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U.S. Department of Health and Human Services

Medical Devices

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February 2013 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD February 2013


DEVICE: DEKA SMARTXIDE AND DELIVERY ACCESSORIES
EL.EN. ELECTRONIC ENGINEERING SPA 510(k) NO: K113504(TRADITIONAL)
ATTN: PAOLO  PERUZZI              PHONE NO : 390 558 826407
17 VIA BALDANZESE                 SE DECISION MADE: 01-FEB-13
CALENZANO    IT 50041             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MILAGRO ADVANCE INTERFERENCE SCREW
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K123362(TRADITIONAL)
ATTN: YAYOI  FUJIMAKI             PHONE NO : 508 828 3541   
325 PARAMOUNT DR.                 SE DECISION MADE: 01-FEB-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INCORIS TZI
SIRONA DENTAL SYSTEMS GMBH        510(k) NO: K123545(TRADITIONAL)
ATTN: FRITZ  KOLLE                PHONE NO : 496 251163 294
FABRIKSTRASSE 31                  SE DECISION MADE: 01-FEB-13
BENSHEIM    GM D-64625            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUVASIVE LONG LATERAL SPINAL SYSTEM
NUVASIVE, INC.                    510(k) NO: K122081(SPECIAL)
ATTN: ELIAS  KETCHUM              PHONE NO : 858 320 4588   
7475 LUSK BLVD                    SE DECISION MADE: 01-FEB-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNGO, BREAST CARE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123420(TRADITIONAL)
ATTN: PATRICIA D JONES            PHONE NO : 610 448 3536   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 01-FEB-13
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARKRAY AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM
ARKRAY, INC.                      510(k) NO: K121456(TRADITIONAL)
ATTN: ADAM  ETTL                  PHONE NO : 952 646 3142   
5182 WEST 76TH STREET             SE DECISION MADE: 01-FEB-13
EDINA MN 55439                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR
ASSURGUARD SDN. BHD.              510(k) NO: K123757(TRADITIONAL)
ATTN: LIM H GUAN                  PHONE NO : 603 329710 20
82F, JALAN PULASAN KLANG          SE DECISION MADE: 01-FEB-13
SELANGOR DARUL EHSAN    MY 41000  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVEL FIT AND FILL STEM
HOWMEDICA OSTEONICS CORP          510(k) NO: K122853(TRADITIONAL)
ATTN: VALERIE  GIAMBANCO          PHONE NO : 201 831 6275   
325 CORPORATE DR.                 SE DECISION MADE: 01-FEB-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASYSPINE SYSTEM
LDR SPINE USA INC.                510(k) NO: K123134(TRADITIONAL)
ATTN: MARITZA  ELIAS              PHONE NO : 512 344 3371   
13785 RESEARCH BOULEVARD SUITE 200SE DECISION MADE: 01-FEB-13
AUSTIN TX 78750                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARCHITECT TOTAL BILIRUBIN
ABBOTT LABORATORIES               510(k) NO: K121985(TRADITIONAL)
ATTN: LINDA  MORRIS               PHONE NO : 972 518 6711   
1921 HURD DRIVE                   SE DECISION MADE: 01-FEB-13
IRVING TX 75038                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B
ROCKET MEDICAL PLC                510(k) NO: K123033(TRADITIONAL)
ATTN: TRACY  CHARLTON             PHONE NO : 004 419 14194488
FACTORIES 2& 4, SEDLING RD WEAR INSE DECISION MADE: 01-FEB-13
WASHINGTON, TYNE & WEAR    UK NE38510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANTERIOR CERVICAL PLATE SYSTEM
WEIGAO ORTHOPAEDIC DEVICE CO., LTD510(k) NO: K123578(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
PO BOX 237-023                    SE DECISION MADE: 01-FEB-13
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLANMED VERITY
PLANMED OY                        510(k) NO: K121418(TRADITIONAL)
ATTN: LARS  MORING                PHONE NO : 358 207 795300
Sorvaajankatu 7                   SE DECISION MADE: 01-FEB-13
Helsinki    FI 00880              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIOLASE 10S
BIOLASE TECHNOLOGY, INC.          510(k) NO: K121327(TRADITIONAL)
ATTN: ROBERT  YANG                PHONE NO : 949 361 1200   
4 CROMWELL                        SE DECISION MADE: 01-FEB-13
IRVINE CA 92618 1816              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ICS IMPULSE
GN OTOMETRICS                     510(k) NO: K122550(TRADITIONAL)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 01-FEB-13
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E-CUBE 15
ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K123610(TRADITIONAL)
ATTN: DONGHWAN  KIM               PHONE NO : 82 70 74652068
1, 6 AND 7FL, VERDI TOWER 72, DIGISE DECISION MADE: 01-FEB-13
SEOUL    KS 152-848               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INVIVO  DENTAL
ANATOMAGE, INC                    510(k) NO: K123519(TRADITIONAL)
ATTN: MIKE  MENDEZ                PHONE NO : 408 885 1474   
111N. MARKET ST, STE 800          SE DECISION MADE: 01-FEB-13
SAN JOSE CA 95113                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DORNIER MEDILAS H30 SOLVO
DORNIER MEDTECH AMERICA, INC.     510(k) NO: K122159(SPECIAL)
ATTN: JOHN  HOFFER                PHONE NO : 770 514 6163   
1155 ROBERTS BLVD.                SE DECISION MADE: 01-FEB-13
KENNESAW GA 30144                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE
SMITHS MEDICAL ASD, INC.          510(k) NO: K111275(TRADITIONAL)
ATTN: JULIE  TAPPER               PHONE NO : 651 628 7018   
1265 GREY FOX ROAD                SE DECISION MADE: 01-FEB-13
ARDEN HILLS MN 55112              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EPIEN ROOT CANAL CLEANSER
EPIEN MEDICAL, INC.               510(k) NO: K123538(TRADITIONAL)
ATTN: JEFFREY K SHAPIRO           PHONE NO : 202 737 9633   
700 THIRTEENTH ST. NW STUITE 200  SE DECISION MADE: 01-FEB-13
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICRODOSE SI
PHILIPS DIGITAL MAMMOGRAPHY SWEDEN510(k) NO: K123995(SPECIAL)
ATTN: GUSTAV  LINS                PHONE NO : 468 623 5200
SMIDESVAGEN 5                     SE DECISION MADE: 01-FEB-13
SOLNA    SW SE-171 41             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIVIX-S WIRELESS
VIEWORKS CO., LTD.                510(k) NO: K122865(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 869 3080   
951 STARBUCK ST UNIT J            SE DECISION MADE: 01-FEB-13
FULLERTON CA 92833                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM
CIANNA MEDICAL                    510(k) NO: K120804(TRADITIONAL)
ATTN: GARY  MOCNIK                PHONE NO : 949 360 0059   
6 JOURNEY, SUITE 125              SE DECISION MADE: 04-FEB-13
ALISO VIEJO CA 92656              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WRIST PULSE OXIMETER
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K122046(TRADITIONAL)
ATTN: LEI  CHEN                   PHONE NO : 861 088 790480
NO. 9 SHUANGYUAN RD. SHIJINGSHAN DSE DECISION MADE: 04-FEB-13
BEIJING    CH 100041              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOMATED ENDOSCOPE LEAK TESTER
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K123704(TRADITIONAL)
ATTN: DAPHNEY  GERMAIN-KOLAWOLE   PHONE NO : 484 896 5691   
REGULATORY AFFAIRS & QUALITY ASSURSE DECISION MADE: 04-FEB-13
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VARI-PASS VARIABLE LENGTH ACCESS SHEATH
OLYMPUS SURGICAL TECHNOLOGIES AMER510(k) NO: K123170(SPECIAL)
ATTN: DEANA  BOUSHELL             PHONE NO : 508 804 2752   
136 TURNPIKE ROAD                 SE DECISION MADE: 04-FEB-13
SOUTHBOROUGH MA 01772             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: A-GRIX TE RESORABLE BONE VOID FILLER
AG DIGITAL TECHNOLOGY CORP.       510(k) NO: K121453(TRADITIONAL)
ATTN: JENNIFER  REICH             PHONE NO : 928 853 6340   
2904 N. BOLDT DRIVE               SE DECISION MADE: 05-FEB-13
FLAGSTAFF AZ 86001                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)
NANTONG BIOTECHNOLOGY CO., LTD.   510(k) NO: K123050(TRADITIONAL)
ATTN: JOE  XIA                    PHONE NO : 301 250 0831   
12828 DOE LANE                    SE DECISION MADE: 05-FEB-13
GAITHERSBURG MD 20878             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD
COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K122781(TRADITIONAL)
ATTN: MARY  MELLOWS               PHONE NO : 203 492 5284   
60 Middletown Ave                 SE DECISION MADE: 05-FEB-13
North Haven CT 06473              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISCOSTAT CLEAR
ULTRADENT PRODUCTS, INC.          510(k) NO: K123215(TRADITIONAL)
ATTN: KAREN  KAKUNES              PHONE NO : 801 553 4366   
505 WEST 10200 SOUTH              SE DECISION MADE: 05-FEB-13
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFESPAN EPTFE VASCULAR GRAFT
LEMAITRE VASCULAR, INC.           510(k) NO: K130016(SPECIAL)
ATTN: XIANG  ZHANG                PHONE NO : 781 425 1729   
63 2ND AVENUE                     SE DECISION MADE: 05-FEB-13
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR
PARCUS MEDICAL, LLC               510(k) NO: K122805(TRADITIONAL)
ATTN: PAUL  VAGTS                 PHONE NO : 920 746 2972   
839 SOUTH NEENAH AVE.             SE DECISION MADE: 05-FEB-13
STURGEON BAY WI 54235             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUGMENT AND SCREW, PSA TYPE
UNITED ORTHOPEDIC CORP.           510(k) NO: K122183(TRADITIONAL)
ATTN: FANG-YUAN  HO               PHONE NO : 886 357 73351X2212
57 PARK AVE. 2, SCIENCE PARK      SE DECISION MADE: 05-FEB-13
HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GIRAFFE AND PANDA WARMERS
OHMEDA MEDICAL                    510(k) NO: K123309(TRADITIONAL)
ATTN: AGATA  ANTHONY              PHONE NO : 410 888 5200   
8880 GORMAN RD.                   SE DECISION MADE: 05-FEB-13
LAUREL MD 20723                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL THERMOMTER
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K122520(TRADITIONAL)
ATTN: PINJUNG  CHEN               PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD WUGU DISE DECISION MADE: 05-FEB-13
NEW TAIPEI CITY    TW 24888       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PASS LP SPINAL SYSTEM
MEDICREA INTERNATIONAL            510(k) NO: K123138(TRADITIONAL)
ATTN: LAURE  AVIRON-VIOLET        PHONE NO : 334 72 018787
14 PORTE DU GRAND LYON            SE DECISION MADE: 05-FEB-13
NEYRON    FR 01700                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE
ETHICON, INC.                     510(k) NO: K123114(TRADITIONAL)
ATTN: SUSAN  LIN                  PHONE NO : 908 218 2256   
ROUTE 22 WEST P.O. BOX 151        SE DECISION MADE: 05-FEB-13
SOMERVILLE NJ 08876 0151          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDEASCREEN
CARDEA ASSOCIATES INC             510(k) NO: K123217(TRADITIONAL)
ATTN: DAVID M HADLEY              PHONE NO : 800 855 0760   
137220 220TH PLACE NE             SE DECISION MADE: 05-FEB-13
WOODINVILLE WA 98077              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PROFEMUR Z CLASSIC STEMS
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K123434(SPECIAL)
ATTN: DAVID  FITCH                PHONE NO : 901 290 5945   
5677 AIRLINE RD.                  SE DECISION MADE: 05-FEB-13
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRC-NW300 NON-MYDRIATIC RETINAL CAMERA
TOPCON MEDICAL SYSTEMS, INC.      510(k) NO: K123460(TRADITIONAL)
ATTN: MICHAEL  GUSEL              PHONE NO : 201 599 5553   
111 Bauer Dr                      SE DECISION MADE: 06-FEB-13
Oakland NJ 07436                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAAS INTRAVASCULAR
PIE MEDICAL IMAGING B.V.          510(k) NO: K123970(TRADITIONAL)
ATTN: FLORIE  DANIELS             PHONE NO : 31 433281 328
BECANUSSTRAAT 13 D                SE DECISION MADE: 06-FEB-13
MAASTRICHT    NL 6216 BX          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISUAL-ICE CRYOABLATION SYSTEM
GALIL MEDICAL INC.                510(k) NO: K123865(SPECIAL)
ATTN: AMY  MCKINNEY               PHONE NO : 651 287 5096   
6518 TAMARIND SKY LN              SE DECISION MADE: 06-FEB-13
FULSHEAR TX 77441                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APLIO 500/400/300 V3.0
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K123992(SPECIAL)
ATTN: CHARLEMAGNE  CHUA           PHONE NO : 714 669 7896   
2441 MICHELLE DRIVE               SE DECISION MADE: 06-FEB-13
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASAHI REXEED-SX/LX SERIES DIALYZER
ASAHI KASEI MEDICAL CO., LTD.     510(k) NO: K121409(TRADITIONAL)
ATTN: PATSY  TRISLER              PHONE NO : 301 652 5344   
154 MAIN STREET, STE 2            SE DECISION MADE: 06-FEB-13
CHARLESTOWN NH 03603              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GE DATEX-OHMEDA AVANCE CS2
DATEX-OHMEDA, INC.                510(k) NO: K123125(SPECIAL)
ATTN: JAMES P RASKOB              PHONE NO : 608 221 1551   
3030 OHMEDA DRIVE PO BOX 7550     SE DECISION MADE: 06-FEB-13
MADISON WI 53707 7550             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP
BECTON, DICKINSON AND COMPANY     510(k) NO: K122718(TRADITIONAL)
ATTN: GREGORY P PAYNE             PHONE NO : 858 795 7890   
10865 ROAD TO THE CURE, SUITE 200 SE DECISION MADE: 06-FEB-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHEATHES STERILE ULTRASOUND GEL
SHEATHING TECHNOLOGIES, INC.      510(k) NO: K130041(TRADITIONAL)
ATTN: JENNIFER  DOWNING           PHONE NO : 408 782 2720   
18431 TECHNOLOGY DR.              SE DECISION MADE: 06-FEB-13
MORGAN HILL CA 95037              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EEGER4 MODEL 4.3
EEG SOFTWARE LLC                  510(k) NO: K122879(TRADITIONAL)
ATTN: HOWARD  LIGHTSTONE          PHONE NO : 818 886 2585   
17625 MAYALL STREET               SE DECISION MADE: 06-FEB-13
NORTHRIDGE CA 91325               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHERPA PAK CARDIAC TRANSPORT SYSTEM
PARAGONIX TECHNOLOGIES, INC.      510(k) NO: K123326(TRADITIONAL)
ATTN: LEO  BASTA                  PHONE NO : 617 834 9866   
755 WESTMINISTER STREET UNIT 120  SE DECISION MADE: 06-FEB-13
PROVIDENCE MA 02903               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
OXFORD PERFORMANCE MATERIALS      510(k) NO: K121818(TRADITIONAL)
ATTN: LEIGH  AYRES                PHONE NO : 860 698 9300   
30 S SATELLITE ROAD               SE DECISION MADE: 07-FEB-13
SOUTH WINDSOR CT 06074            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION
LIFESCAN, INC.                    510(k) NO: K120558(TRADITIONAL)
ATTN: ANDREA  TASKER              PHONE NO : 610 651 7282   
200 LAWRENCE DRIVE MAILSTOP C-2-2 SE DECISION MADE: 07-FEB-13
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M2 WRIST MRI SYSTEM
ASPECT IMAGING LTD                510(k) NO: K120701(TRADITIONAL)
ATTN: AHAVA  STEIN                PHONE NO : 972 976 70002
20 HATA'AS ST (OPB 124)           SE DECISION MADE: 07-FEB-13
KFAR SABA    IS 44425             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM
MAXIM SURGICAL                    510(k) NO: K123206(TRADITIONAL)
ATTN: CHRIS  REEG                 PHONE NO : 214 564 1350   
1565 NORTH CENTRAL EXPRESSWAY SUITSE DECISION MADE: 07-FEB-13
RICHARDSON TX 75080               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE
BECTON DICKINSON & CO.            510(k) NO: K121050(TRADITIONAL)
ATTN: JOHN  ROBERTS               PHONE NO : 201 847 5473   
1 BECTON DRIVE                    SE DECISION MADE: 07-FEB-13
FRANKLIN LAKES NJ 07417           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOXCUP DRUG SCREEN CUP
BRANAN MEDICAL CORP.              510(k) NO: K122633(TRADITIONAL)
ATTN: OLIVIA  CHAN                PHONE NO : 949 598 7166   
140 Technology Dr Ste 400         SE DECISION MADE: 07-FEB-13
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RELIANCE SPINAL SCREW SYSTEM
RELIANCE MEDICAL SYSTEMS, LLC     510(k) NO: K123521(SPECIAL)
ATTN: BRET M BERRY                PHONE NO : 801 295 3280   
P.O. BOX 1693                     SE DECISION MADE: 07-FEB-13
BOUNTIFUL UT 84010                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XIPHOS
DIFUSION TECHNOLOGIES             510(k) NO: K123969(TRADITIONAL)
ATTN: KAREN E WARDEN, PHD         PHONE NO : 440 729 8457   
PO BOX 566                        SE DECISION MADE: 07-FEB-13
CHESTERLAND OH 44026 2141         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM
SPECTRUM SPINE, LLC               510(k) NO: K122822(TRADITIONAL)
ATTN: MEREDITH  MAY               PHONE NO : 719 337 7579   
4628 NORTHPARK DRIVE              SE DECISION MADE: 07-FEB-13
COLORADO SPRINGS CO 80918         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINEOLOGY SPINOUS PROCESS PLATE
SPINEOLOGY, INC.                  510(k) NO: K123232(TRADITIONAL)
ATTN: BRYAN  BECKER               PHONE NO : 651 256 8534   
7800 3RD ST N., SUITE 600         SE DECISION MADE: 07-FEB-13
ST. PAUL MN 55128                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN
AIMAGO SA                         510(k) NO: K123216(TRADITIONAL)
ATTN: MARC  ANDRE                 PHONE NO : 41 21 5105561
Parc Scientifique EPFL D 4TH FLOORSE DECISION MADE: 07-FEB-13
Lausanne    SZ 1015               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
ST. JUDE MEDICAL                  510(k) NO: K122587(SPECIAL)
ATTN: HARLAN  JONES               PHONE NO : 651 756 3429   
14901 DEVEAU PL.                  SE DECISION MADE: 07-FEB-13
MINNETONKA MN 55345 2126          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
SELECTIVEMED COMPONENTS INC.      510(k) NO: K120922(ABBREVIATED)
ATTN: DANIEL  KAMM                PHONE NO : 239 234 1735   
8870 RAVELLO CT                   SE DECISION MADE: 07-FEB-13
NAPLES FL 34114                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENASIS SCANVIEW SYSTEM
APPLIED SPECTRAL IMAGING, LTD.    510(k) NO: K122554(TRADITIONAL)
ATTN: ILAN  SHARON                PHONE NO : 972 52 8704904
A-109 NETO- GOLF                  SE DECISION MADE: 07-FEB-13
CAESAREA    IS 30889              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESPIN
NLT SPINE LTD                     510(k) NO: K130057(SPECIAL)
ATTN: JOHN J SMITH                PHONE NO : 202 637 3638   
555 THIRTEENTH STREET NW          SE DECISION MADE: 07-FEB-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPRESSYN STAPLE
DALLEN MEDICAL, INC.              510(k) NO: K122871(TRADITIONAL)
ATTN: AL  MEMMOLO                 PHONE NO : 949 218 0030   
1046 Calle Recodo Ste G           SE DECISION MADE: 07-FEB-13
San Clemente CA 92673             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM
CILAG GMBH INTERNATIONAL          510(k) NO: K120708(TRADITIONAL)
ATTN: NADINE  NASR                PHONE NO : 408 956 4079   
1000 GIBRALTAR DRIVE              SE DECISION MADE: 07-FEB-13
MILPITAS CA 95035                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE
PUYANG LINSHI HEALTH CO., LTD     510(k) NO: K123488(TRADITIONAL)
ATTN: LAURA  WENG                 PHONE NO : 626 581 3030   
17800 CASTLETON ST. SUITE 328     SE DECISION MADE: 08-FEB-13
CITY OF INDUSTRY CA 91748         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORONIS FUSION 6MP
BARCO N.V.                        510(k) NO: K130103(SPECIAL)
ATTN: LIEVEN  DE WANDEL           PHONE NO : 32 562332 11
PRESIDENT KENNEDYPARK 35          SE DECISION MADE: 08-FEB-13
KORTRIJK    BE 8500               510(k) STATEMENT

DEVICE: ALEXIS O WOUND PROTECTOR/RETRACTOR
APPLIED MEDICAL RESOURCES CORP.   510(k) NO: K113268(TRADITIONAL)
ATTN: FRANS  VANDENBROEK          PHONE NO : 949 713 8369   
22872 AVENIDA EMPRESA             SE DECISION MADE: 08-FEB-13
RANCHO SANTA MARGARITA CA 92688   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIAGNOSTIC ULTRASOUND SYSTEM
EDAN INSTRUMENTS, INC.            510(k) NO: K123249(TRADITIONAL)
ATTN: RANDY  JIANG                PHONE NO : 860 755268 56469
EQUIPMENTS PARK, NANHAI RD 1019 NOSE DECISION MADE: 08-FEB-13
SHENZHEN    CH 518067             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MYOSURE INTRUMENT TRAY
HOLOGIC, INC.                     510(k) NO: K121280(TRADITIONAL)
ATTN: DANIEL F PHELAN             PHONE NO : 805 262 8851   
250 CAMPUS DRIVE                  SE DECISION MADE: 08-FEB-13
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM
ALBAHEALTH, L.L.C.                510(k) NO: K123308(TRADITIONAL)
ATTN: PATRICK  FRANK              PHONE NO : 865 354 0410   
425 NORTH GATEWAY AVE.            SE DECISION MADE: 08-FEB-13
ROCKWOOD TN 37854                 510(k) STATEMENT

DEVICE: VICTUS FEMTOSECOND LASER PLATFORM
TECHNOLAS PERFECT VISION GMBH     510(k) NO: K122386(TRADITIONAL)
ATTN: BETTY M JOHNSON             PHONE NO : 714 273 8254   
PO BOX 17190                      SE DECISION MADE: 08-FEB-13
ANAHEIM CA 92817 7190             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNI-GOLD CRYPTOSPORIDIUM
TRINITY BIOTECH                   510(k) NO: K121565(TRADITIONAL)
ATTN: LUPE  KAGAN                 PHONE NO : 760 929 0500   
5919 FARNSWORTH CT.               SE DECISION MADE: 08-FEB-13
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADENOVIRUS R-GENE US
ARGENE SA                         510(k) NO: K121942(TRADITIONAL)
ATTN: ERIC  BRISSON               PHONE NO : 335 616 96100
PARC TECHNOLOGIQUE DELTA SUD      SE DECISION MADE: 08-FEB-13
VARILHES    FR 09120              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR
PSYCHEMEDICS CORP.                510(k) NO: K123799(TRADITIONAL)
ATTN: VIRGINIA  HILL              PHONE NO : 310 216 7776   
5832 UPLANDER WAY                 SE DECISION MADE: 08-FEB-13
CULVER CITY CA 90230              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI
TOSOH BIOSCIENCE, INC.            510(k) NO: K123131(TRADITIONAL)
ATTN: ROBERT L WICK               PHONE NO : 650 636 8117   
6000 SHORELINE COURT SUITE 101    SE DECISION MADE: 08-FEB-13
SOUTH SAN FRANCISCO CA 94080      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGERY REHEARSAL PLATFORM
SURGICAL THEATER, LLC             510(k) NO: K123023(TRADITIONAL)
ATTN: MORDECHAI  AVISAR           PHONE NO : 216 496 7884   
151 INNOVATION DR.                SE DECISION MADE: 08-FEB-13
ELYRIA OH 44141                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROFEMUR TL CLASSIC HIP STEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K123688(SPECIAL)
ATTN: YUAN  LI                    PHONE NO : 901 867 4146   
5677 AIRLINE RD.                  SE DECISION MADE: 08-FEB-13
ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMPACT DIGITAL BLOOD PRESSURE MONITOR
THERMOR LTD.                      510(k) NO: K122810(TRADITIONAL)
ATTN: MARK  BEATON                PHONE NO : 800 387 8520
16975 LESLIE ST.                  SE DECISION MADE: 08-FEB-13
NEWMARKET    CA L3Y 9A1           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 4MP COLOR LCD MONITOR, RADIFORCE RX 440
EIZO NANAO CORPORATION            510(k) NO: K130070(TRADITIONAL)
ATTN: HIROAKI  HASHIMOTO          PHONE NO : 817 627424 68
153 SHIMOKASHIWANO                SE DECISION MADE: 08-FEB-13
HAKUSAN    JA 924-8566            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTIMA CT520
GE HANGWEI MEDICAL SYSTEMS CO., LT510(k) NO: K123596(TRADITIONAL)
ATTN: HELEN  PENG                 PHONE NO : 262 424 8222
NO. 2  N. YONGCHANG STREET BEIJINGSE DECISION MADE: 08-FEB-13
BEIJING    CH 100176              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE
ORMCO CORP.                       510(k) NO: K122065(TRADITIONAL)
ATTN: WENDY  GARMAN               PHONE NO : 714 516 7602   
1717 WEST COLLINS AVENUE          SE DECISION MADE: 08-FEB-13
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS
HEINZ KURZ GMBH MEDIZINTECHNIK    510(k) NO: K112616(TRADITIONAL)
ATTN: KRISTINA  BITZER            PHONE NO : 497 072 917939
AMSTEL 320-1                      SE DECISION MADE: 08-FEB-13
AMSTERDAM    NL 1017 AP           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: J-SCOPE SYSTEM
MYELOTEC                          510(k) NO: K122411(ABBREVIATED)
ATTN: BLIX  WINSTON               PHONE NO : 304 607 9185   
2600 MULLINIX MILL ROAD           SE DECISION MADE: 11-FEB-13
MT. AIRY MD 21771                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLEA
CONVERGENT DENTAL, INC            510(k) NO: K123494(TRADITIONAL)
ATTN: CARRIE  HETRICK             PHONE NO : 512 327 9997   
611 WEST 5TH STREET THIRD FLOOR   SE DECISION MADE: 11-FEB-13
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FILMARRAY RESPIRATORY PANEL (RP)
BIOFIRE DIAGNOSTICS, INC.         510(k) NO: K123620(TRADITIONAL)
ATTN: BETH  LINGENFELTER          PHONE NO : 801 736 6354   
390 WAKARA WAY                    SE DECISION MADE: 11-FEB-13
SALT LAKE CITY UT 84108           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
CERAGEM MEDISYS INC.              510(k) NO: K102751(TRADITIONAL)
ATTN: GRACE  KIM                  PHONE NO : 213 480 7105   
3699 WILSHIRE BLVD., STE 930      SE DECISION MADE: 11-FEB-13
LOS ANGELES CA 90010              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IPL THERAPY SYSTEM
BEIJING SINCOHEREN S&T DEVELOPMENT510(k) NO: K123435(TRADITIONAL)
ATTN: MIKE  GU                    PHONE NO : 86 206 2321333
7TH FLOOR 982 CONGYUN ROAD, BAIYUNSE DECISION MADE: 11-FEB-13
GUANGZHOU, GUANGDONG    CH 510420 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK
3M COMPANY                        510(k) NO: K121069(TRADITIONAL)
ATTN: JIZHONG  JIN                PHONE NO : 651 733 6655   
3M CENTER, BLDG. 275-5W-06        SE DECISION MADE: 11-FEB-13
ST. PAUL MN 55144 1000            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)
WORLDMED MANUFACTURING SDN. BHD.  510(k) NO: K123116(TRADITIONAL)
ATTN: OOI LOON  SENG              PHONE NO : 605 82 95555
Lot 18873, Jalan Perusahaan3, KamuSE DECISION MADE: 11-FEB-13
Kamunting    MY 34600             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BABYLANCE HEEL INCISION DEVICE
MEDIPURPOSE PTE. LTD.             510(k) NO: K130132(SPECIAL)
ATTN: JULIE  STEPHENS             PHONE NO : 678 513 0693   
111 LAUREL RIDGE DRIVE            SE DECISION MADE: 11-FEB-13
ALPHARETTA GA 30004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHONAK TINNITUS BALANCE
PHONAK LLC                        510(k) NO: K123450(ABBREVIATED)
ATTN: LAURA  ELLMAN               PHONE NO : 630 821 5000   
4520 WEAVER PARKWAY               SE DECISION MADE: 11-FEB-13
WARRENVILLE IL 60555              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS
CORIN USA                         510(k) NO: K123705(TRADITIONAL)
ATTN: DIANA L MARTONE             PHONE NO : 813 977 4469   
5670 W. CYPRESS ST. SUITE C       SE DECISION MADE: 12-FEB-13
TAMPA FL 33607                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
ROCHE DIAGNOSTICS                 510(k) NO: K113614(TRADITIONAL)
ATTN: MICHAEL  FLIS               PHONE NO : 317 521 2110   
9115 HAGUE ROAD                   SE DECISION MADE: 12-FEB-13
INDIANAPOLIS IN 46250 0457        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
TELEFLEX MEDICAL, INC.            510(k) NO: K130043(SPECIAL)
ATTN: NATALIE  SMITH              PHONE NO : 919 433 8049   
2917 WECK DR.                     SE DECISION MADE: 12-FEB-13
RESEARCH TRIANGLE PARK NC 27709   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FORYOU NPWT DEVICE
FORYOU MEDICAL ELECTRONICS CO, LTD510(k) NO: K113236(TRADITIONAL)
ATTN: SCOTT  WRIGHT               PHONE NO : 724 996 6206   
3919 WILLIAM PENN HIGHWAY, SUITE 2SE DECISION MADE: 12-FEB-13
MURRYSVILLE PA 15668              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123938(TRADITIONAL)
ATTN: NADIA  SOOKDEO              PHONE NO : 610 448 4918   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 12-FEB-13
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STA COMPACT MAX
DIAGNOSTICA STAGO, INCORPORATED   510(k) NO: K130090(SPECIAL)
ATTN: CARLO  D'ALESSANDRO         PHONE NO : 390 657 82665
PIAZZA ALBANIA, 10                SE DECISION MADE: 12-FEB-13
ROME    IT 00153                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEW STETIC ARTIFICIAL TEETH
NEW STETIC                        510(k) NO: K122925(TRADITIONAL)
ATTN: JOHN  OBRIEN                PHONE NO : 813 645 2855   
445 APOLLO BEACH BLVD             SE DECISION MADE: 12-FEB-13
APOLLO BEACH FL 33572             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
DAKO NORTH AMERICA, INC.          510(k) NO: K120663(TRADITIONAL)
ATTN: XIAOLEI  XU                 PHONE NO : 805 566 3013   
6392 VIA REAL                     SE DECISION MADE: 12-FEB-13
CARPINTERIA CA 93013              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GIBRALT  OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES
EXACTECH, INC.                    510(k) NO: K121877(TRADITIONAL)
ATTN: VLADISLAVA  ZAITSEVA        PHONE NO : 352 377 1140   
2320 N.W. 66TH CT.                SE DECISION MADE: 12-FEB-13
GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER
EV3 INC                           510(k) NO: K123544(TRADITIONAL)
ATTN: LAURA J LIND                PHONE NO : 763 398 7000   
3033 CAMPUS DRIVE                 SE DECISION MADE: 12-FEB-13
PLYMOUTH MN 55441 2651            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED
SORIN GROUP ITALIA S.R.L.         510(k) NO: K130209(SPECIAL)
ATTN: SCOTT  LIGHT                PHONE NO : 303 467 6313   
14401 W. 65TH WAY                 SE DECISION MADE: 12-FEB-13
ARVADA CO 80004                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANSFERRIN KIT FOR USE ON THE SPAPLUS
THE BINDING SITE GROUP LTD        510(k) NO: K120236(TRADITIONAL)
ATTN: JILL  CONSTANTINE           PHONE NO : 440 121 4569500
8 CALTHORPE ROAD EDGBASTON        SE DECISION MADE: 13-FEB-13
BIRMINGHAM, WEST MIDLANDS    UK B1510(k) STATEMENT

DEVICE: DOSE TRACKING SYSTEM MODEL XIDF-DTS801
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K123097(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 Michelle Dr                  SE DECISION MADE: 13-FEB-13
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS
K2M, INC.                         510(k) NO: K123412(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR., S.E., SUITE F1    SE DECISION MADE: 13-FEB-13
Leesburg VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRASOUND SCANNER FLEX FOCUS
B-K MEDICAL APS                   510(k) NO: K123254(TRADITIONAL)
ATTN: RANDI  HAUERBERG            PHONE NO : 011 45 44528100
MILEPARKEN 34                     SE DECISION MADE: 13-FEB-13
HERLEV    DA DK-2730              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
MEDTRONIC NEUROSURGERY            510(k) NO: K123524(TRADITIONAL)
ATTN: DONOVAN  MAY                PHONE NO : 805 571 8578   
125 CREMONA DR.                   SE DECISION MADE: 13-FEB-13
GOLETA CA 93117                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRA PROXIMAL HUMERAL PLATE SYSTEM
ASCENSION ORTHOPEDICS, INC.       510(k) NO: K121826(TRADITIONAL)
ATTN: SUSAN  WALTON               PHONE NO : 512 836 5001   
8700 CAMERON RD                   SE DECISION MADE: 13-FEB-13
AUSTIN TX 78754                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: A200 KNEE SYSTEM
RENOVIS SURGICAL TECHNOLOGIES, LLC510(k) NO: K120038(TRADITIONAL)
ATTN: KEVIN A THOMAS              PHONE NO : 858 792 1235   
11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 14-FEB-13
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM
HUIZHOU FORYOU MEDICAL DEVICES CO,510(k) NO: K120181(TRADITIONAL)
ATTN: CHENGYU  SHEN               PHONE NO : 608 217 9358   
5 CAREY STREET                    SE DECISION MADE: 14-FEB-13
PENNINGTON NJ 08534               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MALE LATEX CONDOM
NULATEX SDN. BHD.                 510(k) NO: K121241(ABBREVIATED)
ATTN: TEO AI  SIANG               PHONE NO : 607 777 1801
LOT 1870, 4TH MLE MENGKIBOL       SE DECISION MADE: 14-FEB-13
KLUANG    MY 86000                510(k) STATEMENT

DEVICE: ACON BUP ONE STEP BUPRENORPHINE TEST STRIP
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K130055(TRADITIONAL)
ATTN: JOE  SHIA                   PHONE NO : 240 505 7880   
504 EAST DIAMOND AVE. SUITE F     SE DECISION MADE: 14-FEB-13
GAITHERSBURG MD 20878             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
HMD BIOMEDICAL, INC.              510(k) NO: K121433(TRADITIONAL)
ATTN: JESSICA  TUNG               PHONE NO : 886 360170 00
#181 MINSHENG STREET              SE DECISION MADE: 14-FEB-13
XINPU TOWNSHIP, HSINCHU COUNTY    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VASHE WOUND THERAPY SOLUTION
PURICORE, INC.                    510(k) NO: K123072(TRADITIONAL)
ATTN: ART  MORSE                  PHONE NO : 484 321 2728   
508 LAPP ROAD                     SE DECISION MADE: 14-FEB-13
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES
GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K120675(TRADITIONAL)
ATTN: PATRICK  CHOW               PHONE NO : 008 522 8516278
ZHU KENG INDUSTRIAL ZONE PING SHANSE DECISION MADE: 14-FEB-13
SHENSHEN, GUANG DONG    CH 518118 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK
BIONOSTICS, INC.                  510(k) NO: K123851(TRADITIONAL)
ATTN: RANDY  BYRD                 PHONE NO : 978 862 1830   
7 JACKSON RD.                     SE DECISION MADE: 14-FEB-13
DEVENS MA 01434                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT
ARTHROCARE CORPORATION            510(k) NO: K123240(TRADITIONAL)
ATTN: CHERYL  FREDERICK           PHONE NO : 512 358 5751   
7000 W William Cannon Dr          SE DECISION MADE: 14-FEB-13
Austin TX 78735                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ILLICO MIS POSTERIOR FIXATION SYSTEM
ALPHATEC SPINE, INC.              510(k) NO: K123623(TRADITIONAL)
ATTN: NADINE  SMITH               PHONE NO : 760 494 6717   
5818 EL CAMINO REAL               SE DECISION MADE: 14-FEB-13
CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: A5 ANESTHESIA DELIVERY SYSTEM
DATASCOPE CORP., PATIENT MONITORIN510(k) NO: K123211(ABBREVIATED)
ATTN: RUSSELL  OLSEN              PHONE NO : 201 995 8391   
800 MACARTHUR BLVD.               SE DECISION MADE: 14-FEB-13
MAHWAH NJ 07430 0619              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFESTYLES NATURAL PERSONAL LUBRICANT
ANSELL HEALTHCARE PRODUCTS, LLC   510(k) NO: K122054(TRADITIONAL)
ATTN: DONNA  DIGANGI              PHONE NO : 805 541 3344   
4 LOS VERDES DRIVE                SE DECISION MADE: 14-FEB-13
SAN LUIS OBISPO CA 93401          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ECG CHECK
CARDIAC DESIGNS, LLC              510(k) NO: K122184(TRADITIONAL)
ATTN: KARIM  MARROUCHE            PHONE NO : 512 852 2453   
3293 NIBLICK DRIVE                SE DECISION MADE: 14-FEB-13
PARK CITY UT 84098                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P
HOWMEDICA OSTEONICS CORP          510(k) NO: K123166(TRADITIONAL)
ATTN: AUDREY  WITKO               PHONE NO : 201 831 6717   
325 CORPORATE DR.                 SE DECISION MADE: 14-FEB-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISO-GARD CLEARAIR MASK
TELEFLEX MEDICAL, INC.            510(k) NO: K123176(TRADITIONAL)
ATTN: ANGELA  BOUSE               PHONE NO : 919 433 4904   
2917 WECK DR. PO BOX 12600        SE DECISION MADE: 14-FEB-13
RESEARCH TRIANGLE PARK NC 27709   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EQUAFLOW MULTIVALVE INFUSION CATHETER
COOK INCORPORATED                 510(k) NO: K123235(TRADITIONAL)
ATTN: AMBER  BROWN                PHONE NO : 812 339 2235   
750 DANIELS WAY                   SE DECISION MADE: 14-FEB-13
BLOOMINGTON IN 47404              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITRO MOLAR
DFL INDUSTRIA E COMERCIO S.A.     510(k) NO: K123826(TRADITIONAL)
ATTN: TARA  CONRAD                PHONE NO : 305 206 6777   
18851 NE 29TH AVE 720             SE DECISION MADE: 14-FEB-13
AVENTURE FL 33180                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONOJECT 12ML SYRINGE
NIPRO MEDICAL CORPORATION         510(k) NO: K130049(SPECIAL)
ATTN: JESSICA  OSWALD-MCLEOD      PHONE NO : 305 599 7174   
3150 N.W. 107TH AVE.              SE DECISION MADE: 14-FEB-13
MIAMI FL 33172                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
EXACT MEDICAL MANUFACTURING, INC  510(k) NO: K121919(TRADITIONAL)
ATTN: ROBERT O DEAN               PHONE NO : 716 440 7362   
1083 DELAWARE AVE                 SE DECISION MADE: 14-FEB-13
BUFFALO NY 14209                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM
ZIMMER, INC.                      510(k) NO: K123918(TRADITIONAL)
ATTN: STEPHEN H MCKELVEY, MA, RAC PHONE NO : 574 372 4944   
345 EAST MAIN ST.                 SE DECISION MADE: 14-FEB-13
WARSAW IN 46580                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES
GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K120673(TRADITIONAL)
ATTN: PATRICK  CHOW               PHONE NO : 008 522 8516789
Building 6 and 7, Zhu Keng IndustrSE DECISION MADE: 14-FEB-13
Shenzhen    CN 518118             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONNECT FOR DA VINCI SURGICAL SYSTEM(S)
INTUITIVE SURGICAL, INC.          510(k) NO: K123840(SPECIAL)
ATTN: CHERECE L JONES             PHONE NO : 408 523 6925   
1266 KIFER ROAD                   SE DECISION MADE: 14-FEB-13
SUNNYVALE CA 94086 5206           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE
DEVON MEDICAL INC.                510(k) NO: K123647(TRADITIONAL)
ATTN: RUTH  WU                    PHONE NO : 610 757 4103   
1100 1ST AVENUE SUITE 100         SE DECISION MADE: 14-FEB-13
KING OF PRUSSIA PA 19406          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC
GEISTLICH PHARMA AG               510(k) NO: K122894(TRADITIONAL)
ATTN: DANIEL A KRACOV             PHONE NO : 202 942 5120   
555 TWELFTH STREET, NW            SE DECISION MADE: 15-FEB-13
WASHINGTON DC 20004 1206          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CPI RAD VISION
COMMUNICATIONS & POWER INDUSTRIES 510(k) NO: K122726(TRADITIONAL)
ATTN: NORM  MORIKAWA              PHONE NO : 905 877 0161
45 RIVER DRIVE                    SE DECISION MADE: 15-FEB-13
GEORGETOWN,ONTARIO    CA L7G 2J4  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 2008 HEMODIALYSIS SORBENT SYSTEM
RENAL SOLUTIONS, INC.             510(k) NO: K123835(SPECIAL)
ATTN: DAVID  VANELLA              PHONE NO : 724 720 2840   
770 COMMONWEALTH DR.              SE DECISION MADE: 15-FEB-13
WARRENDALE PA 15086               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM
ABAXIS, INC.                      510(k) NO: K130200(TRADITIONAL)
ATTN: DENNIS M BLEILE, PHD        PHONE NO : 510 675 6515   
3240 WHIPPLE RD.                  SE DECISION MADE: 15-FEB-13
UNION CITY CA 94587               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION CHEMISTRY III CALIBRATORY
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K123321(TRADITIONAL)
ATTN: ROSE T MARINELLI            PHONE NO : 302 631 8805   
500 GBC DRIVE MS 514              SE DECISION MADE: 15-FEB-13
NEWARK DE 19702                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K123320(TRADITIONAL)
ATTN: ROSE T MARINELLI            PHONE NO : 302 631 8805   
MS 514, PO BOX 6101               SE DECISION MADE: 15-FEB-13
NEWARK DE 19714 6101              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL
ELITECHGROUP                      510(k) NO: K122177(ABBREVIATED)
ATTN: DEBRA K HUTSON              PHONE NO : 425 482 5174   
21720 23RD DR SE SUITE 150        SE DECISION MADE: 15-FEB-13
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE
BM KOREA CO., LTD.                510(k) NO: K122518(SPECIAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 869 3080   
951 STARBUCK ST. UNIT J           SE DECISION MADE: 15-FEB-13
FULLERTON CA 92833                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
SPINEFRONTIER, INC.               510(k) NO: K123164(TRADITIONAL)
ATTN: FREDY H VARELA              PHONE NO : 978 232 3990   
500 CUMMINGS CENTER SUITE 3500    SE DECISION MADE: 15-FEB-13
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND
SHENZHEN DELICATE ELECTRONICS CO.,510(k) NO: K122710(SPECIAL)
ATTN: DIANA  HONG                 PHONE NO : 862 122 815850
P.O. BOX 237-023                  SE DECISION MADE: 15-FEB-13
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GRIDLOCK PLATING SYSTEM
TRILLIANT SURGICAL LTD            510(k) NO: K123525(SPECIAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 15-FEB-13
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS
ORTHO-CLINICAL DIAGNOSTICS, INC.  510(k) NO: K121608(TRADITIONAL)
ATTN: ERIC  SCHAEFFER             PHONE NO : 585 453 3558   
100 INDIGO CREEK DR.              SE DECISION MADE: 15-FEB-13
ROCHESTER NY 14626 5101           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC
OCULUS PRIVATE LIMITED            510(k) NO: K122315(TRADITIONAL)
ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   
33 GOLDEN EAGLE LANE              SE DECISION MADE: 15-FEB-13
LITTLETON CO 80127                510(k) STATEMENT

DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE
WEAR SAFE (MALAYSIA) SDN BHD - FAC510(k) NO: K123469(TRADITIONAL)
ATTN: ALEX  YOONG                 PHONE NO : 603 339 36088
LOT 63616, PT 54924, NO 3, JALAN KSE DECISION MADE: 19-FEB-13
MUKIM KAPAR, KLANG, SELANGOR    MY510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT
ANSELL HEALTHCARE PRODUCTS LLC    510(k) NO: K122477(TRADITIONAL)
ATTN: DONNA  DIGANGI              PHONE NO : 805 541 3344   
4 LOS VERDES DRIVE                SE DECISION MADE: 19-FEB-13
SAN LUIS OBISPO CA 93401          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXUS RMGI
KERR CORPORATION                  510(k) NO: K123595(TRADITIONAL)
ATTN: COLLEEN  BOSWELL            PHONE NO : 714 516 7484   
1717 WEST COLLINS AVENUE          SE DECISION MADE: 19-FEB-13
ORANGE CA 92867                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMMUNIFY PACS VIEWER
COMMUNIFY HEALTH, LLC             510(k) NO: K120851(TRADITIONAL)
ATTN: CHRIS  RELYEA               PHONE NO : 646 526 7111   
160W 71ST 18 FLOOR                SE DECISION MADE: 19-FEB-13
NEW YORK NY 10023                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRADERMAL ADAPTER
WEST PHARMACEUTICAL SERVICES, INC.510(k) NO: K123588(TRADITIONAL)
ATTN: DEBBIE M THOMAS             PHONE NO : 610 594 3105   
101 GORDON DR.                    SE DECISION MADE: 19-FEB-13
LIONVILLE PA 19341                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200
ALLMED SYSTEMS INC.               510(k) NO: K110941(TRADITIONAL)
ATTN: PETER  ALLEN                PHONE NO : 925 468 0433   
9232 KLEMETSON DRIVE              SE DECISION MADE: 19-FEB-13
PLEASANTON CA 94588               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DESARA SL
CALDERA MEDICAL, INC.             510(k) NO: K121928(TRADITIONAL)
ATTN: VICKI  GAIL                 PHONE NO : 818 483 7602   
5171 CLARETON DRIVE               SE DECISION MADE: 19-FEB-13
AGOURA HILLS CA 91301             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAMMOWORKSTATION
IMAGE DIAGNOST INTERNATIONAL GMBH 510(k) NO: K123575(TRADITIONAL)
ATTN: MOUNIR  ZAOUALI             PHONE NO : 331 307045 39
283 RUE DE LA MINIERE             SE DECISION MADE: 19-FEB-13
BUC    FR 78530                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTAS SYSTEM FROM RESTORATION ROBOTICS
RESTORATION ROBOTICS, INC         510(k) NO: K123154(TRADITIONAL)
ATTN: JIM  TALBOT                 PHONE NO : 408 883 6888   
128 BAYTECH DRIVE                 SE DECISION MADE: 19-FEB-13
SAN JOSE CA 95134                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES
INTUITIVE SURGICAL, INC.          510(k) NO: K122532(TRADITIONAL)
ATTN: MELISSA S GONZALEZ          PHONE NO : 408 523 2100   
1266 KIFER ROAD                   SE DECISION MADE: 19-FEB-13
SUNNYVALE CA 94086 5206           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARIX RAD ACQUISITION CONSOLE
COMPANIA MEXICANA DE RADIOLOGIA CG510(k) NO: K123650(TRADITIONAL)
ATTN: CARL  ALLETTO               PHONE NO : 469 684 1980   
1600 MANCHESTER WAY               SE DECISION MADE: 20-FEB-13
CORINTH TX 76210                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
SMITH & NEPHEW, INC.              510(k) NO: K123425(TRADITIONAL)
ATTN: CATHERINE  KILSHAW          PHONE NO : 508 337 4104   
150 MINUTEMAN RD.                 SE DECISION MADE: 20-FEB-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MDU5 PLUS STERILE BAG
BOSTON SCIENTIFIC CORP.           510(k) NO: K123424(TRADITIONAL)
ATTN: LORI R SMITH                PHONE NO : 510 624 1698   
47215 LAKEVIEW BOULEVARD          SE DECISION MADE: 20-FEB-13
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNSPAR ADVANCED
ARDENT INC                        510(k) NO: K123613(ABBREVIATED)
ATTN: DONNA M HARTNETT            PHONE NO : 716 691 2260   
175 Pineview Dr                   SE DECISION MADE: 20-FEB-13
Amherst NY 14228                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COMFORT COUGH
LK CONSULTING GROUP               510(k) NO: K113549(TRADITIONAL)
ATTN: PRISCILLA  CHUNG            PHONE NO : 714 869 3080   
1515 E KATELLA AVE. UNIT 2115     SE DECISION MADE: 21-FEB-13
ANAHEIM CA 92805                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COPRANCOLOR
WHITE PEAKS DENTAL SYSTEMS GMBH & 510(k) NO: K123680(TRADITIONAL)
ATTN: OLIVER  PUCKERT             PHONE NO : 492 812 0645813
LANGHEIDE 9                       SE DECISION MADE: 21-FEB-13
ESSEN    GM 45239                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIN-S MICROIMPLANT
CREEKSIDE ORTHODONTICS            510(k) NO: K120861(TRADITIONAL)
ATTN: JOHN T KALANGE              PHONE NO : 208 342 0212   
136 E. MALLARD DR.                SE DECISION MADE: 21-FEB-13
BOISE ID 83706                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITRO FIL LC
DFL INDUSTRIA E COMERCIO S.A.     510(k) NO: K123824(TRADITIONAL)
ATTN: TARA  CONRAD                PHONE NO : 305 206 6777   
18851 NE 29TH AVE 720             SE DECISION MADE: 21-FEB-13
AVENTURE FL 33180                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM
CALDERA MEDICAL                   510(k) NO: K123337(TRADITIONAL)
ATTN: VICKI  GAIL                 PHONE NO : 818 483 7602   
5171 Clareton Dr                  SE DECISION MADE: 21-FEB-13
Agoura Hills CA 91301             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERCUTANEOUS INTRODUCER KIT
TELEFLEX, INC.                    510(k) NO: K123974(TRADITIONAL)
ATTN: DAWN L MOORE                PHONE NO : 603 532 7706   
50 PLANTATION DR.                 SE DECISION MADE: 21-FEB-13
JAFFREY NH 03452                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL
CIBA VISION CORPORATION           510(k) NO: K123994(TRADITIONAL)
ATTN: MARTINA  HEIM, PH.D., RAC   PHONE NO : 678 415 3565   
11460 JOHNS CREEK PARKWAY         SE DECISION MADE: 21-FEB-13
DULUTH GA 30097                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERIFICATION CONSOLE
VARIAN MEDICAL SYSTEMS            510(k) NO: K124002(TRADITIONAL)
ATTN: PETER J CORONADO            PHONE NO : 650 424 6320   
3100 HANSEN WAY                   SE DECISION MADE: 21-FEB-13
PALO ALTO CA 94304 1034           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CINCHLOCK KNOTLESS SUTURE ANCHOR
PIVOT MEDICAL                     510(k) NO: K123651(TRADITIONAL)
ATTN: JON  COOK                   PHONE NO : 408 774 1452   
247 HUMBOLDT CT.                  SE DECISION MADE: 21-FEB-13
SUNNYVALE CA 94089                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIBER DISK AND BLOCK PERMANENT, TRINIA
BIOLOREN SRL                      510(k) NO: K121735(TRADITIONAL)
ATTN: RATTI  ANDREA               PHONE NO : 39 02 96703261
VIA ALESSANDRO VOLTA 59           SE DECISION MADE: 21-FEB-13
SARONNO, VA    IT 21047           510(k) STATEMENT

DEVICE: EMBLETTA MPR
EMBLA SYSTEMS                     510(k) NO: K122516(TRADITIONAL)
ATTN: JENNIFER  ARMSTRONG         PHONE NO : 613 254 8877
1 HINES RD STE 202                SE DECISION MADE: 21-FEB-13
KANATA    CA K2K 3C7              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LUCENT
SPINAL ELEMENTS, INC.             510(k) NO: K122967(SPECIAL)
ATTN: BENJAMIN A KIMBALL          PHONE NO : 760 607 1816   
2744 LOKER AVE. W. SUITE 100      SE DECISION MADE: 21-FEB-13
CARLSBAD CA 92010                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PEKKTON IVORY
CENDRES & METAUX SA               510(k) NO: K123638(TRADITIONAL)
ATTN: T.  BONGNI                  PHONE NO : 415 836 02302
RUE DE BOUJEAN 122                SE DECISION MADE: 21-FEB-13
BIEL/BIENNE    SZ 2501            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE
HL RUBBER INDUSTRIES SDN BHD      510(k) NO: K130038(TRADITIONAL)
ATTN: NOORZALIZA  AHMAD           PHONE NO : 606 481408 788
LOT 10, KAWASAN PERINDUSTRIAN DIOHSE DECISION MADE: 21-FEB-13
KUALA PILAH, NEGERI SEMBILAN    MY510(k) STATEMENT

DEVICE: MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
MEDICALGORITHMICS S.A.            510(k) NO: K124060(ABBREVIATED)
ATTN: MARTIN  JASINSKI            PHONE NO : 917 941 9581   
245 WEST 107TH ST. SUITE 11A      SE DECISION MADE: 21-FEB-13
NEW YORK NY 10025                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343
CONMED CORPORATION                510(k) NO: K123175(ABBREVIATED)
ATTN: ANNA  D'LIMA                PHONE NO : 315 624 3439   
525 FRENCH RD.                    SE DECISION MADE: 21-FEB-13
UTICA NY 13502                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MRI PATIENT MONITORING SYSTEM (MODEL 865214)
INVIVO CORPORATION                510(k) NO: K124061(SPECIAL)
ATTN: RUSTY  KELLY                PHONE NO : 407 455 6166   
12151 RESEARCH PKWY               SE DECISION MADE: 22-FEB-13
ORLANDO FL 32826                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE
NORTHSTAR HEALTHCARE HOLDINGS     510(k) NO: K122727(ABBREVIATED)
ATTN: MICHAEL  RIORDAN            PHONE NO : 353 214548 255
70 SIR JOHN ROGERSONS QUAY        SE DECISION MADE: 22-FEB-13
DUBLIN 2    IE --                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM
ZIMMER INC.                       510(k) NO: K123459(TRADITIONAL)
ATTN: CAROL  VIERLING, RAC        PHONE NO : 574 372 4964   
P.O. BOX 708                      SE DECISION MADE: 22-FEB-13
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMORY CARDIAC TOOLBOX 4.0
SYNTERMED, INC.                   510(k) NO: K123646(TRADITIONAL)
ATTN: KENNETH  VAN TRAIN          PHONE NO : 888 263 4446   
245 OWENS DR.                     SE DECISION MADE: 22-FEB-13
ANAHEIM CA 92808                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SILKN BLUE
HOME SKINOVATIONS LTD.            510(k) NO: K121435(TRADITIONAL)
ATTN: AMIR  WALDMAN               PHONE NO : 972 547404 616
TAVOR BULD. POB 533               SE DECISION MADE: 22-FEB-13
YOKNEAM ILLIT    IS 20692         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VPULSE
COTHERA, LLC                      510(k) NO: K122640(TRADITIONAL)
ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552 5800   
1331 H STREET NW 12TH FLOOR       SE DECISION MADE: 22-FEB-13
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAMMOMAL INSPIRATION
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K122286(TRADITIONAL)
ATTN: PATRICIA D JONES            PHONE NO : 610 448 3536   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 22-FEB-13
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFESTYLES WARM LOVIN PERSONAL LUBRICANT
ANSELL HEALTHCARE PRODUCTS LLC    510(k) NO: K122720(TRADITIONAL)
ATTN: DONNA  DI GANGI             PHONE NO : 805 541 3344   
4 LOS VERDES DRIVE                SE DECISION MADE: 22-FEB-13
SAN LUIS OBISPO CA 93401          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IRIS - HIGH STRENGTH GLASS CERAMIC
DENTSPLY INTL.                    510(k) NO: K123615(TRADITIONAL)
ATTN: HELEN  LEWIS                PHONE NO : 717 849 4229   
21 W PHILADEPHIA STREET SUITE 60W SE DECISION MADE: 22-FEB-13
YORK PA 17405                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K130058(TRADITIONAL)
ATTN: DAPHNEY  GERMAIN-KOLAWOLE   PHONE NO : 484 896 5691   
REGULATORY AFFAIRS & QUALITY ASSURSE DECISION MADE: 22-FEB-13
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: U-MOTION II ACETABULAR SYSTEM
UNITED ORTHOPEDIC CORP.           510(k) NO: K122185(TRADITIONAL)
ATTN: FANG-YUAN  HO               PHONE NO : 886 357 73351X2212
57 PARK AVE. 2, SCIENCE PARK      SE DECISION MADE: 22-FEB-13
HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MYVISIONTRACK(TM)
VITAL ART AND SCIENCE INCORPORATED510(k) NO: K121738(TRADITIONAL)
ATTN: MICHAEL  BARTLETT           PHONE NO : 214 989 7130   
2725 N. SPRING DR.                SE DECISION MADE: 22-FEB-13
RICHARDSON TX 75082               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERSONA NATURAL TIBIA BASEPLATES
ZIMMER, INC.                      510(k) NO: K130143(SPECIAL)
ATTN: NICOLE J MEREDITH           PHONE NO : 574 372 4517   
P.O. BOX 708                      SE DECISION MADE: 22-FEB-13
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTOS OCT/SLO MICROPERIMETER
OPTOS PLC                         510(k) NO: K121043(TRADITIONAL)
ATTN: RANDY J PREBULA             PHONE NO : 202 637 6548   
555 THIRTEENTH ST. N.W.           SE DECISION MADE: 22-FEB-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INCLUSIVE TAPERED IMPLANT SYSTEM
PRISMATIK DENTALCRAFT, INC.       510(k) NO: K121406(TRADITIONAL)
ATTN: ARMIN  ZEHTABCHI            PHONE NO : 949 399 1940   
2212 DUPONT DR., ST P             SE DECISION MADE: 22-FEB-13
IRVINE CA 92612                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZI BLOWER
DESHUM MEDICAL                    510(k) NO: K121374(TRADITIONAL)
ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207 1245   
5 TIMBER LANE                     SE DECISION MADE: 22-FEB-13
NORTH READING MA 01864            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
HOWMEDICA OSTEONICS CORP.         510(k) NO: K122015(TRADITIONAL)
ATTN: CHRISTIE  PENCINGER         PHONE NO : 201 831 6365   
325 CORPORATE DR                  SE DECISION MADE: 22-FEB-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT
CYTOPHIL INC                      510(k) NO: K121795(TRADITIONAL)
ATTN: BILL  HUBBARD               PHONE NO : 262 642 2765   
2485 CORPORATE CIRCLE SUITE 2     SE DECISION MADE: 22-FEB-13
EAST TROY WI 53120                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: T:CONNECT DATA MANAGEMENT SYSTEM
TANDEM DIABETES CARE, INC.        510(k) NO: K122361(TRADITIONAL)
ATTN: DON  CANAL                  PHONE NO : 858 366 6963   
11045 Roselle St Ste 200          SE DECISION MADE: 22-FEB-13
San Diego CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL
WIPRO GE HEALTHCARE PRIVATE, LTD. 510(k) NO: K123681(TRADITIONAL)
ATTN: SHASHIDHAR  C S             PHONE NO : 91 988 6799814
122 (PART 1) JOHN F WELCH TRDNG CESE DECISION MADE: 22-FEB-13
BANGALORE    IN 560066            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K123187(TRADITIONAL)
ATTN: KAREN  JONES                PHONE NO : 801 565 6231   
12050 LONE PEAK PKWY              SE DECISION MADE: 22-FEB-13
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EOS
EOS IMAGING                       510(k) NO: K123740(SPECIAL)
ATTN: JOHN J SMITH                PHONE NO : 202 637 3638   
555 THIRTEENTH STREET, NW         SE DECISION MADE: 22-FEB-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K123809(SPECIAL)
ATTN: SOWMYA  SHETTY              PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 22-FEB-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K123656(TRADITIONAL)
ATTN: CLAIRE  EVANS               PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 25-FEB-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACHILLES
GE MEDICAL SYSTEMS CHINA CO., LTD.510(k) NO: K123238(TRADITIONAL)
ATTN: LIU  ZHAO                   PHONE NO : 86 510 85278028
NO. 19 CHANGJIANG ROAD NATIONAL HISE DECISION MADE: 25-FEB-13
WUXI, JIANGSU PROVINCE    CH 21402510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING
VITAL IMAGES, INC.                510(k) NO: K122578(TRADITIONAL)
ATTN: IAN  NEMEROV                PHONE NO : 952 487 9622   
5850 Opus Pkwy Ste 300            SE DECISION MADE: 25-FEB-13
MINNETONKA MN 55343               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE ARTAS SYSTEM
RESTORATION ROBOTICS, INC         510(k) NO: K123548(TRADITIONAL)
ATTN: JIM  TALBOT                 PHONE NO : 408 883 6760   
128 BAYTECH DRIVE                 SE DECISION MADE: 25-FEB-13
SAN JOSE CA 95134                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM
BIOMET SPINE (AKA EBI, LLC)       510(k) NO: K123549(TRADITIONAL)
ATTN: VIVIAN  KELLY, MS, RAC      PHONE NO : 973 299 9300   
100 INTERPACE PARKWAY             SE DECISION MADE: 25-FEB-13
PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
INOVA DIAGNOSTICS, INC.           510(k) NO: K120817(TRADITIONAL)
ATTN: ROSANNA  KEIVENS            PHONE NO : 858 586 9900   
9900 OLD GROVE RD.                SE DECISION MADE: 26-FEB-13
SAN DIEGO CA 92131 1638           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTAVI HYDROPHILIC GUIDEWIRE
LAKE REGION MEDICAL               510(k) NO: K124052(TRADITIONAL)
ATTN: TRACY  MEYER                PHONE NO : 952 448 5111   
340 LAKE HAZELTINE DRIVE          SE DECISION MADE: 26-FEB-13
CHASKA MN 55318                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOCORD
DEPUY MITEK INC., A JOHNSON AND JO510(k) NO: K123668(TRADITIONAL)
ATTN: TATYANA  KORSUNSKY          PHONE NO : 508 828 3122   
325 PARAMOUNT DRIVE               SE DECISION MADE: 26-FEB-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEINE OMEGA 500
HEINE OPTOTECHNIK GMBH & CO. KG.  510(k) NO: K123316(ABBREVIATED)
ATTN: JORG  RONNAU                PHONE NO : 49 815 2380
KIENTALSTRASSE 7                  SE DECISION MADE: 26-FEB-13
HERRSCHING    GM D-82211          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: BRIDGE EXTRACELLULAR COLLEGEN MATRIX
HARBOR MEDTECH, INC.              510(k) NO: K122502(TRADITIONAL)
ATTN: JERRY  MEZGER               PHONE NO : 949 679 4800   
4 JENNER SUITE 190                SE DECISION MADE: 26-FEB-13
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123529(TRADITIONAL)
ATTN: PATRICIA D JONES            PHONE NO : 610 448 3536   
51 VALLEY STREAM PKWY.            SE DECISION MADE: 26-FEB-13
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITAL 5 RELEAF CATHETER
VITAL 5                           510(k) NO: K122661(TRADITIONAL)
ATTN: T. WADE  FALLIN             PHONE NO : 435 752 0307   
570 RESEARCH PARK WAY SUITE 102   SE DECISION MADE: 27-FEB-13
NORTH LOGAN UT 84341              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55
BECTON, DICKINSON AND COMPANY     510(k) NO: K130197(SPECIAL)
ATTN: JOHN  ROBERTS               PHONE NO : 201 847 5473   
1 BECTON DRIVE MC237              SE DECISION MADE: 27-FEB-13
FRANKLIN LAKES NJ 07417           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITAL SYNC SYSTEM
COVIDIEN, FORMERLY NELLCOR PURITAN510(k) NO: K123002(TRADITIONAL)
ATTN: KELSEY  LEE                 PHONE NO : 303 305 2760   
6135 Gunbarrel Ave                SE DECISION MADE: 27-FEB-13
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR
ARTHROCARE CORP.                  510(k) NO: K130196(SPECIAL)
ATTN: LAURA  KASPEROWICZ          PHONE NO : 949 585 2406   
15285 ALTON PARKWAY, No. 200      SE DECISION MADE: 27-FEB-13
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS
BIOMET, INC.                      510(k) NO: K123501(SPECIAL)
ATTN: GARY  BAKER                 PHONE NO : 574 267 6639   
56 EAST BELL DR.                  SE DECISION MADE: 27-FEB-13
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PICCOLO COMPOSITE PLATE SYSTEM
CARBOFIX ORTHOPEDICS LTD.         510(k) NO: K130061(SPECIAL)
ATTN: YAEL  RUBIN                 PHONE NO : 972 9 9511511
11 HA'HOSHLIM STREET              SE DECISION MADE: 27-FEB-13
HERZELIYA    IS 46724             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS
DANA PRODUCTS, INC.               510(k) NO: K120592(TRADITIONAL)
ATTN: HARRY  BALA                 PHONE NO : 847 455 2881   
7 COREY DR.                       SE DECISION MADE: 27-FEB-13
SOUTH BARINGTON IL 60010          510(k) STATEMENT

DEVICE: QUATTRO AIR
RESMED LTD.                       510(k) NO: K123979(TRADITIONAL)
ATTN: JIM  CASSI                  PHONE NO : 858 836 6081   
9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 27-FEB-13
SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIMMETRY SACROILIAC JOINT FUSION SYSTEM
ZYGA TECHNOLOGY, INC.             510(k) NO: K130092(SPECIAL)
ATTN: DIANE  BRINZA               PHONE NO : 612 455 1061   
700 10TH AVE SOUTH,  STE 20       SE DECISION MADE: 27-FEB-13
MINNEAPOLIS MN 55415 1745         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
FIAB SPA                          510(k) NO: K123361(TRADITIONAL)
ATTN: FRANCESCO  BATISTINI        PHONE NO : 39 055 84979243
VIA COSTOLI, 4 VICCHIO            SE DECISION MADE: 27-FEB-13
FIRENZE    IT 50039               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIODESIGN ENT REPAIR GRAFT
COOK BIOTECH INCORPRATED          510(k) NO: K121360(TRADITIONAL)
ATTN: MARY A FADERAN, PH.D., RAC  PHONE NO : 765 497 3355   
1425 INNOVATION PLACE             SE DECISION MADE: 27-FEB-13
WEST LAFAYETTE IN 47906 1000      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)
INION OY                          510(k) NO: K123672(TRADITIONAL)
ATTN: KATI  MARTTINEN             PHONE NO : 358 108 306611
LAAKARINKATU 2                    SE DECISION MADE: 27-FEB-13
TAMPERE    FI 33520               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INMODE HAIR REMOVAL (HR) DEVICE
INMODE MD LTD.                    510(k) NO: K123682(TRADITIONAL)
ATTN: AHAVA  STEIN                PHONE NO : 972 9 7670002
20 HATA'AS STR., SUITE 102        SE DECISION MADE: 27-FEB-13
KFAR SABA    IS 44425             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL ELECTROCARDIOGRAPHS
SHENZHEN BIOCARE ELECTRONICS CO., 510(k) NO: K123816(SPECIAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 237-023                  SE DECISION MADE: 27-FEB-13
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES
GE HEALTHCARE FINLAND OY          510(k) NO: K123195(TRADITIONAL)
ATTN: RAUNO  RUOHO                PHONE NO : 358 103941 1
KUORTANEENKATU 2                  SE DECISION MADE: 28-FEB-13
HELSINKI    FI FIN-00510          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CIRCUFLOW 5150
DEVON MEDICAL INC.                510(k) NO: K123959(TRADITIONAL)
ATTN: RUTH  WU                    PHONE NO : 610 757 4103   
1100 1ST AVENUE SUITE 100         SE DECISION MADE: 28-FEB-13
KING OF PRUSSIA PA 19406          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ANKLE TRAUMA SYSTEM
ORTHOPRO LLC                      510(k) NO: K122936(TRADITIONAL)
ATTN: BROCK  JOHNSON              PHONE NO : 801 746 0208   
3450 Highland Dr Ste 303          SE DECISION MADE: 28-FEB-13
Millcreek UT 84106                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING
3M COMPANY                        510(k) NO: K123679(TRADITIONAL)
ATTN: JOANN  HUEHN                PHONE NO : 651 733 9209   
3M CENTER, 2510 CONWAY AVE. BLDG. SE DECISION MADE: 28-FEB-13
ST. PAUL MN 55144                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FACET SCREW SYSTEM
FACET-LINK, INC.                  510(k) NO: K123497(TRADITIONAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET ST. 29TH FLOOR        SE DECISION MADE: 28-FEB-13
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
DEHAI (SHANDONG) MEDICAL GLOVES, C510(k) NO: K123869(TRADITIONAL)
ATTN: RAY  ZHOU                   PHONE NO : 909 548 4828   
12390 EAST END AVE.               SE DECISION MADE: 28-FEB-13
CHINO CA 91710                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COBAS INTEGRA BILIRUBIN DIRECT GEN.2
ROCHE DIAGNOSTICS                 510(k) NO: K123965(TRADITIONAL)
ATTN: SUSAN  HOLLANDBECK          PHONE NO : 317 521 3380   
9115 SOUTH HAGUE ROAD             SE DECISION MADE: 28-FEB-13
INDIANAPOLIS IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEAR ALIGNER ADHESIVE
RELIANCE ORTHODONTIC PRODUCTS, INC510(k) NO: K123348(TRADITIONAL)
ATTN: PAULA  WENDLAND             PHONE NO : 630 773 4009   
1540 WEST THORNDALE AVE.          SE DECISION MADE: 28-FEB-13
ITASCA IL 60143                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DURABLUE STERILIZATION WRAP
CARDINAL HEALTH-MEDICAL PRODUCTS A510(k) NO: K123289(TRADITIONAL)
ATTN: LAVENIA  FORD               PHONE NO : 847 887 3323   
1430 WAUKEGAN RD.                 SE DECISION MADE: 28-FEB-13
MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD
NIDEK MEDICAL PRODUCTS, INC.      510(k) NO: K123738(SPECIAL)
ATTN: VAN  MUTH                   PHONE NO : 205 856 7200   
3949 VALLEY EAST INDUSTRIAL DR    SE DECISION MADE: 28-FEB-13
BIRMINGHAM AL 35217               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE
COOK, INC.                        510(k) NO: K123707(SPECIAL)
ATTN: DAVID  LEHR                 PHONE NO : 812 339 2235   
750 DANIELS WAY                   SE DECISION MADE: 28-FEB-13
BLOOMINGTON IN 47404              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
SURGICAL SPECIALTIES CORP. DBA ANG510(k) NO: K130078(TRADITIONAL)
ATTN: KIRSTEN  STOWELL            PHONE NO : 610 404 3367   
100 DENNIS DR.                    SE DECISION MADE: 28-FEB-13
Reading PA 19606                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES PATIENT SPECIFIC PLATE
SYNTHES INC                       510(k) NO: K122647(TRADITIONAL)
ATTN: ALAN T HALEY                PHONE NO : 484 356 9763   
1301 GOSHEN PARKWAY               SE DECISION MADE: 28-FEB-13
WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERVERTEBRAL BODY FUSION DEVICE
DIO MEDICAL CO., LTD.             510(k) NO: K122872(TRADITIONAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114   
325 N. PUENTE ST UNIT B           SE DECISION MADE: 28-FEB-13
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOFRIC SENSE
WELLSPECT HEALTHCARE              510(k) NO: K123751(TRADITIONAL)
ATTN: ALLISON C KOMIYAMA          PHONE NO : 858 792 1235   
12264 EL CAMINO REAL SUITE 400    SE DECISION MADE: 28-FEB-13
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: U-RIGHT COMPRESSOR NEBULIZER
TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K121969(TRADITIONAL)
ATTN: PINJUNG  CHEN               PHONE NO : 886 266 258188
3F,5F, No.127, Wugong 2nd Rd. WuguSE DECISION MADE: 28-FEB-13
New Taipei City    TW 24888       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE
DRAEGER MEDICAL GMBH              510(k) NO: K121999(TRADITIONAL)
ATTN: BETH  ZIS                   PHONE NO : 978 379 8265   
6 TECH DR                         SE DECISION MADE: 28-FEB-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TI-MAX Z45
NAKANISHI, INC.                   510(k) NO: K121901(TRADITIONAL)
ATTN: FUMIAKI  KANAI              PHONE NO : 813 381 88577
4-4-17 HONGO                      SE DECISION MADE: 28-FEB-13
BUNKYO-KU    JA 113-0033          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EDRAIN CHEST DRAINAGE SYSTEM
ATRIUM MEDICAL CORP.              510(k) NO: K130131(TRADITIONAL)
ATTN: CHRISTINA  CALDERWOOD       PHONE NO : 603 880 1433   
5 Wentworth Dr                    SE DECISION MADE: 28-FEB-13
HUDSON NH 03051                   510(k) STATEMENT


                                                 TOTAL 510(k)s THIS PERIOD   243                                     
                                                 TOTAL WITH SUMMARIES        234                                     
                                                 TOTAL WITH STATEMENTS        9