510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD August 2013
TOTAL 510(k)s THIS PERIOD 250
TOTAL WITH SUMMARIES 231
TOTAL WITH STATEMENTS 19
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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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
