: K150299(Traditional)
ATTN: Linda  Chan                 PHONE NO : 646 4545414 
304 Park Avenue South, Suite 218  SE DECISION MADE: 19-NOV-15
New York NY  10010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: elance Vital Signs Monitor, Central Monitor Software
SPACELABS HEALTHCARE              510(k) NO: K150329(Traditional)
ATTN: Al Van Houdt                PHONE NO : 425 3635970 
35301 SE CENTER STREET            SE DECISION MADE: 05-NOV-15
SNOQUALMIE WA  98065              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BTL-4000
BTL INDUSTRIES, INC               510(k) NO: K150353(Traditional)
ATTN: Jan  Zarsky                 PHONE NO : 866 2851656 
47 Loring Drive                   SE DECISION MADE: 13-NOV-15
Framingham MA  01702              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
GOLD STANDARD DIAGNOSTICS         510(k) NO: K150358(Traditional)
ATTN: NAPOLEON  MONCE             PHONE NO : 530 7598000 
2851 SPAFFORD                     SE DECISION MADE: 12-NOV-15
DAVIS CA  95618                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyece OTC TENS Device
TYECE LTD                         510(k) NO: K150386(Traditional)
ATTN: Parshid  Falahati           PHONE NO : 852 2 3497456 
Unit 801, Block A, Po Lung Centre,SE DECISION MADE: 05-NOV-15
 Kowloon, Hong Kong  HK           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental Implant System
BIO CONCEPT CO., LTD              510(k) NO: K150388(Traditional)
ATTN: HUA  CAO                    PHONE NO : 86 519 85172266 
UNIT C, NO. 26, HUASHAN MIDDLE ROASE DECISION MADE: 12-NOV-15
CHANGZHOU  CN 213022              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Divine 9
CarraShield Labs, Inc.            510(k) NO: K150397(Traditional)
ATTN: Dean  Fresonke              PHONE NO : 407 9562186 
8815 Conroy Road                  SE DECISION MADE: 09-NOV-15
Orlando FL  32835                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ComboRehab
SHENZHEN DONGDIXIN TECHNOLOGY CO, 510(k) NO: K150436(Traditional)
ATTN: Jianping  Kang              PHONE NO : 086 075527 652471 
No. 3 Building XiliBaimang XushengSE DECISION MADE: 13-NOV-15
SHENZHEN  CN 518108               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RT2 Trabeculite Titanium Cervical Cage System
RHAUSLER, INC.                    510(k) NO: K150455(Abbreviated)
ATTN: TERRY  JOHNSTON             PHONE NO : 1 650 6314515 
837 INDUSTRIAL ROAD UNIT E        SE DECISION MADE: 19-NOV-15
SAN CARLOS CA  94070              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Humelock II Reversible Shoulder System
FX SOLUTIONS                      510(k) NO: K150488(Traditional)
ATTN: Jean-Jacques  Martin        PHONE NO : 33 474 553555 
1663 RUE DE MAJORNAS              SE DECISION MADE: 13-NOV-15
VIRIAT  FR 01440                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor
PCI MEDICAL, INC.                 510(k) NO: K150504(Traditional)
ATTN: Kevin  Mader                PHONE NO : 860 5262862 
6 WINTER AVE.                     SE DECISION MADE: 16-NOV-15
DEEP RIVER CT  06443              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters
C.R. Bard, Inc.                   510(k) NO: K150514(Traditional)
ATTN: James R. Davis              PHONE NO : 1 801 5225456 
                                  SE DECISION MADE: 20-NOV-15
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K150525(Traditional)
ATTN: SUSIE S. CHEN               PHONE NO : 1 424 2188201 
2151 E. GRAND AVE                 SE DECISION MADE: 20-NOV-15
EL SEGUNDO CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cortisol Saliva Luminescence Immunoassay
IBL INTERNATIONAL GMBH            510(k) NO: K150528(Traditional)
ATTN: NICOLA  KAISER              PHONE NO : 49 40 532891 482
FLUGHAFENSTRASSE 52 A             SE DECISION MADE: 25-NOV-15
HAMBURG  DE D-22335               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SilverCoat Silicone Foley Catheter
COVALON TECHNOLOGIES, INC.        510(k) NO: K150550(Traditional)
ATTN: Kim  Crooks                 PHONE NO : 905 5688400 265
405 BRITANNIA RD. EAST SUITE 106  SE DECISION MADE: 24-NOV-15
MISSISSAUGA  CA L4Z 3E6           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Eclipse System
Pelvalon, Inc.                    510(k) NO: K150558(Traditional)
ATTN: MILES  ROSEN                PHONE NO : 1 650 2760130 
923 Thompson Place                SE DECISION MADE: 12-NOV-15
Sunnyvale CA  94085               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System
Narang Medical Limited            510(k) NO: K150561(Traditional)
ATTN: Vivek  Narang               PHONE NO : 91 114555 4000 
46, Naraina Industriall Area, PhasSE DECISION MADE: 25-NOV-15
New Delhi  IN 110028              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3i T3 Short Implants
BIOMET3I                          510(k) NO: K150571(Traditional)
ATTN: CHRIS  MCKEE                PHONE NO : 561 7766700 
4555 RIVERSIDE DRIVE              SE DECISION MADE: 20-NOV-15
PALM BEACH GARDENS FL  33410      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube
Teleflex Medical, Inc.            510(k) NO: K150603(Traditional)
ATTN: Lori  Pfohl                 PHONE NO : 919 4918960 
2917 Weck Drive                   SE DECISION MADE: 27-NOV-15
Research Triangle Park NC  27709  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Annuy Latex Surgeon's Gloves (Powdered and Powder Free)
ANHUI ANYU LATEX PRODUCTS CO., LTD510(k) NO: K150609(Traditional)
ATTN: NONE  PROVIDED              PHONE NO : 
EAST QINJI ROAD & NORTH XINGHUA ROSE DECISION MADE: 16-NOV-15
BENGBU  CN 233010                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free)  
ANHUI ANYU LATEX PRODUCTS CO., LTD510(k) NO: K150612(Traditional)
ATTN: NONE   PROVIDED             PHONE NO : 
EAST QINJI ROAD & NORTH XINGHUA ROSE DECISION MADE: 16-NOV-15
BENGBU  CN 233010                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PENTAX Medical EPK-i7010 Video Processor with GI Family
PENTAX OF AMERICA, INC.           510(k) NO: K150618(Traditional)
ATTN: KRISHNA  GOVINDARAJAN       PHONE NO : 800 4315880 
3 PARAGON DRIVE                   SE DECISION MADE: 24-NOV-15
MONTVALE NJ  07645                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aerin Medical Wand Model FG011
Aerin Medical, Inc.               510(k) NO: K150637(Traditional)
ATTN: Scott  Wolf                 PHONE NO : 650 4343247 
690 W. Fremont Avenue Unit 3      SE DECISION MADE: 19-NOV-15
Sunnyvale CA  94087               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AN85/AN86 EO Indicators
ANDERSEN STERILIZERS, INC.        510(k) NO: K150644(Traditional)
ATTN: William K. Andersen         PHONE NO : 336 3768622 
3154 CAROLINE DRIVE               SE DECISION MADE: 18-NOV-15
HAW RIVER NC  27258               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AN1087 Dosimeter
ANDERSEN STERILIZERS, INC.        510(k) NO: K150645(Traditional)
ATTN: William K. Andersen         PHONE NO : 336 3768622 
3154 CAROLINE DRIVE               SE DECISION MADE: 19-NOV-15
HAW RIVER NC  27258               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EOGas 4 Ethylene Oxide Gas Sterilizer
ANDERSEN STERILIZERS, INC.        510(k) NO: K150646(Traditional)
ATTN: WILLIAM K. ANDERSEN         PHONE NO : 1 336 3768622 
3154 CAROLINE DRIVE               SE DECISION MADE: 18-NOV-15
HAW RIVER NC  27258               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WASTON General Spinal System
CHANGZHOU WASTON MEDICAL APPLIANCE510(k) NO: K150684(Traditional)
ATTN: Jack  Lu                    PHONE NO : 86 519 86522226 
9 XIHU ROAD, WUJIN Hi-Tech IndustrSE DECISION MADE: 18-NOV-15
Changzhou  CN 213168              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IdentEvent
OPTIMA NEUROSCIENCE, INC.         510(k) NO: K150688(Traditional)
ATTN: Ryan T. Kern                PHONE NO : 352 3718281 
11930 Research Circle             SE DECISION MADE: 05-NOV-15
Alachua FL  32615                 510(k) STATEMENT
                                                    

DEVICE: Gemini Sterilization Wrap
MEDLINE INDUSTRIES, INC.          510(k) NO: K150698(Traditional)
ATTN: Jennifer  Mason             PHONE NO : 847 6433652 
1 MEDLINE PLACE                   SE DECISION MADE: 20-NOV-15
MUNDELEIN IL  60060               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.CT Myocardial Perfusion
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K150713(Traditional)
ATTN: EVE  DAVIS                  PHONE NO : 610 2197133 
51 VALLEY STREAM PARKWAY, MC D02  SE DECISION MADE: 02-NOV-15
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Water Based Personal Lubricant with Flavours
KAREX INDUSTRIES SDN. BHD.        510(k) NO: K150743(Abbreviated)
ATTN: MS. MARY  GOH YIN           PHONE NO : 607 688 1996 
PTD 7906 & 7907, TAMAN PONTIAN JAYSE DECISION MADE: 12-NOV-15
PONTIAN  MY 82000                 510(k) STATEMENT
                                                    

DEVICE: REDAPT Porous Acetabular Shell and Cemented Liner
SMITH & NEPHEW, INC.              510(k) NO: K150790(Traditional)
ATTN: JEFF  SPRAGUE               PHONE NO : 1 901 3995215 
7135 GOODLETT FARMS PARKWAY       SE DECISION MADE: 16-NOV-15
CORDOVA TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel,  Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula
INNOVACYN, INC.                   510(k) NO: K150799(Traditional)
ATTN: Victor Torcat Mallen        PHONE NO : 909 8226000 302
3546 N. RIVERSIDE AVE.            SE DECISION MADE: 19-NOV-15
RIALTO CA  92377                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Valved Safety Centesis Catheter
B. Braun Medical Inc              510(k) NO: K150800(Traditional)
ATTN: Nancy  Skocypec             PHONE NO : 1 610 2660500 
901 Marcon Blvd                   SE DECISION MADE: 12-NOV-15
Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Collagen Dural Regeneration Matrix
COLLAGEN MATRIX, INC.             510(k) NO: K150825(Traditional)
ATTN: GLORIA   ZUCLICH            PHONE NO : 201 4051355 
15 THORNTON ROAD                  SE DECISION MADE: 20-NOV-15
OAKLAND NJ  07436                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO
HemCon Medical Technologies, Inc. 510(k) NO: K150916(Traditional)
ATTN: Jody  Oyama                 PHONE NO : 503 2450459 
720 SW Washington Street, Suite 20SE DECISION MADE: 10-NOV-15
Portland OR  97225                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Breast Pump
Guangzhou Jinxinbao Electronic Co.510(k) NO: K150923(Traditional)
ATTN: Jiacheng  Guo               PHONE NO : 086 20 34938449 
No.38 Huanzhen Xi Road,  Dagang ToSE DECISION MADE: 06-NOV-15
Guangzhou,Guangdong  CN 511470    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Contour Next USB Blood Glucose Monitoring System
BAYER HEALTHCARE                  510(k) NO: K150942(Special)
ATTN: JENNIFER L. GREGORY         PHONE NO : 1 574 2563447 
DIABETES CARE 430 SOUTH BEIGER STRSE DECISION MADE: 25-NOV-15
MISHAWAKA IN  46544               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AnsCare ChitoClot Pad
BENQ MATERIALS CORPORATION        510(k) NO: K150963(Traditional)
ATTN: Kenix  Chang                PHONE NO : 886 3 3748800 
NO. 29, JIANGUO E. RD GUISHAN     SE DECISION MADE: 05-NOV-15
TAOYUAN  TW 33341                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medihoney Wound Gel
DERMA SCIENCES, INC.              510(k) NO: K150985(Traditional)
ATTN: SHARMINI   ATHERAY          PHONE NO : 416 2994003 245
104 SHORTING ROAD                 SE DECISION MADE: 19-NOV-15
TORONTO, ONTARIO  CA M1S 3S4      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PULLUP® Adjustable Juxtacortical Fixation Device
SBM SCIENCES FOR BIO MATERIALS    510(k) NO: K151004(Traditional)
ATTN: DENIS  CLEMENT              PHONE NO : 33 5 62422101 
ZI DU MONGE                       SE DECISION MADE: 17-NOV-15
LOURDES  FR 65100                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SternaLock® 360 Sternal Closure System
BIOMET MICROFIXATION              510(k) NO: K151019(Traditional)
ATTN: LAUREN  JASPER              PHONE NO : 904 7419259 
1520 TRADEPORT DRIVE              SE DECISION MADE: 03-NOV-15
JACKSONVILLE FL  32218            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PainKARE
TrioWave Technologies             510(k) NO: K151034(Traditional)
ATTN: Huiyou  Zhu                 PHONE NO : 510 4701011 
3984 Washington Blvd #166         SE DECISION MADE: 21-NOV-15
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nihon Kohden CSM 1901 Bedside Monitor
Nihon Kohden                      510(k) NO: K151080(Traditional)
ATTN: Tom  Bento                  PHONE NO : 949 5801555 3324
15353 Barranca Parkway            SE DECISION MADE: 05-NOV-15
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AVAflex Vertebral Balloon System
CAREFUSION                        510(k) NO: K151125(Traditional)
ATTN: Joy  Greidanus              PHONE NO : 847 3628103 
75 NORTH FAIRWAY DRIVE            SE DECISION MADE: 24-NOV-15
VERNON HILLS IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FIBERGRAFT BG Morsels 
PROSIDYAN INC.                    510(k) NO: K151154(Traditional)
ATTN: CHARANPREET S BAGGA         PHONE NO : 908 5173666 
30 TECHNOLOGY DRIVE               SE DECISION MADE: 10-NOV-15
WARREN NJ  07059                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stay Fresh Hydrocolloid dressing
SARASOTA MEDICAL PRODUCTS, INC.   510(k) NO: K151186(Traditional)
ATTN: WALTER F. LEISE             PHONE NO : 941 3771451 
1451 SARASOTA CENTER BLVD.        SE DECISION MADE: 27-NOV-15
SARASOTA FL  34241                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OES ELITE Telescopes, Protective Tube
OLYMPUS WINTER & IBE GMBH         510(k) NO: K151191(Traditional)
ATTN: KATHARINA  SCHNACKENBURG    PHONE NO : 49 40 669662997 
KUEHNESTRASSE 61                  SE DECISION MADE: 24-NOV-15
HAMBURG  DE 22045                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InterOss
SigmaGraft, Inc                   510(k) NO: K151209(Traditional)
ATTN: Megan  Holden               PHONE NO : 714 5250114 
335 N. Puente St.  Unit A         SE DECISION MADE: 06-NOV-15
Brea CA  92821                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ziostation2
QI IMAGING, LLC                   510(k) NO: K151212(Traditional)
ATTN: RICHARD  BALL               PHONE NO : 650 4131364 
1235 RADIO ROAD, STE 110          SE DECISION MADE: 04-NOV-15
REDWOOD CITY CA  94065            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KYPHON XPEDE Bone Cement
MEDTRONIC                         510(k) NO: K151227(Traditional)
ATTN: KATHY L REMSEN              PHONE NO : 901 3963133 
1800 PYRAMID PLACE                SE DECISION MADE: 16-NOV-15
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: R350 guidewire
VASCULAR SOLUTIONS, INC.          510(k) NO: K151234(Traditional)
ATTN: BEKA  VITE                  PHONE NO : 1 763 6575732 
6464 Sycamore Court North         SE DECISION MADE: 18-NOV-15
Minneapolis MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System
SD BIOSENSOR                      510(k) NO: K151265(Traditional)
ATTN: YEON  PARK                  PHONE NO : 82 31 3000416 
C-4TH&5TH, 16, DEOGYEONG-DAERO, 15SE DECISION MADE: 24-NOV-15
 SUWON-SI  KR 363-951             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAKO Device
nVision Medical                   510(k) NO: K151275(Traditional)
ATTN: Surbhi  Sarna               PHONE NO : 408 6553577 
250 King Street, #676             SE DECISION MADE: 13-NOV-15
San Francisco CA  94107           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)
BIOS S.R.L.                       510(k) NO: K151296(Traditional)
ATTN: RICCARDO  PISATI            PHONE NO : 39 0227 304275 
VIA GUIDO ROSSA, 10/12            SE DECISION MADE: 19-NOV-15
VIMODRONE  IT I-20090             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K151315(Traditional)
ATTN: YINGYING   GAO              PHONE NO : 508 6834356 
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 10-NOV-15
MARLBOROUGH MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cytoflex Tefguard Ti-Enforced Membrane
Unicare Biomedical, Inc.          510(k) NO: K151344(Traditional)
ATTN: Stan  Yang                  PHONE NO : 949 3051770 
23011 Moulton Parkway, J-11       SE DECISION MADE: 19-NOV-15
Laguna Hills CA  92653            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nox RIP Belts & Cables
NOX MEDICAL ehf                   510(k) NO: K151361(Traditional)
ATTN: KOLBRUN  E OTTOSDOTTIR      PHONE NO : 354 570 7170 
KATRINARTUNI 2                    SE DECISION MADE: 06-NOV-15
REYKJAVIK  IS 105                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: superDimension Navigation System
Covidien LLC                      510(k) NO: K151376(Traditional)
ATTN: Jenny  Jiang                PHONE NO : 763 6475531 
161 Cheshire Lane, Suite 100      SE DECISION MADE: 05-NOV-15
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
Fujirebio Diagnostics, Inc.       510(k) NO: K151378(Traditional)
ATTN: Diana  Dickson              PHONE NO : 610 2403917 
201 Great Valley Parkway          SE DECISION MADE: 24-NOV-15
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Patient Contoured Implant-PEEK (PCI-PEEK)
KLS MARTIN L.P.                   510(k) NO: K151382(Traditional)
ATTN: JENNIFER  DAMATO            PHONE NO : 1 800 6251557 
11201 SAINT JOHNS INDUSTRIAL PKWY.SE DECISION MADE: 09-NOV-15
JACKSONVILLE FL  32246            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuViz 128 Multi-slice CT Scanner System
NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K151383(Traditional)
ATTN: TIAN  YUEHUI                PHONE NO : 86 24 83660646 
 NO.16, SHIJI ROAD, HUNNAN INDUSTRSE DECISION MADE: 04-NOV-15
SHENYANG  CN 110179               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System
NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K151403(Traditional)
ATTN: TIAN  YUEHUI                PHONE NO : 86 24 83660646 
NO. 16, SHIJI ROAD HUNNAN INDUSTRISE DECISION MADE: 02-NOV-15
SHENYANG  CN 110179               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IQQA Guide
EDDA TECHNOLOGY                   510(k) NO: K151414(Traditional)
ATTN: XIAOLAN  ZENG               PHONE NO : 609 9199889 
5 INDEPENDENCE WAY                SE DECISION MADE: 20-NOV-15
PRINCETON NJ  08540               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NaturalLine Abutment
OT MEDICAL GMBH                   510(k) NO: K151432(Traditional)
ATTN: MARTINA  BEHLAU             PHONE NO : 49 421 55716141 
KONSUL-SMIDT-STR. 8B              SE DECISION MADE: 05-NOV-15
BREMEN  DE D-28217                510(k) STATEMENT
                                                    

DEVICE: CORVUS Radiation Therapy Planning System
BEST NOMOS                        510(k) NO: K151469(Traditional)
ATTN: VINEET   GUPTA              PHONE NO : 412 312 6700
ONE BEST DRIVE                    SE DECISION MADE: 25-NOV-15
PITTSBURGH PA  15202              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency
FIRST QUALITY HYGIENIC, INC.      510(k) NO: K151470(Third Party - Abbreviated)
ATTN: Melanie  Leibowitz          PHONE NO : 516 4983665 
121 North Road                    SE DECISION MADE: 02-NOV-15
McElhattan PA  17748              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ICS Impulse
GN OTOMETRICS                     510(k) NO: K151504(Traditional)
ATTN: ANDERS  RASMUSSEN           PHONE NO : 1 847 5342150 
HOERSKAETTEN 9                    SE DECISION MADE: 16-NOV-15
TAATRUP  DK DK-2630               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Andersen EOGas 4 SteriTest
Andersen Sterilizers, Inc.        510(k) NO: K151585(Traditional)
ATTN: William  K Andersen         PHONE NO : 336 3768266 
3154 Caroline Drive               SE DECISION MADE: 18-NOV-15
Haw River NC  27258               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves
Lucenxia Prescience AG            510(k) NO: K151605(Traditional)
ATTN: Robert  Hill                PHONE NO : 41 417 689126 
Rathausstrasse  7                 SE DECISION MADE: 16-NOV-15
Baar  CH 6341                     510(k) STATEMENT
                                                    

DEVICE: Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
Lucenxia Prescience AG            510(k) NO: K151607(Traditional)
ATTN: Robert  Hill                PHONE NO : 41 417 689126 
Rathautrasse 7                    SE DECISION MADE: 16-NOV-15
Baar  CH 6341                     510(k) STATEMENT
                                                    

DEVICE: ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2
NDS SURGICAL IMAGING LLC          510(k) NO: K151609(Traditional)
ATTN: Jim  Leng                   PHONE NO : 408 7760085 
5750 HELLYER AVENUE               SE DECISION MADE: 06-NOV-15
SAN JOSE CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental 
MEDELA AG                         510(k) NO: K151632(Traditional)
ATTN: Orlando  Antunes            PHONE NO : 41 041 5616671 
LATTICHSTRASSE 4B                 SE DECISION MADE: 05-NOV-15
BAAR  CH 6341                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter
Cathera, Inc.                     510(k) NO: K151638(Traditional)
ATTN: Victor  Ham                 PHONE NO : 650 3885082 
627 National Ave.                 SE DECISION MADE: 13-NOV-15
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEARTWAY Power Mobility Scooter
HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K151656(Traditional)
ATTN: KE-MIN  JEN                 PHONE NO : 886 4 23580357 
NO.6, ROAD 25, TAICHUNG INDUSTRIALSE DECISION MADE: 25-NOV-15
TAICHUNG CITY  TW 40850           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm
Stryker                           510(k) NO: K151667(Traditional)
ATTN: Rhoda M Santos              PHONE NO : 510 4132269 
47900 BAYSIDE PARKWAY             SE DECISION MADE: 13-NOV-15
FREMONT CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K151673(Traditional)
ATTN: PAUL  BIGGINS               PHONE NO : 1 714 6697808 
1385 SHIMOISHIGAMI                SE DECISION MADE: 27-NOV-15
OTAWARA-SHI  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
HEZE YUZE GLOVE CO., LTD          510(k) NO: K151679(Traditional)
ATTN: LILY  ZHU                   PHONE NO : 86 530 2069709 
NO. 1 HANJIANG ROAD               SE DECISION MADE: 27-NOV-15
CAOXIAN  CN 274415                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Daxwell, LLC                      510(k) NO: K151682(Traditional)
ATTN: Frank  Zhang                PHONE NO : 281 6690622 
2825 Wilcrest Dr., Suite #500     SE DECISION MADE: 17-NOV-15
Houston TX  77042                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioArchitects Patient Specific Cranial/Craniofacial Plate
BioArchitects USA, LLC            510(k) NO: K151692(Traditional)
ATTN: Mark E. Ulrich              PHONE NO : 1 212 5354050 
219 East 69th Street Suite 2K     SE DECISION MADE: 20-NOV-15
New York NY  10021                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SNaP Wound Care System
SPIRACUR, INC.                    510(k) NO: K151710(Traditional)
ATTN: LAWRENCE  HU                PHONE NO : 1 408 7015300 
1180 BORDEAUX DRIVE               SE DECISION MADE: 19-NOV-15
SUNNYVALE CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LILLIPUP PMP, LILLIPUT PMP INTEGRATED
SORIN GROUP ITALIA S.R.L.         510(k) NO: K151713(Traditional)
ATTN: LUIGI  VECCHI               PHONE NO : 011 39 053529811 
86, VIA STATALE 12 NORD           SE DECISION MADE: 06-NOV-15
MIRANDOLA  IT 41037               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Aspiration Needle NA-U200H
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K151738(Traditional)
ATTN: TOSHIYUKI  NAKAJIMA         PHONE NO : 81 42 6422694 
2951 ISHIKAWA-CHO                 SE DECISION MADE: 20-NOV-15
HACHIOJI-SHI  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Revision Femoral Stem
LIMACORPORATE S.P.A.              510(k) NO: K151739(Traditional)
ATTN: EMANUELE  BUTTAZZONI        PHONE NO : 39 0432 945511 
VIA NAZIONALE 52                  SE DECISION MADE: 23-NOV-15
VILLANOVA DI SAN DANIELE  IT 33038510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOMATOM Emotion 6/16
Siemens Medical Solutions USA, Inc510(k) NO: K151752(Special)
ATTN: Eve  Davis                  PHONE NO : 610 2197133 
51 Valley Stream Parkway          SE DECISION MADE: 12-NOV-15
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS
THE BINDING SITE GROUP LTD.       510(k) NO: K151759(Traditional)
ATTN: STEPHANIE  THOULESS         PHONE NO : 44 0121 4569500 
8 CALTROPE ROAD                   SE DECISION MADE: 06-NOV-15
EDGBASTON  GB B15 1QT             510(k) STATEMENT
                                                    

DEVICE: YAMAHACHI PMMA DISKS
YAMAHACHI DENTAL PRODUCTS USA, INC510(k) NO: K151764(Traditional)
ATTN: LAWRENCE G. GREENWALD       PHONE NO : 973 3202909 
160 PARK AVENUE                   SE DECISION MADE: 23-NOV-15
NUTLEY NJ  07110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Libra Pedicle Screw System
Spinal Balance Inc.               510(k) NO: K151770(Traditional)
ATTN: Anand  Agarwal              PHONE NO : 419 5305940 
1510 North Westwood Avenue        SE DECISION MADE: 20-NOV-15
Toledo OH  43606                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CONCORDE Bullet Lumbar Interbody System
Medos International, Sarl         510(k) NO: K151773(Traditional)
ATTN: JACLYN  PORSOLT             PHONE NO : 508 8283269 
Chemin-Blanc 38                   SE DECISION MADE: 20-NOV-15
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K151791(Special)
ATTN: JAIME  LEE                  PHONE NO : 800 2623304 7650
125 BLUE BALL ROAD                SE DECISION MADE: 19-NOV-15
ELKTON MD  21921                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System
Siemens Healthcare Diagnostics,Inc510(k) NO: K151792(Traditional)
ATTN: Philip  Liu                 PHONE NO : 914 5242443 
511 Benedict Avenue               SE DECISION MADE: 20-NOV-15
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System
PRISMATIK DENTALCRAFT, INC.       510(k) NO: K151798(Traditional)
ATTN: ARMIN  ZEHTABCHI            PHONE NO : 949 2251234 
2212 DUPONT DRIVE, SUITE P        SE DECISION MADE: 16-NOV-15
IRVINE CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TLC-2000 Therapeutic Medical Laser System
Theralase Inc.                    510(k) NO: K151816(Traditional)
ATTN: Roger  Dumoulin-White       PHONE NO : 416 6995273 
1945 Queen Street East            SE DECISION MADE: 19-NOV-15
Toronto  CA                       510(k) STATEMENT
                                                    

DEVICE: Integrity Spine Lumbar Interbody Fusion System
INTEGRITY SPINE LUMBAR INTERBODY F510(k) NO: K151819(Traditional)
ATTN: LISA  PETERSON              PHONE NO : 512 5070746 
2800 NE LOOP 410 SUITE 203        SE DECISION MADE: 10-NOV-15
SAN ANTONIO TX  78218             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Viradius Neurowire
MIVI NEUROSCIENCE, INC.           510(k) NO: K151825(Traditional)
ATTN: RANDY  LABOUNTY             PHONE NO : 952 9443834 
6545 CITY WEST PARKWAY            SE DECISION MADE: 16-NOV-15
EDEN PRAIRIE MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PacEndo Sodium Hyprochlorite
PAC-DENT INTERNATIONAL, INC.      510(k) NO: K151852(Traditional)
ATTN: WENYING  ZHU                PHONE NO : 909 8390888 
670 ENDEAVOR CIRCLE               SE DECISION MADE: 10-NOV-15
BREA CA  92821                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avance Y-Connector S
MOLNLYCKE HEALTH CARE, US LLC     510(k) NO: K151872(Traditional)
ATTN: ANGELA  BUNN                PHONE NO : 470 3750048 
5550 PEACHTREE PARKWAY, SUITE 500 SE DECISION MADE: 02-NOV-15
NORCROSS GA  30092                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AirView
RESMED LTD.                       510(k) NO: K151901(Traditional)
ATTN: Jasjit  Baveja              PHONE NO : 61 28884 1000 
1 ELIZABETH MACARTHUR DRIVE       SE DECISION MADE: 05-NOV-15
BELLA VISTA  AU 2153              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Slendertone connect Abs
BIO-MEDICAL RESEARCH LTD.         510(k) NO: K151903(Traditional)
ATTN: ANNE-MARIE  KEENAN          PHONE NO : 353 91 774316 
PARKMORE BUSINESS PARK WEST       SE DECISION MADE: 06-NOV-15
GALWAY  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elation Wireguided Balloon Dilation Catheter
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K151925(Traditional)
ATTN: DAVID  THOMAS               PHONE NO : 801 3164956 
1600 WEST MERIT PARKWAY           SE DECISION MADE: 06-NOV-15
SOUTH JORDAN UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PUR Dental Implant System
STERNGOLD DENTAL, LLC             510(k) NO: K151928(Abbreviated)
ATTN: MARIA  RAO                  PHONE NO : 508 2265660 
23 FRANK MOSSBERG DR              SE DECISION MADE: 06-NOV-15
ATTLEBORO MA  02703               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thermofit
ORFIT INDUSTRIES                  510(k) NO: K151946(Traditional)
ATTN: EDDY  MAROVOET              PHONE NO : 32 03 3262026 
VOSVELD 9A, B-2110 WIJNEGEM       SE DECISION MADE: 09-NOV-15
WIJNEGEM, BELGIUM  BE             510(k) STATEMENT
                                                    

DEVICE: Polaris Spinal System
BIOMET SPINE                      510(k) NO: K151974(Traditional)
ATTN: ALEXANDRA  BECK             PHONE NO : 303 5018397 
310 INTERLOCKEN PARKWAY, SUITE 120SE DECISION MADE: 13-NOV-15
BROOMFIELD CO  80021              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control
ZIMMER, INC.                      510(k) NO: K151992(Traditional)
ATTN: PATRICK  MCCULLAGH          PHONE NO : 574 3724656 
P.O. BOX 708                      SE DECISION MADE: 02-NOV-15
WARSAW IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMV Scientific Bone Plate and Screw System
SMV Scientific                    510(k) NO: K152000(Traditional)
ATTN: Nephi  Zufelt               PHONE NO : 512 7508622 
111 Sandra Muraida Way Unit 18A   SE DECISION MADE: 25-NOV-15
Austin TX  78703                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nanova Universal Composite
NANOVA BIOMATERIALS INC           510(k) NO: K152004(Traditional)
ATTN: ANDREW  RITTS               PHONE NO : 573 8233114 
3806 MOJAVE CT                    SE DECISION MADE: 17-NOV-15
COLUMBIA MO  65202                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HairMD
TROPHY SKIN, INC.                 510(k) NO: K152019(Traditional)
ATTN: IMRAN  KARIM                PHONE NO : 469 2331768 
4372 KENMORE TRAIL                SE DECISION MADE: 16-NOV-15
FRISCO TX  75034                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Renaissance X System
Mazor Robotics Ltd.               510(k) NO: K152041(Special)
ATTN: Ayelet  Matia               PHONE NO : 972 4 6187100 
PO Box 3104, 7 HaEshel St.        SE DECISION MADE: 17-NOV-15
Caesarea Park South  IL 3088900   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)
ART OPTICAL CONTACT LENS, INC.    510(k) NO: K152046(Traditional)
ATTN: MICHAEL  JOHNSON            PHONE NO : 800 5668001 
3175 3175 3 MILE ROAD             SE DECISION MADE: 24-NOV-15
WALKER MI  49534                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ceramax Skin Barrier Cream
OCULUS INNOVATIVE SCIENCES        510(k) NO: K152055(Traditional)
ATTN: BRIAN W. MARTIN             PHONE NO : 707 2830550 
1129 N. MCDOWELL BOULEVARD        SE DECISION MADE: 23-NOV-15
PETALUMA CA  94954                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OsteoCool V-3 RF Ablation System
BAYLIS MEDICAL COMPANY INC.       510(k) NO: K152057(Traditional)
ATTN: MEGHAL  KHAKHAR             PHONE NO : 905 6024875 
2645 MATHESON BLVD. EAST          SE DECISION MADE: 24-NOV-15
MISSISSAUGA  CA L4W 5S4           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyvek Sterilization Pouches with Chevron Seal
Andersen Sterilizers,Inc.         510(k) NO: K152058(Traditional)
ATTN: William K Andersen          PHONE NO : 336 3768622 
3154 Caroline Drive               SE DECISION MADE: 18-NOV-15
Haw River NC  27258               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ponto bone anchored hearing system
OTICON MEDICAL AB                 510(k) NO: K152067(Traditional)
ATTN: Carolina Anker Wessling     PHONE NO : 46 31 7486100 
DATAVAGEN 37B                     SE DECISION MADE: 23-NOV-15
ASKIM  SE 436 32                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: e-1 etchants
E DENTAL PRODUCTS                 510(k) NO: K152110(Traditional)
ATTN: JEFF  BANYAS                PHONE NO : 423 4263221 
216 W. WATAUGA AVE.               SE DECISION MADE: 20-NOV-15
JOHNSON CITY TN  37604            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FDR D-EVO GL Flat Panel Detector System
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K152138(Traditional)
ATTN: Katherine Y Choi            PHONE NO : 203 6023568 
419 WEST AVENUE                   SE DECISION MADE: 05-NOV-15
STAMFORD CT  06902                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ATAL 9
ATLAIM CORPORATION                510(k) NO: K152151(Special)
ATTN: JOHN  ROSS                  PHONE NO : 82 70 48468888 
5F, SMARTBAY. 123, BEOLMAL-RO, DONSE DECISION MADE: 10-NOV-15
ANYANG-SI  KR 431-804             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Turbo-Power Laser Atherectomy Catheter
SPECTRANETICS, INC.               510(k) NO: K152181(Traditional)
ATTN: Priscila  Tapia             PHONE NO : 719 4472587 
9965 FEDERAL DRIVE                SE DECISION MADE: 12-NOV-15
COLORADO SPRINGS CO  80921        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EXELINT SecureTouch Safety Hypodermic Needle
EXELINT INTERNATIONAL CO.         510(k) NO: K152183(Traditional)
ATTN: Navid  Hamid                PHONE NO : 310 6490707 
2500 Santa Fe Avenue              SE DECISION MADE: 02-NOV-15
Redondo Beach CA  90278           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UTERMOHLEN CRYO PROFESSIONAL
KONINKLIJKE (ROYAL) UTERMOHLEN    510(k) NO: K152203(Traditional)
ATTN: MR.D   VAN HOOF             PHONE NO : 31 561 693359 
DEE OVERWEG 1                     SE DECISION MADE: 06-NOV-15
WOLVEGA  NL 8471ZA                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Edwards eSheath Introducer Set
EDWARDS LIFESCIENCES              510(k) NO: K152225(Traditional)
ATTN: KAREN  REYNOLDS             PHONE NO : 1 949 2502295 
1 EDWARDS WAY                     SE DECISION MADE: 24-NOV-15
IRVINE CA  92614-5686             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KATOR Suture Anchor
KATOR LLC                         510(k) NO: K152236(Traditional)
ATTN: Robert  Hoy                 PHONE NO : 614 4486358 
124 South 600 West, Suite 100     SE DECISION MADE: 04-NOV-15
Logan UT  84321                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: G3¿ Active Plate® Large Fragment System
GENESIS FRACTURE CARE, INC.       510(k) NO: K152242(Traditional)
ATTN: MICHAEL  BOTTLANG           PHONE NO : 503 5284048 
13568 SE 97TH AVE., SUITE 202     SE DECISION MADE: 24-NOV-15
CLACKAMAS OR  97105               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CD HORIZON Spinal System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K152248(Traditional)
ATTN: Becky  Ronner               PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 05-NOV-15
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex iBalance TKA System
ARTHREX, INC.                     510(k) NO: K152252(Traditional)
ATTN: LEON  BROWN                 PHONE NO : 239 6435553 72028
1370 CREEKSIDE BLVD               SE DECISION MADE: 16-NOV-15
NAPLES FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BoneCam Suture Anchors
VALERIS MEDICAL                   510(k) NO: K152255(Traditional)
ATTN: DANIEL   LANOIS             PHONE NO : 888 4043980 101
200 COBB PKW N, BLDG 200, STE 210 SE DECISION MADE: 16-NOV-15
MARIETTA GA  30062                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws
NORMED MEDIZIN-TECHNIK GMBH       510(k) NO: K152256(Traditional)
ATTN: ARNE  BRIEST                PHONE NO : 49 7461 93430 
ULRICHSTRASSE 7                   SE DECISION MADE: 05-NOV-15
TUTTLINGEN  DE D-78532            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InFill Interbody Fusion Device
Pinnacle Spine Group, LLC         510(k) NO: K152259(Traditional)
ATTN: Rebecca K Pine              PHONE NO : 760 8095178 
1601 Elm Street  Suite 1930       SE DECISION MADE: 19-NOV-15
Dallas TX  75201                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Denture base resin
KOREA ENGINEERING PLASTICS CO., LT510(k) NO: K152270(Traditional)
ATTN: SONG-YI  CHONG              PHONE NO : 82 31 6893615 
216,217,218, B BLDG, 17, GOSAN-RO SE DECISION MADE: 13-NOV-15
GUNPO-SI  KR 435-833              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arrow Endurance Extended Dwell Peripheral Catheter System
ARROW INTERNATIONAL, INC. (SUBSIDI510(k) NO: K152272(Traditional)
ATTN: TRACY  LARISH               PHONE NO : 610 3780131 
2400 BERNVILLE RD                 SE DECISION MADE: 23-NOV-15
READING PA  19605                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PIVOX(tm) Oblique Lateral Spinal System
MEDTRONIC SOFAMOR DANEK USA, INC  510(k) NO: K152277(Traditional)
ATTN: Lila  Joe                   PHONE NO : 901 3963133 
1800 PYRAMID PLACE                SE DECISION MADE: 13-NOV-15
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cam Lock Plating System 
LIFE SPINE, INC                   510(k) NO: K152282(Traditional)
ATTN: RANDY  LEWIS                PHONE NO : 847 8846117 
13951 S. Quality Drive            SE DECISION MADE: 20-NOV-15
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: illumigene Pertussis DNA Amplification Assay
MERIDIAN BIOSCIENCE, INC.         510(k) NO: K152285(Traditional)
ATTN: SUSAN  ROLIH                PHONE NO : 513 2713700 
3471 River Hills Dr               SE DECISION MADE: 10-NOV-15
CINCINNATI OH  45244              510(k) STATEMENT
                                                    

DEVICE: Talon DistalFix Antegrade/Retrograde Femoral Nail
ORTHOPEDIC DESIGNS NORTH AMERICA, 510(k) NO: K152295(Traditional)
ATTN: Robin  Wilson               PHONE NO : 813 4434905 
5912 BRECKENRIDGE PARKWAY SUITE F SE DECISION MADE: 03-NOV-15
TAMPA FL  33610                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base
MICROPORT ORTHOPEDICS, INC.       510(k) NO: K152298(Traditional)
ATTN: BYRON  LEDBETTER            PHONE NO : 901 2905943 
5677 AIRLINE ROAD                 SE DECISION MADE: 16-NOV-15
ARLINGTON TN  38002               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tritanium PL Cage
Stryker                           510(k) NO: K152304(Traditional)
ATTN: SIMONA  VOIC                PHONE NO : 201 7608033 
2 PEARL COURT                     SE DECISION MADE: 19-NOV-15
ALLENDALE NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MD-2300S Ultrasonic A/B Scanner for Ophthalmology
MEDA CO.,LTD                      510(k) NO: K152318(Traditional)
ATTN: Yusheng  ZHANG              PHONE NO : 86 22 83713808 
F2C,F3D,F4C,F5,F6C,BLDG C2,Xinmao SE DECISION MADE: 17-NOV-15
TIANJIN  CN 300384                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Star+ VPS Scannable Impression Material
DANVILLE MATERIALS LLC            510(k) NO: K152349(Traditional)
ATTN: DONG  HUA                   PHONE NO : 925 9730710 
3420 FOSTORIA WAY SUITE A-200     SE DECISION MADE: 23-NOV-15
SAN RAMON CA  94583               510(k) STATEMENT
                                                    

DEVICE: Arthrex iBalance TKA System
ARTHREX, INC.                     510(k) NO: K152382(Special)
ATTN: LEON  BROWN                 PHONE NO : 239 6435553 72028
1370 CREEKSIDE BOULEVARD          SE DECISION MADE: 12-NOV-15
NAPLES FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wrist - Type Fully Automatic Digital Blood Pressure Monitor
SEJOY ELECTRONICS & INSTRUMENTS CO510(k) NO: K152426(Special)
ATTN: REN  YUNHUA                 PHONE NO : 86 571 81957767 
BUILDING 2, NO.202, ZHENZHONG ROADSE DECISION MADE: 09-NOV-15
HANGZHOU  CN 310030               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XprESS Multi-Sinus Dilation System
ENTELLUS MEDICAL, INC.            510(k) NO: K152434(Traditional)
ATTN: KAREN E. PETERSON           PHONE NO : 763 4637066 
3600 HOLLY LANE NORTH, SUITE 40   SE DECISION MADE: 20-NOV-15
PLYMOUTH MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PassAssist LED Light Fiber
ENTELLUS MEDICAL, INC.            510(k) NO: K152435(Traditional)
ATTN: KAREN E. PETERSON           PHONE NO : 763 4637066 
3600 HOLLY LANE NORTH, SUITE 40   SE DECISION MADE: 20-NOV-15
PLYMOUTH MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DERMABOND PRINEO Skin Closure System
ETHICON, INC.                     510(k) NO: K152490(Traditional)
ATTN: DONNA  MARSHALL             PHONE NO : 908 5413990 
ROUTE 22 WEST, P.O. BOX 151       SE DECISION MADE: 25-NOV-15
SOMERVILLE NJ  08876-0151         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments
ZIMMER, INC.                      510(k) NO: K152494(Traditional)
ATTN: MARK D WARNER               PHONE NO : 574 3724150 
P.O. BOX 708                      SE DECISION MADE: 25-NOV-15
WARSAW IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wondfo Propoxyphene Urine Test
Guangzhou Wondfo Biotech Co., Ltd.510(k) NO: K152495(Traditional)
ATTN: Ben  Chen                   PHONE NO : 86 20 32296069 
Wondfo Scientech Park, South ChinaSE DECISION MADE: 23-NOV-15
Guangzhou  CN 510641              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clickfine AutoProtect Pen Needle
YPSOMED AG                        510(k) NO: K152514(Special)
ATTN: STEPHAN  AFFOLTER           PHONE NO : 0041 34 4243382 
BRUNNMATTSTRASSE 6                SE DECISION MADE: 18-NOV-15
BURGDORF  CH CH - 3401            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vonflex S Putty
VERICOM CO., LTD                  510(k) NO: K152518(Traditional)
ATTN: MYUNG-HWAN  OH              PHONE NO : 82 31 4412881 
48, TOEGYEGONGDAN 1-GIL           SE DECISION MADE: 30-NOV-15
CHUNCHEON-SI  KR 200-944          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TR BAND Radial Compression Device
TERUMO MEDICAL CORPORATION        510(k) NO: K152525(Traditional)
ATTN: LIANG  LU                   PHONE NO : 410 3927321 
950 ELKTON BLVD                   SE DECISION MADE: 10-NOV-15
ELKTON MD  21921                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test.
W.H.P.M., INC.                    510(k) NO: K152551(Traditional)
ATTN: JOHN  WAN                   PHONE NO : 626 4438480 
5358 IRWINDALE AVE.               SE DECISION MADE: 09-NOV-15
IRWINDALE CA  91706               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System
GE Healthcare                     510(k) NO: K152567(Special)
ATTN: Ayesha  Pergadia            PHONE NO : 314 3307043 
3114 N. Grandview Blvd.           SE DECISION MADE: 06-NOV-15
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bovie J-Plasma Precise 360 Handpiece
BOVIE MEDICAL CORPORATION         510(k) NO: K152570(Traditional)
ATTN: BRIAN  KUNST                PHONE NO : 727 8038617 
5115 ULMERTON ROAD                SE DECISION MADE: 02-NOV-15
CLEARWATER FL  33760              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 4Sight
ACCUTOME, INC.                    510(k) NO: K152573(Traditional)
ATTN: ADAM  PICKHOLTZ             PHONE NO : 610 8890200 
3222 PHOENIXVILLE PIKE            SE DECISION MADE: 25-NOV-15
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: rescuenet
ENDOCHOICE, INC.                  510(k) NO: K152580(Traditional)
ATTN: DANIEL  HOEFER              PHONE NO : 678 7084420 
11810 WILLS RD.                   SE DECISION MADE: 03-NOV-15
ALPHARETTA GA  30009              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROBEAT-V
Hitachi, Ltd.,Health Care Company 510(k) NO: K152592(Traditional)
ATTN: NAOYA  NISHIMURA            PHONE NO : 81 345 643563 
4-14-1 Sotokanda, Chiyoda-ku      SE DECISION MADE: 02-NOV-15
Tokyo  JP 101-8010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PANTHER Cutter Stapler
B. J. ZH. F. PANTHER MEDICAL EQUIP510(k) NO: K152618(Traditional)
ATTN: LINA  YUN                   PHONE NO : 86 010 80789058 
ROOM 3305A, FLOOR 3, BLDG 3, NO.20SE DECISION MADE: 12-NOV-15
BEIJING  CN 100102                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ATLANTIS Anterior Cervical Plate System
MEDTRONIC SOFAMOR DANEK USA, INC  510(k) NO: K152623(Traditional)
ATTN: LAVEEDA  LEFLORE            PHONE NO : 901 3463133 
1800 PYRAMID PLACE                SE DECISION MADE: 12-NOV-15
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pi Drive Plus Motor, Extender
STRYKER CORPORATION               510(k) NO: K152641(Special)
ATTN: DEVAL  PATEL                PHONE NO : 269 3895671 
400 E. MILHAM AVENUE              SE DECISION MADE: 20-NOV-15
KALAMAZOO MI  49001               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana
NANTONG EGENS BIOTECH CO., LTD.   510(k) NO: K152643(Traditional)
ATTN: Yan  Cao                    PHONE NO : 86 513 85327458 
BUILDING 15, 1692 XINGHU AVENUE   SE DECISION MADE: 02-NOV-15
NANTONG  CN 226010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HICAT Air
HICAT GmbH                        510(k) NO: K152661(Traditional)
ATTN: Frederik  Kunze             PHONE NO : 49 228 85469738 
Brunnenallee 6                    SE DECISION MADE: 16-NOV-15
Bonn  DE 53177                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TYRX Neuro Antibacterial Envelope
TYRX, INC.                        510(k) NO: K152678(Traditional)
ATTN: REGINA  NOVAK               PHONE NO : 732 9641492 
1 DEER PARK DRIVE SUITE G         SE DECISION MADE: 17-NOV-15
MONMOUTH JUNCTION NJ  08852       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 8 CH Knee SPEEDER 
QUALITY ELECTRODYNAMICS, LLC.     510(k) NO: K152695(Traditional)
ATTN: KATHLEEN  ARAS              PHONE NO : 440 4842964 
700 BETA DRIVE STE 100            SE DECISION MADE: 18-NOV-15
MAYFIELD VILLAGE OH  44143        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Parcus GFS Naked
PARCUS MEDICAL, LLC               510(k) NO: K152711(Special)
ATTN: PAUL  VAGTS                 PHONE NO : 941 7557965 
6423 PARKLAND DR                  SE DECISION MADE: 20-NOV-15
SARASOTA FL  34243                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 8MP Color LCD Monitor, RadiForce RX850, RX850-AR
EIZO CORPORATION                  510(k) NO: K152713(Traditional)
ATTN: HIROAKI  HASHIMOTO          PHONE NO : 81 76 2742468 
153 SHIMOKASHIWANO                SE DECISION MADE: 20-NOV-15
HAKUSAN  JP 924-8566              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
HOLOGIC, INC                      510(k) NO: K152723(Special)
ATTN: CATHERINE  EATON            PHONE NO : 508 2638604 
250 CAMPUS DRIVE                  SE DECISION MADE: 13-NOV-15
MARLBOROUGH MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Radifocus Glidewire
ASHITAKA FACTORY OF TERUMO CORP.  510(k) NO: K152740(Traditional)
ATTN: PHEBE  VARGHESE             PHONE NO : 732 4124166 
150 MAIMAIGI-CHO                  SE DECISION MADE: 16-NOV-15
FUJINOMIYA SHIZUOKA  JP 418-0015  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIGN Hip Construct (SHC)
SIGN FRACTURE CARE INTERNATIONAL  510(k) NO: K152757(Traditional)
ATTN: Rob  Teeter                 PHONE NO : 509 3711107 
451 Hills Street, Suite B         SE DECISION MADE: 13-NOV-15
Richland WA  99354                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venue 50 
GE MEDICAL SYSTEMS ULTRASOUND AND 510(k) NO: K152758(Traditional)
ATTN: TRACEY  ORTIZ               PHONE NO : 262 6766120 
9900 W. INNOVATION DR.            SE DECISION MADE: 18-NOV-15
WAUWATOSA WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G)
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K152761(Special)
ATTN: MARCIA  PAGE                PHONE NO : 206 2540600 
2101 4TH AVE, SUITE 100           SE DECISION MADE: 25-NOV-15
SEATTLE WA  98121                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fogarty Occlusion Catheter
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K152762(Traditional)
ATTN: Naren  Murugan              PHONE NO : 949 2502661 
ONE EDWARDS WAY                   SE DECISION MADE: 23-NOV-15
IRVINE CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avex CX2
Opal Orthodontics by Ultradent Pro510(k) NO: K152779(Special)
ATTN: Marie  Hess                 PHONE NO : 801 5534610 
505 West 10200 South              SE DECISION MADE: 25-NOV-15
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XIDF-AWS801, Angio Workstation, V6.20
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K152785(Traditional)
ATTN: PAUL  BIGGINS               PHONE NO : 714 6697808 
1385 SHIMOISHIGAMI                SE DECISION MADE: 25-NOV-15
OTAWARA-SHI  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VidiStar HeartView 
VIDISTAR, LLC                     510(k) NO: K152822(Traditional)
ATTN: CRAIG  WALKER               PHONE NO : 864 9791767 
PO BOX 8539                       SE DECISION MADE: 25-NOV-15
GREENVILLE SC  29604              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Visions PV.014P RX Digital IVUS Catheter
Volcano Corporation               510(k) NO: K152829(Special)
ATTN: Mary  Stanners              PHONE NO : 858 7641296 
3721 Valley Centre Drive, Suite 50SE DECISION MADE: 19-NOV-15
San Diego CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50
HARDY DIAGNOSTICS                 510(k) NO: K152838(Traditional)
ATTN: WENDY  HADLEY               PHONE NO : 805 3462766 5686
1430 WEST MCCOY LANE              SE DECISION MADE: 24-NOV-15
SANTA MARIA CA  93455             510(k) STATEMENT
                                                    

DEVICE: Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws
ZIMMER, INC.                      510(k) NO: K152841(Traditional)
ATTN: DOROTHY  SNYDER             PHONE NO : 574 3724092 
P.O BOX 708                       SE DECISION MADE: 24-NOV-15
WARSAW IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40
HARDY DIAGNOSTICS                 510(k) NO: K152846(Traditional)
ATTN: WENDY  HADLEY               PHONE NO : 805 3462766 5686
1430 WEST MCCOY LANE              SE DECISION MADE: 24-NOV-15
SANTA MARIA CA  93455             510(k) STATEMENT
                                                    

DEVICE: DIVA ZSP5812CMI with QUBYX PerfectLum bundle
QUBYX LTD.                        510(k) NO: K152847(Traditional)
ATTN: MARC  LEPPLA                PHONE NO : 33 0180 963820 
80, RUE MARECHAL JOFFRE           SE DECISION MADE: 17-NOV-15
NICE  FR 06000                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AUTOLAP SYSTEM
M.S.T Medical Surgery Technologies510(k) NO: K152848(Traditional)
ATTN: Tami  Harel                 PHONE NO : 972 73 7965570 
Kochav Yokneam Building, floor 5, SE DECISION MADE: 17-NOV-15
Yokneam llit  IL 2069200          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary 
BOSTON SCIENTIFIC CORP.           510(k) NO: K152853(Traditional)
ATTN: CARAH  KUCHARSKI            PHONE NO : 763 2550738 
ONE SCIMED PLACE                  SE DECISION MADE: 20-NOV-15
MAPLE GROVE MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD ChloraShield IV Dressing with CHG Antimicrobial
AVERY DENNISON BELGIE BVBA        510(k) NO: K152923(Special)
ATTN: LISA  BARTAKOVICS           PHONE NO : 312 6294608 
TIEBLOKKENLAAN 1                  SE DECISION MADE: 05-NOV-15
TURNHOUT  BE B-2300               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Multitom Rax 
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K152928(Traditional)
ATTN: DARREN A. DORMAN            PHONE NO : 
40 LIBERTY BLVD                   SE DECISION MADE: 13-NOV-15
MALVERN PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sirius Max Dental Diode Curing Light
NATIONAL DENTAL INC.              510(k) NO: K152936(Third Party - Traditional)
ATTN: EDWIN  FIRST                PHONE NO : 800 3921171 
3-149 COLLIER ST.                 SE DECISION MADE: 13-NOV-15
BARRIE  CA L4M 1H6                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Picasso Plus, Picasso Lite Plus
AMD GROUP LLC                     510(k) NO: K152939(Special)
ATTN: SCOTT A. EDWARDS            PHONE NO : 866 9992635 
7405 WESTFIELD BLVD.              SE DECISION MADE: 25-NOV-15
INDIANAPOLIS IN  46240            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K152953(Special)
ATTN: Denise  Oppermann           PHONE NO : 781 6994479 
920 Winter Street                 SE DECISION MADE: 05-NOV-15
Waltham MA  02451-1457            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HS70A Diagnostic Ultrasound System
SAMSUNG MEDISON CO., LTD.         510(k) NO: K152962(Third Party - Traditional)
ATTN: KYEONG-MI  PARK             PHONE NO : 82 2 21941373 
42, TEHERAN-RO 108-GIL            SE DECISION MADE: 02-NOV-15
GANGNAM-GU  KR 135-280            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VLP Mini-Mod Talus Plates
Smith & Nephew, Inc.              510(k) NO: K152976(Special)
ATTN: Samantha  Staubach          PHONE NO : 901 3996132 
1450 Brooks Road                  SE DECISION MADE: 12-NOV-15
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM SonoSite iViz Ultrasound System
FUJIFILM SONOSITE,INC.            510(k) NO: K152983(Third Party - Traditional)
ATTN: PATRICIA  LIAU              PHONE NO : 425 9516870 
21919 30th Dr SE                  SE DECISION MADE: 12-NOV-15
BOTHELL WA  98021-3904            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Philips IntelliSpace Cardiovascular
PHILIPS MEDICAL SYSTEMS NETHRLANDS510(k) NO: K153022(Third Party - Traditional)
ATTN: Dave J.W. Bierhuizen        PHONE NO : 31 40 2764366 
VEENPLUIS 4-6                     SE DECISION MADE: 18-NOV-15
BEST  NL 5684 PC                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Ablatherm Integrated Imaging
EDAP TECHNOMED, INC.              510(k) NO: K153023(Traditional)
ATTN: MARC  OCZACHOWSKI           PHONE NO : 512 8327956 
2201 DENTON DR., SUITE 110        SE DECISION MADE: 06-NOV-15
AUSTIN TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RANGE/DENALI/MESA Spinal System
K2M, Incorporated                 510(k) NO: K153031(Special)
ATTN: NANCY  GIEZEN               PHONE NO : 571 9192000 
751 MILLER DRIVE SE               SE DECISION MADE: 17-NOV-15
LEESBURG VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LithoVue System
BOSTON SCIENTIFIC CORPORATION     510(k) NO: K153049(Third Party - Traditional)
ATTN: JEANNE  O'TOOLE             PHONE NO : 508 6834271 
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 13-NOV-15
MARLBOROUGH MA  01756             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors
CARERAY DIGITAL MEDICAL SYSTEM CO.510(k) NO: K153058(Special)
ATTN: LEILEI  LI                  PHONE NO : 86 512 86860288 
A2-201/B3-501, BIOBAY, 218 XINGHU SE DECISION MADE: 10-NOV-15
SUZHOU  CN 215123                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S
RAYENCE CO., LTD                  510(k) NO: K153060(Special)
ATTN: KEVIN  KIM                  PHONE NO : 82 31 80156459 
14, SAMSUNG 1-RO, 1-GIL           SE DECISION MADE: 10-NOV-15
HWASEONG-SI  KR 445-170           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UroNav (Version 2.0)
INVIVO CORPORATION                510(k) NO: K153073(Third Party - Traditional)
ATTN: Kenneth  Revennaugh         PHONE NO : 352 3848590 
3545 SW 47TH AVE.                 SE DECISION MADE: 16-NOV-15
GAINESVILLE FL  32608             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Klassic Knee System
TOTAL JOINT ORTHOPEDICS, INC.     510(k) NO: K153075(Special)
ATTN: Chris   Weaber              PHONE NO : 801 4866070 
1567 E. Stratford Avenue          SE DECISION MADE: 13-NOV-15
Salt Lake City UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RX ACCUNET Embolic Protection System
ABBOTT VASCULAR                   510(k) NO: K153086(Special)
ATTN: Aruna   Akkapeddi           PHONE NO : 408 8451648 
3200, LAKESIDE DRIVE              SE DECISION MADE: 20-NOV-15
SANTA CLARA CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LARIAT RS Suture Delivery Device
SentreHEART, Inc.                 510(k) NO: K153096(Special)
ATTN: KIT  CARIQUITAN             PHONE NO : 650 2416038 
300 Saginaw Drive                 SE DECISION MADE: 25-NOV-15
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BladderScan Prime System
VERATHON INCORPORATED             510(k) NO: K153101(Third Party - Traditional)
ATTN: Rhonda M Kops               PHONE NO : 425 8671348 5643
20001 NORTH CREEK PKWY            SE DECISION MADE: 19-NOV-15
BOTHEL WA  98011                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: QuadraSphere Microspheres
BIOSPHERE MEDICAL, S.A.           510(k) NO: K153102(Special)
ATTN: Alix  Fonlladosa            PHONE NO : 33 14817 2529 
Parc des Nations-Paris Nord 2, 383SE DECISION MADE: 23-NOV-15
Roissy en France  FR 95700        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Univers Apex, Size 5 Stem
ARTHREX, INC.                     510(k) NO: K153115(Special)
ATTN: COURTNEY  SMITH             PHONE NO : 239 6435553 71720
1370 CREEKSIDE BOULEVARD          SE DECISION MADE: 23-NOV-15
NAPLES FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carestream DRX-1 System with DRX Plus 4343 Detectors
CARESTREAM HEALTH, INC.           510(k) NO: K153142(Traditional)
ATTN: VICTORIA  WHEELER           PHONE NO : 585 6278706 
150 Verona Street                 SE DECISION MADE: 25-NOV-15
ROCHESTER NY  14608               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000
Inova Diagnostics, Inc.           510(k) NO: K153150(Special)
ATTN: Gabriella  Lakos            PHONE NO : 858 5869900 1393
9900 Old Grove Road               SE DECISION MADE: 24-NOV-15
San Diego CA  92131               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyber Medical MST Trauma Screw
TYBER MEDICAL LLC                 510(k) NO: K153180(Special)
ATTN: Mark F. Schenk              PHONE NO : 610 5078255 
89 HEADQUARTERS PLAZA NORTH #1464 SE DECISION MADE: 25-NOV-15
MORRISTOWN NJ  07960              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SELF- COMPRESSIVE SCREW
NEOSTEO                           510(k) NO: K153182(Traditional)
ATTN: JD  WEBB                    PHONE NO : 33 023 6569670 
2 RUE ROBERT SCHUMAN              SE DECISION MADE: 25-NOV-15
REZE  FR 44 400                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProFlu+ Assay
HOLOGIC, INC.                     510(k) NO: K153219(Special)
ATTN: RON  DOMINGO                PHONE NO : 858 4108167 
10210 GENETIC CENTER DRIVE        SE DECISION MADE: 20-NOV-15
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    


                    TOTAL 510(k)s THIS PERIOD   228                                     
                    TOTAL WITH SUMMARIES        212                                     
                    TOTAL WITH STATEMENTS        16
                                      

Page Last Updated: 12/07/2015
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