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Medical Devices

August 2013 510(k) Clearances

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


DEVICE: SOFIA(R) HCG FIA
QUIDEL CORP.                      510(k) NO: K131166(TRADITIONAL)
ATTN: JOHN D TAMERIUS             PHONE NO : 858 552 7908   
10165 MCKELLAR CT.                SE DECISION MADE: 02-AUG-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JBAIDS ANTHRAX DETECTION KIT
BIOFIRE DIAGNOSTICS, INC.         510(k) NO: K131930(TRADITIONAL)
ATTN: CYNTHIA  PHILLIPS           PHONE NO : 801 736 6354   
390 WAKARA WAY                    SE DECISION MADE: 05-AUG-13
SALT LAKE CITY UT 84108           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
ACON LABORATORIES, INC.           510(k) NO: K122553(TRADITIONAL)
ATTN: QIYI  XIE                   PHONE NO : 858 875 8011   
10125 Mesa Rim Road               SE DECISION MADE: 05-AUG-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY
ROCHE DIAGNOSTICS OPERATIONS      510(k) NO: K121610(TRADITIONAL)
ATTN: SUSAN  HOLLANDBECK          PHONE NO : 317 521 3380   
9115 Hague Rd                     SE DECISION MADE: 08-AUG-13
Indianapolis IN 46256             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM
I-SENS, INC.                      510(k) NO: K131419(SPECIAL)
ATTN: CHAE  YUN LIM               PHONE NO : 82 2916 6191
27-36 GWANGUN-RO, NOWON-GU        SE DECISION MADE: 09-AUG-13
SEOUL    KS 139-845               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K130685(TRADITIONAL)
ATTN: ERIKA  AMMIRATI             PHONE NO : 650 949 2768   
575 SHIRLYNN COURT                SE DECISION MADE: 09-AUG-13
LOS ALTOS CA 94022                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II
DIASORIN, INC.                    510(k) NO: K131441(TRADITIONAL)
ATTN: SANDRA  ZIMNIEWICZ          PHONE NO : 651 351 5711   
1951 NORTHWESTERN AVE. P.O. BOX 28SE DECISION MADE: 09-AUG-13
STILLWATER MN 55082 0285          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPARTAN RX CYP2C19 TEST SYSTEM
SPARTAN BIOSCIENCE INC            510(k) NO: K123891(ABBREVIATED)
ATTN: LORRY  HUFFMAN              PHONE NO : 650 730 5030   
3 LAGOON DRIVE, STE 280           SE DECISION MADE: 12-AUG-13
REDWOOD SHORES CA 94065           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOFIA(R) RSV FIA
QUIDEL CORP.                      510(k) NO: K130398(TRADITIONAL)
ATTN: JOHN D TAMERIUS, PH.D.      PHONE NO : 858 552 7908   
10165 MCKELLAR CT.                SE DECISION MADE: 13-AUG-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT
ALFA WASSERMANN                   510(k) NO: K131515(TRADITIONAL)
ATTN: HYMAN  KATZ, PH.D.          PHONE NO : 973 852 0158   
4 Henderson Drive                 SE DECISION MADE: 14-AUG-13
Caldwell NJ 07006                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT
ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K131351(TRADITIONAL)
ATTN: HYMAN  KATZ                 PHONE NO : 973 852 0158   
4 HENDERSON DR.                   SE DECISION MADE: 15-AUG-13
WEST CALDWELL NJ 07006            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EBCHEK BLOOD GLUCOSE MONITORING SYSTEM
VISGENEER, INC.                   510(k) NO: K122181(TRADITIONAL)
ATTN: JACK  YANG                  PHONE NO : 886 351 60111
NO. 188, SEC. 3 GONGDAO 5TH ROAD  SE DECISION MADE: 15-AUG-13
HSINCHU CITY    TW 30069          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT
ALFA WASSERMANN DIAGNOSTICS TECHNO510(k) NO: K131488(TRADITIONAL)
ATTN: HYMAN  KATZ                 PHONE NO : 973 852 0158   
4 HENDERSON DRIVE                 SE DECISION MADE: 19-AUG-13
WEST CALDWELL NJ 07006            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEADCARE (R)  ULTRA (TM) BLOOD LEAD TESTING SYSTEM
MAGELLAN DIAGNOSTICS              510(k) NO: K123563(TRADITIONAL)
ATTN: STUART  NAYLOR              PHONE NO : 978 856 2345   
101 BILLERICA AVE. BLDG #4        SE DECISION MADE: 20-AUG-13
NORTH BILLERICA MA 01862 1271     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM
I-SENS, INC.                      510(k) NO: K130696(TRADITIONAL)
ATTN: CHAE  YUN LIM               PHONE NO : 82 291661 91
27-36 GWANGUN-RO, NOWON-GU        SE DECISION MADE: 21-AUG-13
SEOUL, KOREA    KS 139-845        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMDX FLU A/B AND RSV FOR ABBOTT M2000
INTELLIGENT  MEDICAL  DEVICES,  IN510(k) NO: K131584(TRADITIONAL)
ATTN: FRAN  WHITE                 PHONE NO : 978 927 3808   
180 CABOT ST.                     SE DECISION MADE: 21-AUG-13
BEVERLY MA 01915                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTI CCA-TS2
OPTI MEDICAL SYSTEMS INC.         510(k) NO: K131126(TRADITIONAL)
ATTN: LEN  OWENS                  PHONE NO : 770 510 4444   
235 Hembree Park Dr               SE DECISION MADE: 22-AUG-13
ROSWELL GA 30076                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM
DELBIO INCORPORATION              510(k) NO: K130244(TRADITIONAL)
ATTN: NICKY  PAN                  PHONE NO : 886 3 3596268
3F,6F, No.252, Shangying Road, GuiSE DECISION MADE: 23-AUG-13
Taoyuan County    TW 33341        510(k) STATEMENT

DEVICE: BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY
BECTON, DICKINSON & CO.           510(k) NO: K130268(TRADITIONAL)
ATTN: EMILY  HOWARD               PHONE NO : 410 316 4428   
7 LOVETON CIR.                    SE DECISION MADE: 23-AUG-13
SPARKS MD 21152 0999              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
PHADIA US INC.                    510(k) NO: K122197(TRADITIONAL)
ATTN: MARTIN  MANN                PHONE NO : 269 492 1957   
4169 COMMERCIAL AVE.              SE DECISION MADE: 28-AUG-13
PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II
DIASORIN, INC.                    510(k) NO: K132234(TRADITIONAL)
ATTN: JOHN  ESKDALE               PHONE NO : 651 351 5790   
1951 NORTHWESTERN AVE PO BOX 285  SE DECISION MADE: 28-AUG-13
STILLWATER MN 55082 0285          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUIDEL MOLECULAR INFLUENZA A + B ASSAY
QUIDEL CORP.                      510(k) NO: K131728(TRADITIONAL)
ATTN: RONALD H LOLLAR             PHONE NO : 858 552 1100   
10165 MCKELLAR CT.                SE DECISION MADE: 29-AUG-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOGRAPH DC
VILLA SISTEMI MEDICALI S.P.A.     510(k) NO: K130109(ABBREVIATED)
ATTN: PAOLO  CASAGRANDE SANTIN    PHONE NO : 39 02 48859239
VIADELLE AZALEE, 5                SE DECISION MADE: 01-AUG-13
BUCCINASCO, MILANO    IT 20090    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MYOVISION 3.0 WIREFREE SYSTEM
PRECISION BIOMETRICS, INC.        510(k) NO: K123399(TRADITIONAL)
ATTN: ERIC  CHEN                  PHONE NO : 206 357 6508   
4259 23rd Ave W Ste 400           SE DECISION MADE: 01-AUG-13
Seattle WA 98199                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO
BIOMET MANUFACTURING CORP.        510(k) NO: K130033(TRADITIONAL)
ATTN: ELIZABETH  WRAY             PHONE NO : 574 267 6639   
56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 01-AUG-13
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRA-LOCK OP DENTAL IMPLANT
INTRA-LOCK INTERNATIONAL          510(k) NO: K130140(TRADITIONAL)
ATTN: DIANA  TAYLOR               PHONE NO : 561 447 8282   
6560 WEST ROGERS CIRCLE SUITE 24  SE DECISION MADE: 01-AUG-13
BOCA RATON FL 33487               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE
CHISON MEDICAL IMAGING CO., LTD.  510(k) NO: K131305(TRADITIONAL)
ATTN: BOB  LEIKER                 PHONE NO : 925 556 1302   
7263 CRONIN CIRCLE                SE DECISION MADE: 01-AUG-13
DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K130814(TRADITIONAL)
ATTN: KRISTINE  CHRISTO           PHONE NO : 508 828 3359   
325 PARAMOUNT DR.                 SE DECISION MADE: 01-AUG-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC
CREGANNA MEDICAL DEVICES          510(k) NO: K131079(TRADITIONAL)
ATTN: CHRISTINE  NICHOLS          PHONE NO : 508 351 8632   
386 WEST MAIN STREET SUITE 7      SE DECISION MADE: 01-AUG-13
NORTHBOROUGH MA 01532             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIO VISION MICS AORTIC CLAMPS
CARDIOMEDICAL GMBH                510(k) NO: K123571(TRADITIONAL)
ATTN: ANGELIKA  SCHERP            PHONE NO : 011 312061 25626
AMSTEL 320-1                      SE DECISION MADE: 01-AUG-13
AMSTERDAM, NOORD-HOLLAND    NL 101510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATING MALE LUER
STRYKER ENDOSCOPY                 510(k) NO: K130826(TRADITIONAL)
ATTN: REBECCA  GOLDBERG           PHONE NO : 408 855 6377   
5900 Optical Ct                   SE DECISION MADE: 01-AUG-13
SAN JOSE CA 95138                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING
MAYER LABORATORIES, INC.          510(k) NO: K130345(TRADITIONAL)
ATTN: DAVID P MAYER               PHONE NO : 510 229 5300   
1950 ADDISON STREET, SUITE 101    SE DECISION MADE: 01-AUG-13
BERKELY CA 94704 1182             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD FACS SAMPLE PREP ASSISTANT III
BECTON DICKINSON & CO.            510(k) NO: K131301(TRADITIONAL)
ATTN: KIMBERLY  LIEDTKE           PHONE NO : 408 954 4149   
2350 QUME DRIVE                   SE DECISION MADE: 02-AUG-13
SAN JOSE CA 95131                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLUTIS
QUANTEL MEDICAL                   510(k) NO: K130933(TRADITIONAL)
ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207 1245   
5 TIMBER LANE                     SE DECISION MADE: 02-AUG-13
NORTH READING MA 01864            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
NORMED MEDIZIN-TECHNIK GMBH       510(k) NO: K123347(TRADITIONAL)
ATTN: DAVID C FURR                PHONE NO : 512 906 9654   
8708 CAPEHART COVE                SE DECISION MADE: 02-AUG-13
AUSTIN TX 78733                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE
VECTEC                            510(k) NO: K121370(TRADITIONAL)
ATTN: DIANE  HORWITZ              PHONE NO : 703 307 2921   
2995 STEVEN MARTIN DR.            SE DECISION MADE: 02-AUG-13
FAIRFAX VA 22031                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTELLISAVE AX700 ANESTHESIA SYSTEM
PHILIPS ANESTHESIA CARE           510(k) NO: K122063(TRADITIONAL)
ATTN: NEIL  BATTISTE              PHONE NO : 407 754 4813
ISLEVDALVEJ 211                   SE DECISION MADE: 02-AUG-13
RODOVRE    DA 2610                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIDEKICK AND USHER SUPPORT CATHETERS
C.R. BARD, INC.                   510(k) NO: K131493(TRADITIONAL)
ATTN: TIMOTHY  WADE               PHONE NO : 480 638 2939   
1625 WEST 3RD ST.                 SE DECISION MADE: 02-AUG-13
TEMPE AZ 85281 1740               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING
MEDRAD, INC. / BAYER MEDICAL CARE,510(k) NO: K131517(SPECIAL)
ATTN: LISA A EWING                PHONE NO : 412 406 3780   
ONE MEDRAD DR.                    SE DECISION MADE: 02-AUG-13
INDIANOLA PA 15051                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESTORELLE M, RESTORELLE XL
COLOPLAST CORP.                   510(k) NO: K132061(SPECIAL)
ATTN: TIM  CRABTREE               PHONE NO : 612 302 4299   
1601 WEST RIVER                   SE DECISION MADE: 02-AUG-13
MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
SMITH & NEPHEW, INC.              510(k) NO: K130748(TRADITIONAL)
ATTN: BRADLEY  HEIL               PHONE NO : 901 399 6339   
1450 BROOKS RD.                   SE DECISION MADE: 04-AUG-13
MEMPHIS TN 38116                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES
SEN MU TECHNOLOGY CO., LTD.       510(k) NO: K122610(TRADITIONAL)
ATTN: MING-YIE  JN, PH.D.         PHONE NO : 886 7 3113389
NO. 15-2, LANE 26, MINCYUAN 1SR RDSE DECISION MADE: 05-AUG-13
KAOHSIUNG CITY    TW 802          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM
STELKAST COMPANY                  510(k) NO: K122883(TRADITIONAL)
ATTN: DAVID  STUMPO               PHONE NO : 724 731 2208   
200 HIDDEN VALLEY RD.             SE DECISION MADE: 05-AUG-13
MCMURRAY PA 15317                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYMMETRY KERRISON DISPOSABLE TIP RONGEURS
SYMMETRY SURGICAL                 510(k) NO: K130541(TRADITIONAL)
ATTN: DALENE  BINKLEY             PHONE NO : 260 244 4189   
1927 N. ARTHUR DR.                SE DECISION MADE: 05-AUG-13
COLUMBIA CITY IN 46725            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRIMATRIX DERMAL REPAIR SCAFFOLD
TEI BIOSCIENCES INC.              510(k) NO: K131286(TRADITIONAL)
ATTN: KENNETH  JAMES              PHONE NO : 617 268 1616   
7 ELKINS ST.                      SE DECISION MADE: 05-AUG-13
BOSTON MA 02127                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
SAUFLON PHARMACEUTICALS, LTD.     510(k) NO: K130342(TRADITIONAL)
ATTN: CHRISTOPHER  SMEJKAL        PHONE NO : 44 208 3224200
49-53 YORK ST.                    SE DECISION MADE: 05-AUG-13
TWICKENHAM, MIDDLESEX    UK TW1-3L510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME
LEMAITRE VASCULAR, INC.           510(k) NO: K132190(TRADITIONAL)
ATTN: ANNA  KASSERIS              PHONE NO : 781 221 2266   
63 2ND AVENUE                     SE DECISION MADE: 05-AUG-13
BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EPIDOSE
SUN NUCLEAR CORPORATION           510(k) NO: K131704(TRADITIONAL)
ATTN: JEFF  KAPATOES              PHONE NO : 321 259 6862   
3275 Suntree Blvd                 SE DECISION MADE: 05-AUG-13
Melbourne FL 32940                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET
BRACCO DIAGNOSTIC, INC.           510(k) NO: K123047(TRADITIONAL)
ATTN: TRACEY  ALEXANDER           PHONE NO : 609 524 2865   
107 COLLEGE ROAD                  SE DECISION MADE: 06-AUG-13
PRINCETON NJ 08540                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM
BIOMET, INC.                      510(k) NO: K130126(TRADITIONAL)
ATTN: TRACY B JOHNSON             PHONE NO : 574 267 6639   
56 EAST BELL DR.                  SE DECISION MADE: 06-AUG-13
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARSPEC SINGLE USE VAGINAL SPECULUM
CLEARSPEC LLC                     510(k) NO: K130046(TRADITIONAL)
ATTN: IRA  DUESLER                PHONE NO : 315 868 5645   
603 GRANT STREET                  SE DECISION MADE: 06-AUG-13
HERKIMER NY 13350                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OVUSENSE
FERTILITY FOCUS LTD               510(k) NO: K122337(TRADITIONAL)
ATTN: PENNY  NORTHCUTT            PHONE NO : 678 428 6978   
717 LAKEGLEN DRIVE                SE DECISION MADE: 06-AUG-13
SUWANEE GA 30024                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL
ORTHO KINEMATICS, INC.            510(k) NO: K130743(TRADITIONAL)
ATTN: JOHN J SMITH                PHONE NO : 202 637 3638   
555 13TH STREET NW                SE DECISION MADE: 06-AUG-13
WASHINGTON DC 20005 3096          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MENICON NECT CONTACT LENS CASE
FORESIGHT REGULATORY STRATEGIES   510(k) NO: K131875(TRADITIONAL)
ATTN: ELLEN M BEUCLER             PHONE NO : 978 658 6888   
187 BALLARDVALE STREET SUITE 180  SE DECISION MADE: 06-AUG-13
WILMINGTON MA 01887 4461          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0
OSTIAL CORPORATION                510(k) NO: K131450(SPECIAL)
ATTN: JAKE  WOLENBERG             PHONE NO : 650 903 9100   
510 CLYDE AVENUE                  SE DECISION MADE: 06-AUG-13
MOUNTAIN VIEW CA 94043            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA       510(k) NO: K132111(SPECIAL)
ATTN: LAUREN  KAMER               PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 06-AUG-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TIARRAY DENTAL IMPLANT SYSTEM
NASSEO, INC.                      510(k) NO: K131345(TRADITIONAL)
ATTN: ALLISON C KOMIYAMA          PHONE NO : 858 792 1235   
12264 EL CAMINO REAL, SUITE 400   SE DECISION MADE: 07-AUG-13
SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUADCUT
MEDTRONIC NAVIGATION, INC.        510(k) NO: K130608(TRADITIONAL)
ATTN: SHARON  MCDERMOTT           PHONE NO : 720 890 2247   
826 COAL CREEK CIR.               SE DECISION MADE: 07-AUG-13
LOUISVILLE CO 80027               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRA TITANIUM BONE WEDGE
ASCENSION ORTHOPEDIC              510(k) NO: K131360(TRADITIONAL)
ATTN: KYLA  KARA                  PHONE NO : 609 936 6926   
8700 CAMERON RD., STE. 100        SE DECISION MADE: 07-AUG-13
Austin TX 78754                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROTHELIAL
MUELLER MEDICAL INTERNATIONAL LLC 510(k) NO: K123904(TRADITIONAL)
ATTN: RICKY W MCCULLOUGH MD       PHONE NO : 401 397 6203   
48A MOOSUP VALLEY ROAD            SE DECISION MADE: 07-AUG-13
FOSTER RI 02825                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIREBIRD SPINAL FIXATION SYSTEM
ORTHOFIX, INC.                    510(k) NO: K130932(TRADITIONAL)
ATTN: JACKI  GEREN                PHONE NO : 214 937 2100   
3451 PLANO PARKWAY                SE DECISION MADE: 07-AUG-13
LEWISVILLE TX 75056               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FOREIGN BODY HOOD
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K130148(TRADITIONAL)
ATTN: CARROLL  MARTIN             PHONE NO : 440 639 4494   
5976 Heisley Rd                   SE DECISION MADE: 07-AUG-13
Mentor OH 44060                   510(k) STATEMENT

DEVICE: ACTIVE BREATHING COORDINATOR
AKTINA MEDICAL CORP.              510(k) NO: K131313(TRADITIONAL)
ATTN: TONY  SPACCAROTELLA         PHONE NO : 845 268 0101   
360 NORTH ROUTE 9W                SE DECISION MADE: 07-AUG-13
Congers NY 10920                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RSH BILIARY STONE REMOVAL DEVICE
RSH LLC                           510(k) NO: K131642(TRADITIONAL)
ATTN: AMY  SPRINGS                PHONE NO : 713 679 8657   
5121 FEAGAN ST.                   SE DECISION MADE: 07-AUG-13
HOUSTON TX 77007                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: I.T.S. EXTREMITY FIXATION SYSTEMS
I.T.S. GMBH                       510(k) NO: K131722(TRADITIONAL)
ATTN: AL  LIPPINCOTT              PHONE NO : 952 492 5858   
3150 E. 200TH STREET              SE DECISION MADE: 07-AUG-13
PRIOR LAKE MN 55372               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
BECTON, DICKINSON AND COMPANY     510(k) NO: K132256(SPECIAL)
ATTN: GREGORY P PAYNE, RAC        PHONE NO : 858 795 7890   
10865 ROAD TO THE CURE SUITE 200  SE DECISION MADE: 07-AUG-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
BECTON, DICKINSON AND COMPANY     510(k) NO: K132259(SPECIAL)
ATTN: GREGORY P PAYNE, RAC        PHONE NO : 858 795 7890   
10865 ROAD TO THE CURE SUITE 200  SE DECISION MADE: 07-AUG-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KATIA SYSTEM
SHANGHAI SANYOU MEDICAL CO, LTD   510(k) NO: K131512(TRADITIONAL)
ATTN: KIMBERLY  STROHKIRCH        PHONE NO : 901 361 2037   
3416 ROXEE RUN COVE               SE DECISION MADE: 07-AUG-13
BARTLETT TN 38133                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN
INDUSTRIAL CLOTHINGS, LTD.        510(k) NO: K130846(TRADITIONAL)
ATTN: S.N.  HARI                  PHONE NO : 009 43654 22200
D17, SEETHAWAKA EXPORT PROCESSING SE DECISION MADE: 08-AUG-13
AVISSAWELLA, WESTERN PROVINCE    C510(k) STATEMENT

DEVICE: MP VIAL ADAPTER 13MM
MEDIMOP MEDICAL PROJECTS, LTD.    510(k) NO: K130179(TRADITIONAL)
ATTN: ILANIT  GOLDGRABER          PHONE NO : 972 977571 22
17 HATIDHAR ST.                   SE DECISION MADE: 08-AUG-13
RA'ANANA    IS 4366519            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXPANDABLE LUMBAR INTERBODY SYSTEM
NUVASIVE, INCORPORATED            510(k) NO: K130820(TRADITIONAL)
ATTN: JEREMY  MARKOVICH           PHONE NO : 858 309 3783   
7475 LUSK BOULEVARD               SE DECISION MADE: 08-AUG-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PEDIGUARD NERVE DETECTOR SYSTEM
SPINEGUARD, S.A.                  510(k) NO: K123390(TRADITIONAL)
ATTN: JOHN J SMITH, M.D. J.D.     PHONE NO : 202 637 3638   
555 13TH ST. NW                   SE DECISION MADE: 08-AUG-13
WASHINGTON DC 20004               510(k) STATEMENT

DEVICE: PANPAC VAGINAL DILATORS
PANPAC MEDICAL CORPORATION        510(k) NO: K130273(TRADITIONAL)
ATTN: YEN-MING  PAN               PHONE NO : 886 2 86472242
6F-1, 2 NO. 202, SEC 3 TA-TONG ROASE DECISION MADE: 08-AUG-13
SHI-CHIH DISTRICT, NEW TAIPEI CITY510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM
OSSEUS FUSION SYSTEMS, LLC        510(k) NO: K131810(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OACKWOOD BLVD                SE DECISION MADE: 08-AUG-13
ROUND ROCK TX 75205               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM
TIANJIN WALKMAN BIOMATERIAL CO., L510(k) NO: K131759(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 120-119                  SE DECISION MADE: 08-AUG-13
SHANGHAI    CH 200120             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NMI PORT II CATHETER
NAVILYST MEDICAL, INC.            510(k) NO: K131694(ABBREVIATED)
ATTN: BRANDON M BRACKETT          PHONE NO : 508 658 7984   
26 FOREST STREET                  SE DECISION MADE: 08-AUG-13
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE
TERUMO BCT, INC..                 510(k) NO: K131744(TRADITIONAL)
ATTN: TINA  O'BRIEN               PHONE NO : 303 239 2082   
10811 WEST COLLINS AVE.           SE DECISION MADE: 08-AUG-13
Lakewood CO 80215                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2
RANDOX LABORATORIES, LTD.         510(k) NO: K132090(TRADITIONAL)
ATTN: PAULINE  ARMSTRONG          PHONE NO : 028 944 22413
55 DIAMOND RD.                    SE DECISION MADE: 08-AUG-13
CRUMLIN, COUNTY ANTRIM    UK BT29 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GE DATEX-OHMEDA AVANCE CS2
DATEX-OHMEDA                      510(k) NO: K131945(SPECIAL)
ATTN: JAMES P RASKOB              PHONE NO : 608 221 1551   
3030 OHMEDA DRIVE, P.O. BOX 7550  SE DECISION MADE: 08-AUG-13
MADISON WI 53707 7550             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM
CAPTIVA SPINE                     510(k) NO: K131538(SPECIAL)
ATTN: RICH  JANSEN                PHONE NO : 612 281 5505   
13540 GUILD AVE                   SE DECISION MADE: 08-AUG-13
APPLE VALLY MN 55124              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PTS-X SIZING BALLOON CATHETER
NUMED, INC.                       510(k) NO: K131869(SPECIAL)
ATTN: NICHELLE  LAFLESH           PHONE NO : 315 328 4491   
2880 MAIN ST.                     SE DECISION MADE: 08-AUG-13
HOPKINTON NY 12965                510(k) STATEMENT

DEVICE: PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
BIOMET MICROFIXATION              510(k) NO: K131674(SPECIAL)
ATTN: ELIZABETH  WHEELER          PHONE NO : 904 741 4400   
1520 TRADEPORT DRIVE              SE DECISION MADE: 08-AUG-13
JACKSONVILLE FL 32218             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CROSSTREES PVA POD
CROSSTREES MEDICAL, INC.          510(k) NO: K130089(TRADITIONAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET ST., 28TH FLOOR       SE DECISION MADE: 09-AUG-13
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ICONACY I-HIP SYSTEM
ICONACY ORTHOPEDIC IMPLANTS, LLC  510(k) NO: K131279(SPECIAL)
ATTN: MARC E RUHLING              PHONE NO : 574 549 7710   
4130 CORRIDOR DRIVE               SE DECISION MADE: 09-AUG-13
WARSAW IN 46582                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEL-GE CARE INNOVATIONS CONNECT RCM
INTEL-GE CARE INNOVATIONS LLC     510(k) NO: K130821(ABBREVIATED)
ATTN: MAUREEN  GLYNN              PHONE NO : 916 847 7794   
3721 DOUGLAS BOULEVARD SUITE 100  SE DECISION MADE: 09-AUG-13
ROSEVILLE CA 95661                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHROCARE HEAD AND NECK COBLATION WAND
ARTHROCARE CORPORATION            510(k) NO: K131205(TRADITIONAL)
ATTN: MITCHELL A DHORITY          PHONE NO : 512 358 5995   
7000 West William Cannon Drive    SE DECISION MADE: 09-AUG-13
Austin TX 78735                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E-TENG MODEL EOR 1
E-TENG TECHNOLOGY, INC.           510(k) NO: K122562(TRADITIONAL)
ATTN: JUNNATA  CHANG              PHONE NO : 886 4 22465396
16F-2 (16A), NO. 462, SEC. 2 CHONGSE DECISION MADE: 09-AUG-13
TAICHUNG    TW 406                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER
BOSTON SCIENTIFIC CORP.           510(k) NO: K130484(SPECIAL)
ATTN: ANDREW  NGUYEN              PHONE NO : 508 683 6496   
100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 09-AUG-13
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCU-CHEK AVIVA PLUS TEST STRIP
ROCHE DIAGNOSTICS OPERATIONS INC  510(k) NO: K131029(SPECIAL)
ATTN: KHONE  SAYSANA              PHONE NO : 317 521 7593   
9115 Hague Rd                     SE DECISION MADE: 09-AUG-13
Indianapolis IN 46250             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROFTHAND MECHANICAL WHEELCHAIR
HARMONY HILL INTERNATIONAL        510(k) NO: K123076(ABBREVIATED)
ATTN: TINA  LAI                   PHONE NO : 886 226557 717
RM. 1068, 10F, H BLDG. OF NKSP, NOSE DECISION MADE: 09-AUG-13
TAIPEI    TW 11503                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIVE VIEW PANEL (LVP)
NEUROTRONICS, INC.                510(k) NO: K131415(TRADITIONAL)
ATTN: DAVID  PEZET                PHONE NO : 352 372 9955   
3600 NW 43RD ST, STE F1           SE DECISION MADE: 09-AUG-13
Gainesville FL 32606              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRODESSE PROFLU+ ASSAY
GEN-PROBE PRODESSE, INC.          510(k) NO: K132129(SPECIAL)
ATTN: EMILY  ZIEGLER              PHONE NO : 262 953 8421   
20925 CROSSROADS CIRCLE           SE DECISION MADE: 09-AUG-13
Waukesha WI 53186                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FACET SCREW SYSTEM
SPINAL USA                        510(k) NO: K130863(TRADITIONAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET STREET, 29TH FLOOR    SE DECISION MADE: 09-AUG-13
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUREFIX INTERSPINOUS FUSION SYSTEM
JG SPINE, LLC                     510(k) NO: K124014(TRADITIONAL)
ATTN: JOHN  KAPITAN               PHONE NO : 704 843 7852   
100 E. SOUTH MAIN ST.             SE DECISION MADE: 09-AUG-13
WAXHAW NC 28173                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT
MERETE MEDICAL GMBH               510(k) NO: K132226(SPECIAL)
ATTN: EMMANUEL  ANAPLIOTIS        PHONE NO : 49 30 779980114
102 ALT LANKWITZ                  SE DECISION MADE: 09-AUG-13
BERLIN    GM D-12247              510(k) STATEMENT

DEVICE: CAPSURE PS SYSTEM
SPINE WAVE, INC.                  510(k) NO: K132154(SPECIAL)
ATTN: JOSEPH  MERCADO             PHONE NO : 203 712 1839   
THREE ENTERPRISE DR. SUITE 210    SE DECISION MADE: 09-AUG-13
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORE PEDICLE SCREW SYSTEM
CORE-NEXUS                        510(k) NO: K131522(TRADITIONAL)
ATTN: LISA  PETERSON              PHONE NO : 512 507 0746   
14001 HUNTERS PASS                SE DECISION MADE: 09-AUG-13
AUSTIN TX 78734                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM
ZIMMER INC.                       510(k) NO: K123553(TRADITIONAL)
ATTN: ALLISON  SCOTT, RAC         PHONE NO : 317 569 9500   
9001 WESLEYAN ROAD, SUITE 200     SE DECISION MADE: 09-AUG-13
INDIANAPOLIS IN 46268             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QLAB QUANTIFICATION SOFTWARE
PHILIPS ULTRASOUND, INC.          510(k) NO: K132165(TRADITIONAL)
ATTN: PENNY  GRECO                PHONE NO : 978 975 4615   
3000 MINUTEMAN RD.                SE DECISION MADE: 09-AUG-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: FAHL TRACHEOSTOMY TUBES (MULTIPLE)
ANDREAS FAHL MEDIZINTECHNIK-VERTRI510(k) NO: K123699(TRADITIONAL)
ATTN: CLAUDIA  WINTERSCHLADEN     PHONE NO : 49 220 329800
AUGUST-HORCH-STR. 4A              SE DECISION MADE: 12-AUG-13
KOELN    GM 51149                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM
GIVEN IMAGING LTD.                510(k) NO: K123864(TRADITIONAL)
ATTN: TIM  THOMAS                 PHONE NO : 770 662 0870   
SHAAR YOKNEAM (HERMON BUILDING NEWSE DECISION MADE: 12-AUG-13
YOKNEAM      (P.O.BOX 258)    IS 2510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIVORTE BVF LITE
VIVORTE, INC                      510(k) NO: K131133(TRADITIONAL)
ATTN: STEPHEN J PEOPLES           PHONE NO : 260 645 0327   
5010 LODGE PLE LANE               SE DECISION MADE: 12-AUG-13
FORT WAYNE IN 46814               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHILIPS SURESIGNS CENTRAL
PHILIPS MEDICAL SYSTEMS           510(k) NO: K131032(TRADITIONAL)
ATTN: MARY  KRUITWAGEN            PHONE NO : 978 659 4932   
3000 Minuteman Rd                 SE DECISION MADE: 12-AUG-13
ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECTROMAGNETIC TRANSMITTING STYLET
CORPAK MEDSYSTEMS                 510(k) NO: K131532(TRADITIONAL)
ATTN: STEPHANIE  WASIELEWSKI      PHONE NO : 847 403 3484   
1001 Asbury Dr                    SE DECISION MADE: 12-AUG-13
Buffalo Grove IL 60089            510(k) STATEMENT

DEVICE: CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER
PENDRACARE INTERNATIONAL, B.V.    510(k) NO: K132197(SPECIAL)
ATTN: TOM  NOLAN                  PHONE NO : 919 878 7888   
7205 LAKETREE DR                  SE DECISION MADE: 12-AUG-13
RALEIGH NC 27615                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K131536(TRADITIONAL)
ATTN: GARO  MIMARYAN              PHONE NO : 914 524 3270   
511 BENEDICT AVE.                 SE DECISION MADE: 12-AUG-13
TARRYTOWN NY 10591                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PANA SPRAY PLUS
NSK AMERICA CORP.                 510(k) NO: K131014(TRADITIONAL)
ATTN: DIANE  RUTHERFORD           PHONE NO : 972 480 9554   
1201 RICHARDSON DR. SUITE 280     SE DECISION MADE: 12-AUG-13
RICHARDSON TX 75080               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOPER PTCA BALLOON CATHETER
LEPU MEDICAL TECHNOLOGY (BEIJING) 510(k) NO: K123473(TRADITIONAL)
ATTN: ARTHUR  GODDARD             PHONE NO : 216 233 5722   
1531 FELTON ROAD                  SE DECISION MADE: 13-AUG-13
SOUTH EUCLID OH 44121 2722        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACE MONOPOLAR ATTACHMENT
BIOECONEER INC.                   510(k) NO: K123061(TRADITIONAL)
ATTN: MICHAEL  LEE                PHONE NO : 886 22 8096995
NO. 45, MINSHENG RD. DANSHUI DIST.SE DECISION MADE: 13-AUG-13
NEW TAIPEI CITY    TW 251         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVICEL APPLICATION DEVICE
ETHICON INC (ON BEHALF OF OMRIX BI510(k) NO: K130900(TRADITIONAL)
ATTN: SHIKHA  GOLA                PHONE NO : 908 218 2478   
ROUTE 22 WEST                     SE DECISION MADE: 13-AUG-13
SOMERVILLE NJ 08876               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HUMELOCK II CEMENTED SHOULDER SYSTEM
FX SOLUTIONS                      510(k) NO: K123814(TRADITIONAL)
ATTN: JEAN-JACQUES  MARTIN        PHONE NO : 33 47 4553555
1663 RUE DE MAJORNAS              SE DECISION MADE: 13-AUG-13
VIRIAT    FR 01440                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTIFLOW II FLOWABLE COMPOSITE, LC
PAC-DENT INTERNATIONAL, INC.      510(k) NO: K130672(TRADITIONAL)
ATTN: WENYING  ZHU                PHONE NO : 909 839 0888   
21038 Commerce Pointe Dr.         SE DECISION MADE: 13-AUG-13
Walnut CA 91789                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S4C NAVIGATION INSTRUMENTS
AESCULAP IMPLANT SYSTEM, INC.     510(k) NO: K130887(TRADITIONAL)
ATTN: LISA M BOYLE                PHONE NO : 610 984 9274   
3773 CORPORATE PARKWAY            SE DECISION MADE: 13-AUG-13
CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT
HAGER & MEISINGER GMBH            510(k) NO: K130682(TRADITIONAL)
ATTN: WIEBKE  STOLTEN             PHONE NO : 004 921 312012388
HANSEMANNSTRASSE 10               SE DECISION MADE: 13-AUG-13
NEUSS    GM D-41468               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRECISE SHP DIODE LASER
CAO GROUP, INC.                   510(k) NO: K123443(TRADITIONAL)
ATTN: ROBERT K LARSEN             PHONE NO : 801 256 9282   
4628 WEST SKYHAWK DRIVE           SE DECISION MADE: 13-AUG-13
WEST JORDAN UT 84084              510(k) STATEMENT

DEVICE: EASYSTAND BANTAM MEDIUM
ALTIMATE MEDICAL, INC.            510(k) NO: K123834(TRADITIONAL)
ATTN: STACEY  FRANK               PHONE NO : 507 697 6393   
262 WEST FIRST ST.                SE DECISION MADE: 13-AUG-13
MORTON MN 56270                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXTRICARE NPWT FOOT DRESSING
DEVON MEDICAL INC.                510(k) NO: K131464(SPECIAL)
ATTN: RUTH  WU                    PHONE NO : 610 757 4103   
1100 1ST AVENUE SUITE 200         SE DECISION MADE: 13-AUG-13
KING OF PRUSSIA PA 19406          510(k) STATEMENT

DEVICE: AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM
ASEPTICO, INC.                    510(k) NO: K130693(TRADITIONAL)
ATTN: CHERIE  TREGONING           PHONE NO : 425 487 3157   
8333 216th St SE                  SE DECISION MADE: 14-AUG-13
WOODINVILLE WA 98072              510(k) STATEMENT

DEVICE: AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR
AGELESS HEALTH INDUSTRIAL         510(k) NO: K123882(TRADITIONAL)
ATTN: VICTOR  WAN                 PHONE NO : 076 981 158038
3F, A1 BLDG, DONGSHEN SIMA INDUSTRSE DECISION MADE: 14-AUG-13
DONGGUAN, GUANGDONG    CH 523570  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
SOUTHERN SPINE, LLC               510(k) NO: K130948(TRADITIONAL)
ATTN: JULIE  STEPHENS             PHONE NO : 678 513 0693   
111 LAUREL RIDGE DRIVE            SE DECISION MADE: 14-AUG-13
ALPHARETTA GA 30004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM
MFS - MEDICAL FLOW SYSTEMS LTD    510(k) NO: K131247(TRADITIONAL)
ATTN: OFER  SHAY                  PHONE NO : 972 4 9808280
ELT BUILDING, DORA INDUSTRIAL ZONESE DECISION MADE: 14-AUG-13
SHLOMI    IS 22832                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MERON APPLICATION CAPSULES
VOCO GMBH                         510(k) NO: K130421(TRADITIONAL)
ATTN: T.  GERKENSMEIER            PHONE NO : 49 472171 9200
ANTON-FLETTNER-STRASSE 1-3        SE DECISION MADE: 14-AUG-13
CUXHAVEN    GM D-27472            510(k) STATEMENT

DEVICE: GLIDE DEVICE
HOME SKINOVATIONS LTD.            510(k) NO: K131870(SPECIAL)
ATTN: AHAVA  STEIN                PHONE NO : 972 976 70002
20 HATA'AS STR., STE 102          SE DECISION MADE: 14-AUG-13
KFAR SABA    IS 44425             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
X-SPINE SYSTEMS, INC.             510(k) NO: K131951(TRADITIONAL)
ATTN: DAVID  KIRSCHMAN            PHONE NO : 937 847 8400   
452 ALEXANDERSVILLE RD.           SE DECISION MADE: 14-AUG-13
MIAMISBURG OH 45342               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER
MEDTRONIC NAVIGATION, INC.        510(k) NO: K131425(TRADITIONAL)
ATTN: REGINA  HOLMES              PHONE NO : 901 396 3133   
1800 PYRAMID PLACE                SE DECISION MADE: 14-AUG-13
MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROADENO+ ASSAY
GEN-PROBE PRODESSE, INC           510(k) NO: K132159(SPECIAL)
ATTN: EMILY  ZIEGLER              PHONE NO : 262 953 8421   
20925 CROSSROADS CIRCLE           SE DECISION MADE: 14-AUG-13
WAUKESHA WI 53186                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRO HMPV+ ASSAY
GEN-PROBE PRODESSE, INC           510(k) NO: K132200(SPECIAL)
ATTN: EMILY  ZIEGLER              PHONE NO : 262 953 8421   
20925 CROSSROADS CIRCLE           SE DECISION MADE: 14-AUG-13
WAUKESHA WI 53186                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LASSO NAV DUO LOOP CATHETER
BIOSENSE WEBSTER, INC.            510(k) NO: K130602(TRADITIONAL)
ATTN: JOHN  JIMENEZ               PHONE NO : 909 839 8534   
3333 DIAMOND CANYON RD            SE DECISION MADE: 14-AUG-13
DIAMOND BAR CA 91765              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
NOVO NORDISK INC.                 510(k) NO: K123766(TRADITIONAL)
ATTN: LOIS  KOTKOSKIE, PH. D      PHONE NO : 609 987 5973   
P.O. BOX 846                      SE DECISION MADE: 15-AUG-13
PLAINSBORO NJ 08536               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOVISION
EWOO SOFT CO., LTD                510(k) NO: K131570(TRADITIONAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
12946 KIMBERLEY LN                SE DECISION MADE: 15-AUG-13
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LVIVO EF SYSTEM
DIACARDIO, LTD                    510(k) NO: K130779(TRADITIONAL)
ATTN: GEORGE  HATTUB              PHONE NO : 508 479 6116   
291 HILLSIDE AVE.                 SE DECISION MADE: 15-AUG-13
SOMERSET MA 02726                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GMK HINGE
MEDACTA INTERNATIONAL             510(k) NO: K130299(TRADITIONAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 322 3289   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 15-AUG-13
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHOHELIX STAPLE SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K130832(TRADITIONAL)
ATTN: BRIAN  HOCKETT              PHONE NO : 330 869 9562   
1065 MEDINA ROAD SUITE 500        SE DECISION MADE: 15-AUG-13
MEDINA OH 44256                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYNASENSE SYSTEM
CENTAURI MEDICAL, INC.            510(k) NO: K130752(TRADITIONAL)
ATTN: LORI  ADELS                 PHONE NO : 408 400 0856   
755 N MATHILDA AVE STE 100        SE DECISION MADE: 15-AUG-13
SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ANYONETM INTERNAL IMPLANT SYSTEM
MEGAGEN IMPLANT CO., LTD          510(k) NO: K123988(TRADITIONAL)
ATTN: APRIL  LEE                  PHONE NO : 714 525 0114   
325 N PUENTE ST. UNIT B           SE DECISION MADE: 15-AUG-13
BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GYMFORM ABS-A-ROUND
WELL BRAIN INTERNATIONAL, LTD.    510(k) NO: K130074(TRADITIONAL)
ATTN: VICTOR K WAI                PHONE NO : 852 261 90833
RM.1212, 12 FL, HARBOUR CRYSTAL CESE DECISION MADE: 15-AUG-13
HONG KONG    CH 999077            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
MEDICAL COMPONENTS INC            510(k) NO: K130687(TRADITIONAL)
ATTN: JESSICA  LEO                PHONE NO : 215 256 4201   
1499 DELP DRIVE                   SE DECISION MADE: 15-AUG-13
HARLEYSVILLE PA 19438             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMPLATZER TORQ VUE LP DELIVERY SYSTEM
ST. JUDE MEDICAL                  510(k) NO: K131063(TRADITIONAL)
ATTN: HEATHER  TAYLOR             PHONE NO : 651 756 5765   
5050 NATHAN LANE NORTH            SE DECISION MADE: 15-AUG-13
PLYMOUTH MN 55442                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONTRAST CONSERVATION SYSTEM
OSPREY MEDICAL, INC.              510(k) NO: K131478(TRADITIONAL)
ATTN: JILL  MUNSINGER             PHONE NO : 952 955 8230   
7600 EXECUTIVE DR                 SE DECISION MADE: 15-AUG-13
EDEN PRAIRIE MN 55344             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K132341(TRADITIONAL)
ATTN: ZHAI  PEI                   PHONE NO : 
MINDRAY BLDG. KEJI 12TH RD S. HI-TSE DECISION MADE: 15-AUG-13
NANSHAN, SHENZHEN    CH 518057    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: KINEX BIOACTIVE
GLOBUS MEDICAL INC.               510(k) NO: K130392(TRADITIONAL)
ATTN: SARAH MARIE  FITZGERALD     PHONE NO : 610 930 1800   
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 15-AUG-13
AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
NIPRO DIAGNOSTICS, INC.           510(k) NO: K132072(SPECIAL)
ATTN: BETH  FOSTER                PHONE NO : 954 677 9201   
2400 NW 55TH COURT                SE DECISION MADE: 15-AUG-13
Fort Lauderdale FL 33309          510(k) STATEMENT

DEVICE: AMECO SHEATH INTRODUCER
AMECO MEDICAL INDUSTRIES          510(k) NO: K131144(TRADITIONAL)
ATTN: RAYMOND J KELLY             PHONE NO : 203 400 7566   
57 LAZY BROOK RD                  SE DECISION MADE: 15-AUG-13
MONROE CT 06468                   510(k) STATEMENT

DEVICE: SYMBIA
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K131634(TRADITIONAL)
ATTN: ELAINE  CHANG               PHONE NO : 865 218 2873   
810 INNOVATION DRIVE              SE DECISION MADE: 16-AUG-13
KNOXVILLE TN 37932 2751           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JIAJIAN CMN STIMULATOR
WUXI JIAJIAN MEDICAL INSTRUMENT CO510(k) NO: K130768(TRADITIONAL)
ATTN: DORIS  DONG                 PHONE NO : 86 21 31261348
ROOM 1706, NO.128 SONGLE RD SONGJISE DECISION MADE: 16-AUG-13
SHANGHAI    CH 201600             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)
ACTUATED MEDICAL, INC.            510(k) NO: K131052(TRADITIONAL)
ATTN: DEBORA  DEMERS, PH.D.       PHONE NO : 814 355 0003   
310 Rolling Ridge Dr              SE DECISION MADE: 16-AUG-13
Bellefonte PA 16823               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PERF-GEN PULSATILE PERFUSION SOLUTION
WATERS MEDICAL SYSTEMS, LLC       510(k) NO: K121736(TRADITIONAL)
ATTN: ROBERT  WARREN              PHONE NO : 800 426 9877   
2112 15TH ST. N.W.                SE DECISION MADE: 16-AUG-13
ROCHESTER MN 55901                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRS CRANIAL BONE VOID FILLER(TRS C-BVF)
TISSUE REGENERATION SYSTEMS, INC. 510(k) NO: K123633(TRADITIONAL)
ATTN: JIM  FITZSIMMONS            PHONE NO : 425 576 4032   
5400 CARILLON POINT               SE DECISION MADE: 16-AUG-13
KIRKLAND WA 98033                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDO A CLASS
SAEYANG MICROTECH CO., LTD        510(k) NO: K123582(TRADITIONAL)
ATTN: JIGAR  SHAH                 PHONE NO : 516 482 9001   
55 NORTHERN BLVD                  SE DECISION MADE: 16-AUG-13
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUICKIE & ZIPPIE SERIES
SUNRISE MEDICAL                   510(k) NO: K123975(TRADITIONAL)
ATTN: LAURIE  ROBERTS             PHONE NO : 559 348 2572   
2842 BUSINESS PARK AVE.           SE DECISION MADE: 16-AUG-13
FRESNO CA 93727 1328              510(k) STATEMENT

DEVICE: VERIFY PROCESS INDICATOR FOR RELIANCE EPS
STERIS CORPORATION                510(k) NO: K130160(TRADITIONAL)
ATTN: MARCIA L BENEDICT           PHONE NO : 440 392 7063   
5960 HEISLEY ROAD                 SE DECISION MADE: 16-AUG-13
MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COVAGEN
COVALON TECHNOLOGIES LTD.         510(k) NO: K123756(TRADITIONAL)
ATTN: CHRISTOPHER  FREDRIC        PHONE NO : 905 568840 0
405 BRITANNIA ROAD EAST SUITE 106 SE DECISION MADE: 16-AUG-13
MISSISSAUGA, ONTARIO    CA L4Z 3E6510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMARTFLOW CATHETER
MRI INTERVENTIONS, INC.           510(k) NO: K123605(TRADITIONAL)
ATTN: EDWARD F WADDELL            PHONE NO : 949 900 6833   
5 Musick                          SE DECISION MADE: 16-AUG-13
Irvine CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABG III MONOLITHIC HIP STEM
HOWMEDICA OSTEONICS CORP          510(k) NO: K123604(TRADITIONAL)
ATTN: COLLEEN  BURDEL             PHONE NO : 201 831 5969   
325 CORPORATE DR.                 SE DECISION MADE: 16-AUG-13
MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUATTRO GL SUTURE ANCHOR
CAYENNE MEDICAL, INC.             510(k) NO: K131325(TRADITIONAL)
ATTN: KERESHMEH  SHAHRIARI        PHONE NO : 480 502 3661   
16597 N. 92ND STREET SUITE 101    SE DECISION MADE: 16-AUG-13
SCOTTSDALE AZ 85260               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEWA SKIN THERAPY SYSTEM
ENDYMION MEDICAL LTD              510(k) NO: K130793(TRADITIONAL)
ATTN: YORAM  LEVY                 PHONE NO : 972 463091 00
31 HAAVODA ST.                    SE DECISION MADE: 16-AUG-13
BINYAMINA    IS 30500             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERMITTENT PNEUMATIC COMPRESSION DEVICE
DALIAN LABTEK SCIENCE & DEVELOPMEN510(k) NO: K123830(TRADITIONAL)
ATTN: DORIS  DONG                 PHONE NO : 86 213126 1348
RM 1706 YUESHA, NO. 128 SONGLE RD,SE DECISION MADE: 16-AUG-13
SHANGHAI    CH 201600             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: D-LUX
DIADENT GROUP INTERNATIONAL       510(k) NO: K130163(TRADITIONAL)
ATTN: GIL  JUN, HONG              PHONE NO : 82 43 2662315
626, YEONJE-RI, GANGOE-MYEON CHEONSE DECISION MADE: 16-AUG-13
CHUNGCHEONG BUK-DO    KS 363-951  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET
MEDICAL COMPONENTS INC            510(k) NO: K131687(TRADITIONAL)
ATTN: JESSICA  LEO                PHONE NO : 215 256 4201   
1499 DELP DRIVE                   SE DECISION MADE: 16-AUG-13
HARLEYSVILLE PA 19438             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
COOK, INC.                        510(k) NO: K132334(SPECIAL)
ATTN: SEAN  SPENCE                PHONE NO : 812 335 3575   
750 DANIELS WAY                   SE DECISION MADE: 16-AUG-13
Blmgtn IN 47404                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTELLIVUE PATIENT MONITOR
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K131829(SPECIAL)
ATTN: HERBERT  VAN DYK            PHONE NO : 49 7031 4631734
HEWLETT-PACKARD STR.2             SE DECISION MADE: 16-AUG-13
BOEBLINGEN    GM D 71034          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDO E CLASS
SAEYANG MICROTECH CO., LTD        510(k) NO: K123608(TRADITIONAL)
ATTN: JIGAR  SHAH                 PHONE NO : 516 482 9001   
55 NORTHERN BLVD                  SE DECISION MADE: 16-AUG-13
GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXERA 2 ACCESS SYSTEM
ARSTASIS, INC.                    510(k) NO: K132263(SPECIAL)
ATTN: DEBRA  COGAN                PHONE NO : 650 261 8073   
740 BAY RD                        SE DECISION MADE: 19-AUG-13
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
MICROGENICS CORP.                 510(k) NO: K122766(TRADITIONAL)
ATTN: KAREN  LEE                  PHONE NO : 510 979 5000   
46360 FREMONT BLVD                SE DECISION MADE: 20-AUG-13
FREMONT CA 94538                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTILINK HYBRID ABUTMENT CEMENT
IVOCLAR VIVADENT AG               510(k) NO: K130436(TRADITIONAL)
ATTN: DONNA MARIE  HARTNETT       PHONE NO : 716 691 2260   
175 PINEVIEW DR.                  SE DECISION MADE: 20-AUG-13
AMHERST NY 14228                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STAXX IBL SYSTEM
SPINE WAVE, INC.                  510(k) NO: K131071(TRADITIONAL)
ATTN: ROAIDA  RIZKALLAH           PHONE NO : 203 944 9494   
3 ENTERPRISE DR. SUITE 210        SE DECISION MADE: 20-AUG-13
SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KIMGUARD ONE STEP STERILIZATION WRAP
KIMBERLY-CLARK HEALTH CARE        510(k) NO: K113806(TRADITIONAL)
ATTN: CHRISTOPHER B SWANSON       PHONE NO : 949 789 8620   
33 TECHNOLOGY DRIVE               SE DECISION MADE: 20-AUG-13
IRVINE CA 92618                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURESUBTRACTION ORTHO
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K130960(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714 669 7808   
2441 MICHELLE DRIVE               SE DECISION MADE: 20-AUG-13
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAS PSI SHOULDER
ZIMMER CAS                        510(k) NO: K131129(TRADITIONAL)
ATTN: JASON  HECKAMAN             PHONE NO : 574 371 8675   
1800 WEST CENTER STREET           SE DECISION MADE: 20-AUG-13
WARSAW IN 46580                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K130749(TRADITIONAL)
ATTN: NADIA  SOOKDEO              PHONE NO : 610 448 4918   
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 20-AUG-13
MALVERN PA 19355                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERICAN CANNULA
B. BRAUN MEDICAL, INC.            510(k) NO: K131842(TRADITIONAL)
ATTN: KIMBERLY  SMITH             PHONE NO : 610 596 2326   
901 MARCON BLVD.                  SE DECISION MADE: 20-AUG-13
ALLENTOWN PA 18109 9341           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GUARDIAN URETHRAL SHEATH
SOLACE THERAPEUTICS               510(k) NO: K131803(SPECIAL)
ATTN: WILLIAM  GRUBER             PHONE NO : 508 283 1200   
135 Newbury St                    SE DECISION MADE: 20-AUG-13
Framingham MA 01701               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE
KIMBERLY-CLARK CORP.              510(k) NO: K131254(TRADITIONAL)
ATTN: MARCIA  JOHNSON             PHONE NO : 770 587 8566   
1400 HOLCOMB BRIDGE RD.           SE DECISION MADE: 20-AUG-13
ROSWELL GA 30076                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM
SAMSUNG MEDISON CO., LTD          510(k) NO: K132228(TRADITIONAL)
ATTN: KYEONG-MI  PARK             PHONE NO : 822 21 941373
42, TEHERAN-RO 108-GIL GANGNAM-GU SE DECISION MADE: 20-AUG-13
SEOUL    KS                       510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: MAPCHECK2, ARCCHECK
SUN NUCLEAR CORPORATION           510(k) NO: K131466(TRADITIONAL)
ATTN: JEFF  KAPATOES              PHONE NO : 321 259 6862   
3275 Suntree Blvd                 SE DECISION MADE: 20-AUG-13
Melbourne FL 32940                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION
ACCEL SPINE                       510(k) NO: K132365(SPECIAL)
ATTN: AEKTA  PATEL                PHONE NO : 214 545 5833   
14901 QUORUM DR. STE. 125         SE DECISION MADE: 20-AUG-13
DALLAS TX 75254                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PAGODA PEDICLE SCREW SYSTEM
ORTHO DEVELOPMENT CORP.           510(k) NO: K131785(TRADITIONAL)
ATTN: TOM  HAUETER                PHONE NO : 801 553 9991   
12187 SOUTH BUSINESS PARK DR.     SE DECISION MADE: 20-AUG-13
DRAPER UT 84020                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR
PHYSIO-CONTROL, INC.              510(k) NO: K130454(TRADITIONAL)
ATTN: MICHELLE  ACKERMANN         PHONE NO : 425 867 4744   
11811 WILLOWS ROAD NORTHEAST P.O. SE DECISION MADE: 21-AUG-13
REDMOND WA 98073 9706             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORVIEW
MARREK, INC                       510(k) NO: K131158(TRADITIONAL)
ATTN: JEREMY M FOTHERINGHAM       PHONE NO : 801 870 4323   
3293 NIBLICK DRIVE                SE DECISION MADE: 21-AUG-13
PARK CITY UT 84098                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SWING-OFF SCREW
ADVANCED INTERVENTIONAL TECHNOLOGY510(k) NO: K130627(TRADITIONAL)
ATTN: EDUARDO  MARCH              PHONE NO : 240 506 3212   
7000 CASHELL MANOR CT             SE DECISION MADE: 21-AUG-13
DERWOOD MD 20855                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
PHILIPS ULTRASOUND, INC.          510(k) NO: K132304(TRADITIONAL)
ATTN: JESSICA  STENBERG           PHONE NO : 425 487 7371   
22100 BOTHELL EVERETT HWY.        SE DECISION MADE: 21-AUG-13
BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: JUSHA-M32 MEDICAL DISPLAY
NANJING JUSHA DISPLAY TECHNOLOGY C510(k) NO: K131391(TRADITIONAL)
ATTN: MIKE  GU                    PHONE NO : 86 20 62321333
7TH FLOOR, 982. CONGYUN RD. BAIYUNSE DECISION MADE: 21-AUG-13
GUANGZHOU, GUANGDONG    CH CH51042510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3DVH
SUN NUCLEAR CORPORATION           510(k) NO: K131862(TRADITIONAL)
ATTN: JEFF  KAPATOES              PHONE NO : 321 259 6862   
3275 Suntree Blvd                 SE DECISION MADE: 21-AUG-13
Melbourne FL 32940                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE NEUTRAL ELECTRODE GP202
CATHAY MANUFACTURING CORP.        510(k) NO: K130027(TRADITIONAL)
ATTN: ZHANG  HUI                  PHONE NO : 
NO. 328, XISHE ROAD, MAOGANG TOWN,SE DECISION MADE: 22-AUG-13
SHANGHAI    CH 201607             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AERODR SYSTEM WITH P-31
KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K130936(TRADITIONAL)
ATTN: RUSSEL  MUNVES              PHONE NO : 212 497 8208   
140 EAST 45TH ST., 25TH FLOOR TWO SE DECISION MADE: 22-AUG-13
NEW YORK NY 10017                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURGIQUEST AIRSEAL IFS
SURGIQUEST, INC.                  510(k) NO: K132169(SPECIAL)
ATTN: DANIEL  DONOVAN             PHONE NO : 203 799 2400   
333 Quarry Rd                     SE DECISION MADE: 22-AUG-13
Milford CT 06460                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIM
SIMAVITA PTY LIMITED              510(k) NO: K130951(TRADITIONAL)
ATTN: JOHN J SMITH, MD,JD         PHONE NO : 202 637 5600   
555 13TH ST. NW                   SE DECISION MADE: 22-AUG-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROGIGY SUPPORT CATHETER
RADIUS MEDICAL, LLC               510(k) NO: K130714(ABBREVIATED)
ATTN: RICHARD  DEMELLO            PHONE NO : 978 263 4466   
577 Main St Ste 360               SE DECISION MADE: 22-AUG-13
Hudson MA 01749                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE)
ELIMEDICAL DEVICES (FUJIAN) INC.  510(k) NO: K130301(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 237-023                  SE DECISION MADE: 22-AUG-13
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS
MERZ DENTAL GMBH                  510(k) NO: K130076(TRADITIONAL)
ATTN:                             PHONE NO : 
5616 MARIOLA PL NE                SE DECISION MADE: 22-AUG-13
ALBUQUERQUE NM 87111              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GMK FULL PE TIBIAL COMPONENTS
MEDACTA INTERNATIONAL             510(k) NO: K131310(TRADITIONAL)
ATTN: ADAM  GROSS                 PHONE NO : 805 322 3289   
4725 CALLE QUETZAL, UNIT B        SE DECISION MADE: 22-AUG-13
CAMARILLO CA 93012                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000
MESPERE LIFESCIENCES INC.         510(k) NO: K131085(TRADITIONAL)
ATTN: HELEN  TAN                  PHONE NO : 519 884 7575 X01
180 FROBISHER DR, UNIT 1C         SE DECISION MADE: 22-AUG-13
WATERLOO, ON    CA N2V 2A2        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)
HOLOGIC, INC.                     510(k) NO: K131581(SPECIAL)
ATTN: SARAH  FAIRFIELD            PHONE NO : 508 263 8857   
250 CAMPUS DRIVE                  SE DECISION MADE: 22-AUG-13
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYMBOTEX(TM) COMPOSITE MESH
SOFRADIM PRODUCTION               510(k) NO: K131969(TRADITIONAL)
ATTN: CLARE  SANTULLI             PHONE NO : 203 492 7635   
60 MIDDLETOWN AVENUE              SE DECISION MADE: 22-AUG-13
NORTH HAVEN CT 06473              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRYOBALLOON FOCAL ABLATION SYSTEM
C2 THERAPEUTICS                   510(k) NO: K131523(SPECIAL)
ATTN: PETER  GARCIA-MEZA          PHONE NO : 650 521 5304   
303 CONVENTION WAY SUITE 1        SE DECISION MADE: 22-AUG-13
REDWOOD CITY CA 94063             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MOUNTAINEER OCT SPINAL SYSTEM
MEDOS INTERNATIONAL SARL          510(k) NO: K132332(SPECIAL)
ATTN: KIRSTEN  LEHMULLER          PHONE NO : 508 828 3291   
325 PARAMOUNT DRIVE               SE DECISION MADE: 22-AUG-13
RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS
3B MEDICAL, INC                   510(k) NO: K131707(SPECIAL)
ATTN: ALEX  LUCIO                 PHONE NO : 863 226 6285   
21301 HWY 27 N                    SE DECISION MADE: 22-AUG-13
Lake Wales FL 33859               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WET PLATINUM PERSONAL LUBRICANT
TRIGG LABORATORIES, INC.          510(k) NO: K130012(TRADITIONAL)
ATTN: ERNIE  JOHNSON              PHONE NO : 800 248 4811   
28650 Braxton Ave                 SE DECISION MADE: 22-AUG-13
Valencia CA 91355                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)
HOLOGIC, INC.                     510(k) NO: K131736(SPECIAL)
ATTN: SARAH  FAIRFIELD            PHONE NO : 508 263 8857   
250 CAMPUS DRIVE                  SE DECISION MADE: 22-AUG-13
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDERED VINYL EXAMINATION GLOVES
WANG TONG XINGHUA CO., LTD        510(k) NO: K122100(TRADITIONAL)
ATTN: GUO  YANG                   PHONE NO : 865 238 3495629
WEST OF GUO JING ROAD ECONOMIC DEVSE DECISION MADE: 22-AUG-13
XINGHUA    CH 225700              510(k) STATEMENT

DEVICE: GIO DIGITAL PRESSURE GUAGES
GALEMED CORP.                     510(k) NO: K122627(TRADITIONAL)
ATTN: TOM  SHANKS                 PHONE NO : 951 506 2674   
29201 VIA NORTE                   SE DECISION MADE: 22-AUG-13
TEMECULA CA 92591                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PALTOP DENTAL IMPLANT - STERILE ACCESSORIES
PALTOP ADVANCED DENTAL SOLUTIONS L510(k) NO: K131451(SPECIAL)
ATTN: TAL  HAMMER-TOPAZ           PHONE NO : 972 4 6271711
5 HASHITA STREET                  SE DECISION MADE: 22-AUG-13
CAESAREA    IS IS                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLOWER SMALL AND MEDIUM IMPLANT SET
FLOWER ORTHOPEDICS CORPORATION    510(k) NO: K131657(SPECIAL)
ATTN: JANICE M HOGAN              PHONE NO : 267 675 4611   
1835 MARKET ST, 29TH FLOOR        SE DECISION MADE: 22-AUG-13
PHILADELPHIA PA 19103             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND
ARTHROCARE CORPORATION            510(k) NO: K132099(TRADITIONAL)
ATTN: SHIRLEY  HYINK              PHONE NO : 512 358 5771   
7000 WEST WILLIAM CANNON DRIVE    SE DECISION MADE: 22-AUG-13
AUSTIN TX 78735 0000              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSUFLOW SYNERGY XL PORT
LEXION MEDICAL, LLC.              510(k) NO: K132204(SPECIAL)
ATTN: BERNARD  HORWATH            PHONE NO : 651 231 1761   
4486 TIMBERLINE CT                SE DECISION MADE: 22-AUG-13
VADNAIS HEIGHTS MN 55127          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAS FLUALERT A & B, SAS INFLUENZA A TEST
SA SCIENTIFIC LTD.                510(k) NO: K132352(SPECIAL)
ATTN: NELSON  TORRES              PHONE NO : 210 699 8800   
4919 GOLDEN QUAIL                 SE DECISION MADE: 22-AUG-13
SAN ANTONIO TX 78240              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVENIR CEMENTED HIP STEM
ZIMMER GMBH                       510(k) NO: K131884(TRADITIONAL)
ATTN: KAREN  O'LEARY              PHONE NO : 574 371 8515   
P.O. BOX 708                      SE DECISION MADE: 22-AUG-13
WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL
KURARAY NORITAKE DENTAL INC.      510(k) NO: K131432(TRADITIONAL)
ATTN: MICHIO  TAKIGAWA            PHONE NO : 81 3 67011706
OTE CENTER BLDG 7F 1-1-3, OTEMACHISE DECISION MADE: 22-AUG-13
CHIYODA-KU    JA 100-0004         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEGACY3 6MM LENGTH IMPLANTS
IMPLANT DIRECT SYBRON MANUFACTURIN510(k) NO: K131097(TRADITIONAL)
ATTN: INES  ARAVENA               PHONE NO : 818 444 3300   
27030 Malibu Hills Rd             SE DECISION MADE: 22-AUG-13
Calabasas CA 91301                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRE-FORMED GUIDEWIRES
LAKE REGION MEDICAL, INC.         510(k) NO: K130798(TRADITIONAL)
ATTN: MATHEW  PEXA                PHONE NO : 952 448 5111   
340 LAKE HAZELTINE DR.            SE DECISION MADE: 23-AUG-13
CHASKA MN 55318                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VANISHPOINT BLOOD COLLECTION SET
RETRACTABLE TECHNOLOGIES, INC.    510(k) NO: K122355(TRADITIONAL)
ATTN: RHONDA  WELLS               PHONE NO : 972 294 1010   
511 Lobo Ln                       SE DECISION MADE: 23-AUG-13
Little Elm TX 75068               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUTTER BIPOLAR FORCEPS - SUPERGLISS
SUTTER MEDIZINTECHNIK GMBH        510(k) NO: K131012(TRADITIONAL)
ATTN: SABINE  KLUGBAUER           PHONE NO : 49 761 5155114
TULLASTRASSE 87                   SE DECISION MADE: 23-AUG-13
FREIBURG    GM D-79108            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TEMPUS(TM) CERVICAL PLATE SYSTEM
NEUROSTRUCTURES, LLC              510(k) NO: K131374(TRADITIONAL)
ATTN: MEREDITH  MAY               PHONE NO : 719 337 7579   
4628 NORTHPARK DR                 SE DECISION MADE: 23-AUG-13
COLORADO SPRINGS CO 80918         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGSTIM DOUBLE 70-2 COIL
THE MAGSTIM COMPANY LTD.          510(k) NO: K130403(SPECIAL)
ATTN: J. P OUELLETTE              PHONE NO : 978 682 8085   
101 MILK ST.                      SE DECISION MADE: 23-AUG-13
METHUEN MA 01844                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER
COLTENE/WHALEDENT                 510(k) NO: K130137(TRADITIONAL)
ATTN: EDWARD A KROLL              PHONE NO : 440 546 9810   
5905 LAWN LANE                    SE DECISION MADE: 23-AUG-13
CLEVELAND OH 44141                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIODAY
GETEMED MEDIZIN- UND INFORMATIONST510(k) NO: K130516(TRADITIONAL)
ATTN: BERT  SCHADOW               PHONE NO : 49 332839 4299
ODERSTR. 77                       SE DECISION MADE: 23-AUG-13
TELTOW, BRANDENBURG    GM 14513   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCUSONIC ADVANTAGE
METRON MEDICAL AUSTRALIA PTY LTD  510(k) NO: K124010(TRADITIONAL)
ATTN: DAVID  MITCHELL             PHONE NO : 61 3 97751234
57 ASTER AVE.                     SE DECISION MADE: 23-AUG-13
CARRUM DOWNS, VICTORIA    AS 3201 510(k) STATEMENT

DEVICE: GYNECARE TVT EXACT CONTINENCE SYSTEM
ETHICON, INC.                     510(k) NO: K132054(SPECIAL)
ATTN: SUSAN  LIN                  PHONE NO : 908 218 2256   
P.O. BOX 151 ROUTE 22 WEST        SE DECISION MADE: 23-AUG-13
SOMERVILLE NJ 08876 0151          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM
MEDYSSEY USA, INC.                510(k) NO: K131878(TRADITIONAL)
ATTN: RICH  JANSEN                PHONE NO : 612 281 5505   
13540 GUILD AVE                   SE DECISION MADE: 23-AUG-13
APPLE VALLEY MN 55124             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL
BIOTRONIK, INC.                   510(k) NO: K131978(SPECIAL)
ATTN: JON  BRUMBAUGH              PHONE NO : 888 345 0374   
6024 JEAN ROAD                    SE DECISION MADE: 23-AUG-13
LAKE OSWEGO OR 97035              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
SURGICAL SPECIALTIES CORPORATION D510(k) NO: K132268(SPECIAL)
ATTN: KIRSTEN  STOWELL            PHONE NO : 610 404 3367   
100 DENNIS DRIVE                  SE DECISION MADE: 23-AUG-13
READING PA 19606                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOBAND LIGATOR
ENDOCHOICE, INC.                  510(k) NO: K132535(SPECIAL)
ATTN: DANIEL  HOEFER              PHONE NO : 678 708 4743   
11810 WILLS ROAD                  SE DECISION MADE: 23-AUG-13
ALPHARETTA GA 30009               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEVIIN SURFACE REPLACEMENT SHOULDER
INGEN ORTHOPEDICS LLC             510(k) NO: K130635(TRADITIONAL)
ATTN: PERRY A GEREMAKIS           PHONE NO : 609 409 3316   
2650 US HIGHWAY 130               SE DECISION MADE: 26-AUG-13
CRANBURY NJ 08512                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ITERO SOFTWARE
CADENT, LTD. AN ALIGN TECHNOLOGY C510(k) NO: K131101(TRADITIONAL)
ATTN: MANAS M LELE                PHONE NO : 408 789 1550   
2560 ORCHARD PKWY                 SE DECISION MADE: 26-AUG-13
SAN JOSE CA 95131                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PREMIER CERAMIC PRIMER
PREMIER DENTAL PRODUCTS CO.       510(k) NO: K131212(TRADITIONAL)
ATTN: VINCENT  D'ALESSANDRO       PHONE NO : 610 239 6000   
1710 ROMANO DR.                   SE DECISION MADE: 26-AUG-13
PLYMOUTH MEETING PA 19462         510(k) STATEMENT

DEVICE: INTERFORM INTERBODY CAGE SYSTEM
NEXT ORTHOSURGICAL                510(k) NO: K131082(TRADITIONAL)
ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 26-AUG-13
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIRST RESPONSE EARLY RESULT PREGNANCY TEST
CHURCH & DWIGHT CO., INC.         510(k) NO: K123436(TRADITIONAL)
ATTN: JOSEPH  CICCONE             PHONE NO : 609 806 1994   
469 NORTH HARRISON STREET         SE DECISION MADE: 26-AUG-13
PRINCETON NJ 08543                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATG/SM-OSA APPLIANCES
SELANE PRODUCTS, INC.             510(k) NO: K130130(TRADITIONAL)
ATTN: CAROLYN  PRIMUS             PHONE NO : 941 753 9737   
7046 OWL'S NEST TERRACE           SE DECISION MADE: 26-AUG-13
BRADENTON FL 34203                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRODESSE PROFAST+ ASSAY
GEN-PROBE PRODESSE, INC.          510(k) NO: K132237(SPECIAL)
ATTN: EMILY  ZIEGLER              PHONE NO : 262 953 8426   
20925 CROSSROADS CIRCLE           SE DECISION MADE: 26-AUG-13
Waukesha WI 53186                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROPARAFLU+ ASSAY
GEN-PROBE PRODESSE, INC.          510(k) NO: K132238(SPECIAL)
ATTN: EMILY  ZIEGLER              PHONE NO : 262 953 8426   
20925 CROSSROADS CIRCLE           SE DECISION MADE: 26-AUG-13
Waukesha WI 53186                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOGIQ S8
GE HEALTHCARE                     510(k) NO: K131527(TRADITIONAL)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721 4214   
9900 INNOVATION DRIVE             SE DECISION MADE: 26-AUG-13
WAUWATOSA WI 53233                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES
ENCISION, INC.                    510(k) NO: K131949(TRADITIONAL)
ATTN: JIM  LEWIS                  PHONE NO : 303 444 2600   
6797 WINCHESTER CIR.              SE DECISION MADE: 26-AUG-13
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT
PALTOP ADVANCED DENTAL SOLUTIONS L510(k) NO: K130462(TRADITIONAL)
ATTN: TAL  HAMMER-TOPAZ           PHONE NO : 972 462 71711
5 HASHITA STREET PO BOX 3568      SE DECISION MADE: 27-AUG-13
CAESAREA    IS IS                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMARTCOAT 2.5% NAF VARNISH
ELEVATE ORAL CARE                 510(k) NO: K131376(TRADITIONAL)
ATTN: STEVE  PARDUE               PHONE NO : 877 866 9113   
346 PIKE ROAD SUITE 5             SE DECISION MADE: 27-AUG-13
WEST PALM BEACH FL 33411          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TIPI OTC
CONTIPI LTD.                      510(k) NO: K131198(TRADITIONAL)
ATTN: JONATHAN  KAHAN             PHONE NO : 202 637 5794   
555 THIRTEENTH ST NW              SE DECISION MADE: 27-AUG-13
WASHINGTON DC 20004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID
KURARAY NORITAKE DENTAL INC.      510(k) NO: K131068(TRADITIONAL)
ATTN: MICHIO  TAKIGAWA            PHONE NO : 81 3 6711706
OTE CENTER BLDG 7F 1-1-3, OTEMACHISE DECISION MADE: 27-AUG-13
CHIYODA-KU    JA 100-0004         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
COVIDIEN                          510(k) NO: K132360(SPECIAL)
ATTN: ASHLEY  GONCALO             PHONE NO : 508 452 4518   
15 HAMPSHIRE STREET               SE DECISION MADE: 27-AUG-13
MANSFIELD MA 02048                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET
INNOVATIVE MEDICAL TECHNOLOGIES, I510(k) NO: K123987(TRADITIONAL)
ATTN: BRAD  BROWN                 PHONE NO : 913 515 0917   
15059 CEDAR ST.                   SE DECISION MADE: 27-AUG-13
LEAWOOD KS 66224                  510(k) STATEMENT

DEVICE: EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS
DENTAL MORELLI                    510(k) NO: K131197(TRADITIONAL)
ATTN: TARA  CONRAD                PHONE NO : 305 377 0077   
18851 NE 29TH AVE 720             SE DECISION MADE: 27-AUG-13
AVENTURA FL 33180                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZRP
APEX DENTAL MATERIALS, INC.       510(k) NO: K131049(TRADITIONAL)
ATTN: CHRIS  KULTON               PHONE NO : 847 719 1133   
330 TELSER ROAD                   SE DECISION MADE: 27-AUG-13
LAKE ZURICH IL 60047              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NT1D VITAL SIGNS MONITOR
NEW TECH, INC.                    510(k) NO: K123797(TRADITIONAL)
ATTN: DIANA  HONG                 PHONE NO : 86 21 22815850
P.O. BOX 237-023                  SE DECISION MADE: 27-AUG-13
SHANGHAI    CH 200237             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ILLUMASK ACNE LIGHT THERAPY MASK
LA LUMIERE, LLC                   510(k) NO: K123999(TRADITIONAL)
ATTN: ROBERT  SEIPLE, RAC         PHONE NO : 512 327 9997   
611 W. 5TH ST.                    SE DECISION MADE: 28-AUG-13
AUSTIN TX 78701                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONICISION STERILIZATION TRAY
COVIDIEN, FORMERLY VALLEYLAB, A DI510(k) NO: K131170(TRADITIONAL)
ATTN: DAVID  HORTON               PHONE NO : 303 530 6391   
5920 Longbow Dr                   SE DECISION MADE: 28-AUG-13
BOULDER CO 80301                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SELF-COMPRESSIVE SCREW
NEOSTEO                           510(k) NO: K131471(TRADITIONAL)
ATTN: JD  WEBB                    PHONE NO : 512 388 0199   
1001 OAKWOOD BLVD                 SE DECISION MADE: 28-AUG-13
ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESTORE BUNION CORRECTION SYSTEM
NEXTREMITY SOLUTIONS              510(k) NO: K131061(TRADITIONAL)
ATTN: JANET  WEBB                 PHONE NO : 312 643 1306   
60 Broad St Ste 102               SE DECISION MADE: 28-AUG-13
Red Bank NJ 07701                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEVIIN FRACTURE SHOULDER
INGEN ORTHOPEDICS LLC             510(k) NO: K131277(TRADITIONAL)
ATTN: PERRY A GEREMAKIS           PHONE NO : 609 409 3316   
2650 US HIGHWAY 130               SE DECISION MADE: 28-AUG-13
CRANBURY NJ 08512                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLIGN
JILIN CORONADO MEDICAL LTD.       510(k) NO: K131124(TRADITIONAL)
ATTN: ERIC  CHIEN                 PHONE NO : 864 326352 9555
9 South-Western Circle Road FenmanSE DECISION MADE: 28-AUG-13
Jilin    CN 132016                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UGFT3; FHT7
MEDISIM LTD.                      510(k) NO: K131155(TRADITIONAL)
ATTN: MOSHE  YARDEN               PHONE NO : 972 2 5791921
G.G. COMMUNICATIONS CENTER NEVE IISE DECISION MADE: 28-AUG-13
JERUSALEM    IS 90850             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIORETEC ACTIVASCREW INTERFERENCE
BIORETEC LTD                      510(k) NO: K130716(TRADITIONAL)
ATTN: MARI  RUOTSALAINEN          PHONE NO : 358 207789 500
HERMIANKATU 22 MODULIGHT BLDG     SE DECISION MADE: 28-AUG-13
TAMPERE    FI FI-33720            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARESCAPE MONITOR B850
GE HEALTHCARE FINLAND OY          510(k) NO: K131414(TRADITIONAL)
ATTN: JOEL  KENT                  PHONE NO : 358 103941 1
KUORTANEENKATU 2                  SE DECISION MADE: 28-AUG-13
HELSINKI    FI FIN-00510          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400
BIOMONDE                          510(k) NO: K131221(TRADITIONAL)
ATTN: ROSINA  ROBINSION, RN, MED, PHONE NO : 508 316 7109   
62 FOREST STREET, STE 300         SE DECISION MADE: 28-AUG-13
MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDERED LATEX SURGEON'S GLOVE
SUZHOU COLOUR-WAY ENTERPRISE DEVEL510(k) NO: K121925(ABBREVIATED)
ATTN: ZHU  YINGQIU                PHONE NO : 865 126537 1793
83 CHANGPING ROAD, DONGQIAO INDUSTSE DECISION MADE: 28-AUG-13
SUZHOU, JIANGSU    CH 215152      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARESCAPE MONITOR B650
GE HEALTHCARE FINLAND OY          510(k) NO: K131223(TRADITIONAL)
ATTN: JOEL  KENT                  PHONE NO : 358 103941 1
KUORTANEENKATU 2                  SE DECISION MADE: 28-AUG-13
HELSINKI    FI FIN-00510          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIDCO CNAP MODULE
LIDCO LTD.                        510(k) NO: K131048(TRADITIONAL)
ATTN: GREGORY  SPELLER            PHONE NO : 44 207 7491500
16 ORSMAN RD.                     SE DECISION MADE: 28-AUG-13
LONDON    UK N15QJ                510(k) STATEMENT

DEVICE: STALIF X
CENTINEL SPINE INC.               510(k) NO: K130461(TRADITIONAL)
ATTN: JUSTIN  EGGLETON            PHONE NO : 202 552 5800   
31 H STREET NW 12TH FLOOR         SE DECISION MADE: 28-AUG-13
WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K131507(TRADITIONAL)
ATTN: CHARLEMAGNE  CHUA           PHONE NO : 714 669 7896   
2441 MICHELLE DRIVE               SE DECISION MADE: 28-AUG-13
TUSTIN CA 92780                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)
NIPRO MEDICAL CORPORATION         510(k) NO: K131641(TRADITIONAL)
ATTN: JESSICA  OSWALD-MCLEOD      PHONE NO : 305 599 7174   
3150 N.W. 107TH AVE.              SE DECISION MADE: 28-AUG-13
DORAL FL 33172                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DERMISEB CREAM
IGI LABORATORIES, INC.            510(k) NO: K123724(TRADITIONAL)
ATTN: FREDERICK  WEISS            PHONE NO : 856 697 1441   
105 LINCOLN AVE. P.O. BOX 687     SE DECISION MADE: 28-AUG-13
BUENA NJ 08310                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM
SENSUS HEALTHCARE                 510(k) NO: K131582(TRADITIONAL)
ATTN: KAL  FISHMAN                PHONE NO : 561 922 5808   
851 BROKEN SOUND PKWY NW #215     SE DECISION MADE: 28-AUG-13
BOCA RATON FL 33487               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUVASIVE DECADE LATERAL PLATE SYSTEM
NUVASIVE, INC.                    510(k) NO: K130868(TRADITIONAL)
ATTN: CYNTHIA  ADAMS              PHONE NO : 858 320 4549   
7475 LUSK BLVD                    SE DECISION MADE: 29-AUG-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDISIZE GOLD HEATER AND BOOSTER T-PIECE
MEDISIZE BV                       510(k) NO: K122885(TRADITIONAL)
ATTN: IFFAT  NOOR                 PHONE NO : 317 034 58570
PRINSESSEGRACHT 20                SE DECISION MADE: 29-AUG-13
THE HAGUE    NL 2514 AP           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CR 12-X DIGITIZER
AGFA HEALTHCARE N.V.              510(k) NO: K131408(SPECIAL)
ATTN: SHAEANN  CAVANAGH           PHONE NO : 864 421 1766   
10 S ACADEMY STREET               SE DECISION MADE: 29-AUG-13
GREENVILLE SC 29601               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENSITE VELOCITY SYSTEM
ST. JUDE MEDICAL                  510(k) NO: K130727(TRADITIONAL)
ATTN: DONNA R LUNAK               PHONE NO : 651 756 2944   
ONE ST. JUDE MEDICAL DRIVE        SE DECISION MADE: 29-AUG-13
ST. PAUL MN 55117                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASPIRON ACP SYSTEM
U & I CORPORATION                 510(k) NO: K131200(TRADITIONAL)
ATTN: GYEONG-JE  KWON             PHONE NO : 82 31852 0102 X610
20, SANDAN-RO, 76BEON-GIL (RD)    SE DECISION MADE: 29-AUG-13
UIJEONGBU-SI, GYEONGGI-DO    KS 48510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNGO CT PULMO 3D
SIEMENS MEDICAL SYSTEMS, INC.     510(k) NO: K123540(TRADITIONAL)
ATTN: KIMBERLY  MANGUM            PHONE NO : 610 448 4912   
51 VALLEY STREAM PARKWAY          SE DECISION MADE: 29-AUG-13
MALVERN PA 19355 1406             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARCHITECT IVANCOMYCIN
BIOKIT S.A.                       510(k) NO: K123947(TRADITIONAL)
ATTN: GUILLEM  ANGLERILL          PHONE NO : 34 938 609000
CAN MALE, S/N                     SE DECISION MADE: 29-AUG-13
LLISSA D'AMUNT, BARCELONA    SP 08510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONCIERGE GUIDING CATHETER
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K132409(SPECIAL)
ATTN: VICKI  GODWIN               PHONE NO : 801 208 4160   
1600 WEST MERIT PKWY.             SE DECISION MADE: 29-AUG-13
SOUTH JORDAN UT 84095             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MZ1000
CAREFUSION                        510(k) NO: K132413(TRADITIONAL)
ATTN: MICHELLE J BADAL, RAC       PHONE NO : 858 617 5925   
10020 PACIFIC MESA BLVD           SE DECISION MADE: 29-AUG-13
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ENDOWRIST ONE VESSEL SEALER
INTUITIVE SURGICAL, INC.          510(k) NO: K130266(TRADITIONAL)
ATTN: CRYSTAL  ONG                PHONE NO : 408 523 8636   
1266 KIFER RD                     SE DECISION MADE: 29-AUG-13
SUNNYVALE CA 94086                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMNIPOD INSULIN MANAGEMENT SYSTEM
INSULET CORPORATION               510(k) NO: K131294(TRADITIONAL)
ATTN: TARA N TURNEY               PHONE NO : 781 457 5234   
9 OAK PARK DR.                    SE DECISION MADE: 29-AUG-13
BEDFORD MA 01730                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAVEN PRO
NSEQUENCE                         510(k) NO: K130242(TRADITIONAL)
ATTN: RHONDA  ALEXANDER, MS, MPA  PHONE NO : 757 224 0177   
144 RESEARCH DRIVE                SE DECISION MADE: 29-AUG-13
HAMPTON VA 23666                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EZ3D-I, E3
EWOO SOFT CO., LTD                510(k) NO: K131616(TRADITIONAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
12946 KIMBERLEY LN                SE DECISION MADE: 29-AUG-13
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MD242C2 24" DIAGNOSTIC IMAGING LCD MONITOR
NED DISPLAY SOLUTIONS LTD.        510(k) NO: K132587(TRADITIONAL)
ATTN: TONY  HSU                   PHONE NO : 
4-28, MITA 1-CHOME, MINATO-KU     SE DECISION MADE: 29-AUG-13
TOKYO    JA                       510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: EZDENTI-I; E2; PRORA VIEW
EWOO SOFT CO., LTD                510(k) NO: K131594(TRADITIONAL)
ATTN: DAVE  KIM                   PHONE NO : 713 467 2607   
12946 KIMBERLEY LN                SE DECISION MADE: 29-AUG-13
HOUSTON TX 77079                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRESENIUS DRY ACID DISSOLUTION UNITS
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K131611(TRADITIONAL)
ATTN: DENISE  OPPERMANN           PHONE NO : 781 699 4479   
920 WINTER ST                     SE DECISION MADE: 29-AUG-13
WALTHAM MA 02451                  510(k) STATEMENT

DEVICE: ROTATION MEDICAL BONE STAPLE (RMB STAPLE)
ROTATION MEDICAL, INC.            510(k) NO: K131635(TRADITIONAL)
ATTN: GAIL  SCHROEDER             PHONE NO : 763 746 7521   
15350 25TH AVENUE N SUITE 100     SE DECISION MADE: 29-AUG-13
PLYMOUTH MN 55447                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMNI-VUE 2 SYSTEM
GENESIS DIGITAL IMAGING, INC.     510(k) NO: K130374(SPECIAL)
ATTN: CARL  ALLETTO               PHONE NO : 469 684 1980   
1600 MANCHESTER WAY               SE DECISION MADE: 29-AUG-13
CORINTH TX 76210                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EVIS EXERA III VIDEO SYSTEM
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K131780(SPECIAL)
ATTN: DAPHNEY  GERMAIN-KOLAWOLE   PHONE NO : 484 896 5691   
3500 CORPORATE PARKWAY            SE DECISION MADE: 29-AUG-13
CENTER VALLEY PA 18034 0610       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM
COVIDIEN                          510(k) NO: K131614(TRADITIONAL)
ATTN: DANIEL  CAMPION             PHONE NO : 508 452 4135   
15 HAMPSHIRE STREET               SE DECISION MADE: 29-AUG-13
MANSFIELD MA 02048                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM
ZIMMER SPINE, INC.                510(k) NO: K132012(TRADITIONAL)
ATTN: JONATHAN  GILBERT           PHONE NO : 952 830 6385   
7375 BUSH LAKE RD.                SE DECISION MADE: 29-AUG-13
MINNEAPOLIS MN 55439              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITAL SIGNS MONITOR
EDAN INSTRUMENTS, INC.            510(k) NO: K131818(SPECIAL)
ATTN: QUEENA  CHEN                PHONE NO : 867 55 26858736
EQUIPMENTS PARK, NANHAI RD 1019 NOSE DECISION MADE: 30-AUG-13
SHENZHEN    CH 518067             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UTF STEM-REDUCED, ADDITIONAL SIZES
UNITED ORTHOPEDIC CORPORATION     510(k) NO: K132207(SPECIAL)
ATTN: FANG-YUAN  HO               PHONE NO : 886 357733 51
NO 57, PARK AVE 2, SCIENCE PARK   SE DECISION MADE: 30-AUG-13
HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUS (STENFILCON A) CONTACT LENS
COOPERVISION, INC.                510(k) NO: K131378(TRADITIONAL)
ATTN: ANNETTE  NELSON             PHONE NO : 925 621 2453   
6150 STONERIDGE MALL ROAD SUITE 37SE DECISION MADE: 30-AUG-13
PLEASANTON CA 94588               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0
ADVANCED PLANIMETRIC SERVICES, LLC510(k) NO: K130165(TRADITIONAL)
ATTN: MARTIN  WENDELKEN           PHONE NO : 646 220 1745   
610 BOULEVARD                     SE DECISION MADE: 30-AUG-13
ELMWOOD PARK NJ 07407             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS
BIOLOGICS CONSULTING GROUP        510(k) NO: K124044(TRADITIONAL)
ATTN: CALLEY  HERZOG              PHONE NO : 720 883 3633   
400 N. WASHINGTON STREET SUITE 100SE DECISION MADE: 30-AUG-13
ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS
JIANGSU HORIEN CONTACT LENS CO., L510(k) NO: K130931(TRADITIONAL)
ATTN: JENNIFER  REICH             PHONE NO : 928 773 6340   
2904 N. BOLDT DRIVE               SE DECISION MADE: 30-AUG-13
FLAGSTAFF AZ 86001                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SWIP
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K131241(TRADITIONAL)
ATTN: SUSAN  QUICK                PHONE NO : 440 483 2291   
595 MINER RD                      SE DECISION MADE: 30-AUG-13
CLEVELAND OH 44143                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MRI PATIENT MONITORING SYSTEM
INVIVO CORPORATION                510(k) NO: K132359(SPECIAL)
ATTN: RUSTY  KELLY                PHONE NO : 407 455 6166   
12151 RESEARCH PKWY               SE DECISION MADE: 30-AUG-13
ORLANDO FL 32826                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRA LICOX PTO2 MONITOR
INTEGRA LIFESCIENCES CORP.        510(k) NO: K131184(TRADITIONAL)
ATTN: ELIZABETH  MCMENIMAN        PHONE NO : 781 565 1347   
22 TERRY AVENUE                   SE DECISION MADE: 30-AUG-13
BURLINGTON MA 01830               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HORIZON XVU (FFR)
MENNEN MEDICAL LTD.               510(k) NO: K123792(TRADITIONAL)
ATTN: IFAT  SHWARTS               PHONE NO : 972 8 9323313
4 HAYARDEN ST., YAVNE P.O.BOX 102 SE DECISION MADE: 30-AUG-13
REHOVOT    IS 76100               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL
KURARAY NORITAKE DENTAL INC.      510(k) NO: K131430(TRADITIONAL)
ATTN: MICHIO  TAKIGAWA            PHONE NO : 81 3 67011706
OTE CENTER BLDG 7F 1-1-3, OTEMACHISE DECISION MADE: 30-AUG-13
CHIYODA-KU    JA 100-0004         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIRIUS FEMORAL STEM
BIOMET, INC.                      510(k) NO: K130610(TRADITIONAL)
ATTN: BECKY  EARL                 PHONE NO : 574 267 6639   
56 EAST BELL DR.                  SE DECISION MADE: 30-AUG-13
WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
CILAG GMBH INTERNATIONAL          510(k) NO: K131363(TRADITIONAL)
ATTN: OYINKAN  DONALDSON          PHONE NO : 44 014637 21259
GUBELSTRASSE 34                   SE DECISION MADE: 30-AUG-13
ZUG    SZ 6300                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTIMA CT660
GE MEDICAL SYSTEMS, LLC           510(k) NO: K131576(TRADITIONAL)
ATTN: HELEN  PENG                 PHONE NO : 262 424 8222   
3000 N GRANDVIEW BLVD.            SE DECISION MADE: 30-AUG-13
WAUKESHA WI 53188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RESTORE MODULAR STERILIZATION TRAY SYSTEM
RESTORE MEDICAL SOLUTIONS, INC.   510(k) NO: K131455(TRADITIONAL)
ATTN: PATSY J TRISLER             PHONE NO : 301 652 5344   
5600 WISCONSIN AVE. #509          SE DECISION MADE: 30-AUG-13
CHEVY CHASE MD 20815              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVASC THROMBECTOMY DEVICE
CODMAN & SHURTLEFF, INC.          510(k) NO: K132281(SPECIAL)
ATTN: AMARILYS  MACHADO           PHONE NO : 305 265 6869   
325 PARAMOUNT DR.                 SE DECISION MADE: 30-AUG-13
RAYNHAM MA 02767 0350             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAYLIS MEDICAL RF PERFORATION PROBE V2.0
BAYLIS MEDICAL COMPANY INC.       510(k) NO: K132374(SPECIAL)
ATTN: MEGHAL  KHAKHAR             PHONE NO : 905 602 4875
2645 MATHESON BLVD. EAST          SE DECISION MADE: 30-AUG-13
MISSISSAUGA, ONTARIO    CA L4W 5S4510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6
SHENZHEN PANGO ELECTRONIC CO., LTD510(k) NO: K131558(TRADITIONAL)
ATTN: XIAOYUN  YANG               PHONE NO : 86 755 33825988
XIKENG VILLAGE, HENGGANG TOWN, LONSE DECISION MADE: 30-AUG-13
ZHENZHEN, GUANGDONG    CH 518115  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A)
ST. SHINE OPTICAL CO., LTD.       510(k) NO: K132146(TRADITIONAL)
ATTN: ELLA  LEE                   PHONE NO : 886 2 26479356
4,5 F/L NO. 276-2 SEC. 1 TATUNG RDSE DECISION MADE: 30-AUG-13
TAIPEI HSIEN    TW 221            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RANGE SPINAL SYSTEM
K2M, INC.                         510(k) NO: K131784(SPECIAL)
ATTN: NANCY  GIEZEN               PHONE NO : 703 777 3155   
751 MILLER DR.,SE                 SE DECISION MADE: 30-AUG-13
LEESBURG VA 20175                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM
C.R. BARD, INC.                   510(k) NO: K130792(TRADITIONAL)
ATTN: CHRISTOPH  WAGNER VON HOFF  PHONE NO : 480 638 2925   
1625 WEST 3RD ST.                 SE DECISION MADE: 30-AUG-13
TEMPE AZ 85281 1740               510(k) SUMMARY AVAILABLE FROM FDA


                                                 TOTAL 510(k)s THIS PERIOD   301                                     
                                                 TOTAL WITH SUMMARIES        281                                     
                                                 TOTAL WITH STATEMENTS        20
                                      

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