510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD September 2013
TOTAL 510(k)s THIS PERIOD 214
TOTAL WITH SUMMARIES 195
TOTAL WITH STATEMENTS 19
DEVICE: PROSIGNA BREAST CANCER PROGNOSIS GENE SIGNATURE ASSAY
NANOSTRING TECHNOLOGIES 510(k) NO: K130010(TRADITIONAL)
ATTN: SYLVA KRIZAN, PHD PHONE NO : 206 378 6266
530 Fairview Ave N Ste 2000 SE DECISION MADE: 06-SEP-13
Seattle WA 98109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
VENTANA MEDICAL SYSTEMS, INC. 510(k) NO: K121033(TRADITIONAL)
ATTN: ERIKA AMMIRATI PHONE NO : 650 949 2768
575 SHIRLYNN COURT SE DECISION MADE: 06-SEP-13
LOS ALTOS CA 94022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON XL HCG
DIASORIN, INC. 510(k) NO: K131037(TRADITIONAL)
ATTN: MARI MEYER PHONE NO : 651 351 5635
1951 NORTHWESTERN AVE. P.O. BOX 28SE DECISION MADE: 06-SEP-13
STILLWATER MN 55082 0285 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUIDEL MOLECULAR RSV + HMPV ASSAY
QUIDEL CORP. 510(k) NO: K131813(TRADITIONAL)
ATTN: RONALD H LOLLAR PHONE NO : 858 552 1100
10165 MCKELLAR CT. SE DECISION MADE: 06-SEP-13
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XTAG CYP2C19 KIT V3
LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K131565(TRADITIONAL)
ATTN: RONALD DUNN PHONE NO : 608 203895 0
439 UNIVERSITY AVE. SE DECISION MADE: 11-SEP-13
TORONTO, ONTARIO CA M5G 1Y8 510(k) STATEMENT
DEVICE: VYSIS D7S486/CEP 7 FISH PROBE KIT
ABBOTT MOLECULAR, INC. 510(k) NO: K131508(TRADITIONAL)
ATTN: NANCY W BENGTSON PHONE NO : 224 361 7087
1300 EAST TOUHY AVENUE SE DECISION MADE: 13-SEP-13
DES PLAINES IL 60018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN
BIOMERIEUX, INC. 510(k) NO: K132573(TRADITIONAL)
ATTN: NATHAN HARDESTY PHONE NO : 314 731 8666
595 ANGLUM RD. SE DECISION MADE: 13-SEP-13
HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
VENTANA MEDICAL SYSTEMS, INC. 510(k) NO: K122143(TRADITIONAL)
ATTN: ERIKA B AMMIRATI PHONE NO : 650 949 2768
575 SHIRLYNN COURT SE DECISION MADE: 19-SEP-13
LOS ALTOS CA 94022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI
BIO-RAD LABORATORIES, INC. 510(k) NO: K130053(TRADITIONAL)
ATTN: JUANG WANG PHONE NO : 510 741 4609
5500 EAST 2ND ST. SE DECISION MADE: 19-SEP-13
BENICIA CA 94510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS HERCEPTEST DIGITAL SCORE
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K130021(TRADITIONAL)
ATTN: DIRK VOSSEN PHONE NO : 316 511 81374
VEENPLUIS 4-6 SE DECISION MADE: 19-SEP-13
BEST, NB NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
CENTERS FOR DISEASE CONTROL AND PR510(k) NO: K132508(TRADITIONAL)
ATTN: HYE-JOO KIM, PHARM.D. PHONE NO : 404 639 4643
1600 CLIFTON RD., N.E. MAILSTOP C-SE DECISION MADE: 23-SEP-13
ATLANTA GA 30333 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
VENTANA MEDICAL SYSTEMS, INC. 510(k) NO: K121516(TRADITIONAL)
ATTN: ERIKA AMMIRATI PHONE NO : 650 949 2768
575 SHIRLYNN COURT SE DECISION MADE: 26-SEP-13
LOS ALTOS CA 94022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST
TIANJIN NEW BAY BIORESEARCH CO., L510(k) NO: K130275(TRADITIONAL)
ATTN: ROGER DE BOCK PHONE NO : 619 453 0930
4455 MURPHY CANYON RD SUITE 204 SE DECISION MADE: 26-SEP-13
SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K132630(TRADITIONAL)
ATTN: JOE SHIA PHONE NO : 240 505 7880
504 EAST DIAMOND AVE. SUITE F SE DECISION MADE: 27-SEP-13
GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARILIFT-L INTERBODY FUSION DEVICE
WENZEL SPINE, INC. 510(k) NO: K131296(TRADITIONAL)
ATTN: SANDIE ROTH PHONE NO : 512 501 4022
206 WILD BASIN RD, BLDG A, STE 203SE DECISION MADE: 03-SEP-13
AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARDIS INTERBODY SYSTEM
ZIMMER SPINE, INC 510(k) NO: K131242(TRADITIONAL)
ATTN: JON GILBERT PHONE NO : 952 830 6385
SE DECISION MADE: 03-SEP-13
MINNEAPOLIS MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,
BIOMET MANUFACTURING CORP. 510(k) NO: K123907(TRADITIONAL)
ATTN: ELIZABETH WRAY PHONE NO : 574 371 1176
56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 03-SEP-13
WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESURFX 1565NM LASER MODULE
LUMENIS, LTD. 510(k) NO: K130028(TRADITIONAL)
ATTN: YORAM LEVY PHONE NO : 972 4638 8837
31 HAAVODA ST. SE DECISION MADE: 03-SEP-13
BINYAMINA IS 30500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U-MOTION II PS+ CUP
UNITED ORTHOPEDIC CORP. 510(k) NO: K132455(SPECIAL)
ATTN: FANG-YUAN HO PHONE NO : 886 357 73351X2217
NO 57, PARK AVE. 2, SCIENCE PARK SE DECISION MADE: 03-SEP-13
HSINCHU TW 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE
VERTEBRAL TECHNOLOGIES, INC. 510(k) NO: K131540(TRADITIONAL)
ATTN: SURESH GHAI PHONE NO : 952 979 9357
5909 BAKER ROAD SUITE 550 SE DECISION MADE: 03-SEP-13
MINNETONKA MN 55345 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
ACCEL SPINE 510(k) NO: K132366(SPECIAL)
ATTN: AEKTA PATEL PHONE NO : 214 545 5833
14901 QUORUM DR. STE. 125 SE DECISION MADE: 03-SEP-13
DALLAS TX 75254 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH
ACCESS SCIENTIFIC, LLC 510(k) NO: K131148(TRADITIONAL)
ATTN: ALBERT MISAJON PHONE NO : 858 259 8333
3910 Sorrento Valley Blvd Ste 200 SE DECISION MADE: 04-SEP-13
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
DIACOUSTIC MEDICAL DEVICES (PTY) L510(k) NO: K131044(TRADITIONAL)
ATTN: YOLANDA SMITH PHONE NO : 888 729 9674
1468 HARWELL AVENUE SE DECISION MADE: 04-SEP-13
CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSPACE
BIOSPACE CORPORATION LIMITED 510(k) NO: K131064(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 04-SEP-13
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA INTERSPINOUS PROCESS SYSTEM
SEASPINE, INC. 510(k) NO: K121924(TRADITIONAL)
ATTN: NICK M CORDARO PHONE NO : 760 216 5603
2302 la Mirada Dr SE DECISION MADE: 04-SEP-13
VISTA CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARIS SPINAL SYSTEM
BIOMET SPINE (AKA EBI, LLC) 510(k) NO: K131615(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 973 299 9300
399 JEFFERSON ROAD SE DECISION MADE: 04-SEP-13
PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS
GE HUNGARY KFT 510(k) NO: K132045(TRADITIONAL)
ATTN: STEPHEN SLAVENS PHONE NO : 262 548 4992
3000 N GRANDVIEW DIVISION: DBA GE SE DECISION MADE: 04-SEP-13
WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
ZIMMER SPINE, INC. 510(k) NO: K131980(TRADITIONAL)
ATTN: JONATHAN GILBERT PHONE NO : 952 830 6385
7375 BUSH LAKE RD. SE DECISION MADE: 04-SEP-13
MINNEAPOLIS MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5MP GRAYSCALE LCD DISPLAY
SHENZHEN BEACON DISPLAY TECHNOLOGY510(k) NO: K132610(TRADITIONAL)
ATTN: WU QIN PHONE NO : 86 755 26995355
RM 201, INCUBATOR BUILDING, CASTD,SE DECISION MADE: 04-SEP-13
SHENZHEN CH 518057 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KOSTEC MEDICAL GRADE LDC MONITORS
KOSTEC CO., LTD 510(k) NO: K123944(TRADITIONAL)
ATTN: RHONDA ALEXANDER, MS, MPA PHONE NO : 757 224 0177
144 RESEARCH DRIVE MEDICAL DEVICE SE DECISION MADE: 05-SEP-13
HAMPTON VA 23666 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STITCHKIT
ORIGAMI SURGICAL LLC 510(k) NO: K123811(TRADITIONAL)
ATTN: JOHN GILLESPIE PHONE NO : 774 567 0277
79 HAVEN ST. SE DECISION MADE: 05-SEP-13
DOVER MA 02030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
SYNTHES 510(k) NO: K123723(TRADITIONAL)
ATTN: ALAN T HALEY PHONE NO : 484 356 9763
1301 GOSHEN PARKWAY SE DECISION MADE: 05-SEP-13
WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIX FOOT SYSTEM
JEIL MEDICAL CORPORATION 510(k) NO: K131311(TRADITIONAL)
ATTN: JI-EUN KIM PHONE NO : 82 2 8503500
#702, KOLON SCIENCE VALLEY 2ND 811SE DECISION MADE: 05-SEP-13
SEOUL-CITY KS 152-050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUMED WRIST SPANNING PLATE
ACUMED LLC 510(k) NO: K131764(TRADITIONAL)
ATTN: NATHAN WOLF PHONE NO : 503 207 1502
5885 NW Cornelius Pass Rd SE DECISION MADE: 05-SEP-13
HILLSBORO OR 97124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300
ST. JUDE MEDICAL SYSTEMS AB 510(k) NO: K131452(TRADITIONAL)
ATTN: ERDULFO DE PERALTA PHONE NO : 978 577 3481
4 ROBBINS RD. SE DECISION MADE: 05-SEP-13
WESTFORD MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z5MLB, Z5MLC
Z-SYSTEMS AG 510(k) NO: K131701(TRADITIONAL)
ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235
12264 EL CAMINO REAL STE. 400 SE DECISION MADE: 05-SEP-13
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEPHAFLEX BRAIDED SUTURE
TEPHA, INC. 510(k) NO: K132348(TRADITIONAL)
ATTN: MARY P LEGRAW PHONE NO : 781 357 1709
99 HAYDEN, SUTIE 360 SE DECISION MADE: 05-SEP-13
LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON 25 TOTAL-D
DIASORIN, INC. 510(k) NO: K132492(TRADITIONAL)
ATTN: MARI MEYER PHONE NO : 651 351 5635
1951 NORTHWESTERN AVE. P.O. BOX 28SE DECISION MADE: 05-SEP-13
STILLWATER MN 55082 0285 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
TELEFLEX MEDICAL, INC. 510(k) NO: K122235(SPECIAL)
ATTN: LORI PFOHL PHONE NO : 919 433 4908
2917 WECK DR. SE DECISION MADE: 06-SEP-13
RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREEMIE BREAST COLLECTION SYSTEM
DAO HEALTH 510(k) NO: K130349(TRADITIONAL)
ATTN: DAN GARBEZ PHONE NO : 916 339 7388
1345 EASY LN. EL DORADO HILLS SE DECISION MADE: 06-SEP-13
CALIFORNIA CA 95762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUSHA-C31 MEDICAL DISPLAY
NANJING JUSHA DISPLAY TECHNOLOGY C510(k) NO: K131389(TRADITIONAL)
ATTN: MIKE GU PHONE NO : 86 20 62321333
7TH FLOOR, 982. CONGYUN RD. BAIYUNSE DECISION MADE: 06-SEP-13
GUANGZHOU, GUANGDONG CH 510420 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPERCT REL. 3
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K130893(ABBREVIATED)
ATTN: LISELOTTE KORNMANN PHONE NO : 31 611621 238
VEENPLUIS 4-6 SE DECISION MADE: 06-SEP-13
BEST NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEAK Z
ULTRADENT PRODUCTS, INC. 510(k) NO: K131357(TRADITIONAL)
ATTN: DIANE ROGERS PHONE NO : 801 553 4491
505 WEST 10200 SOUTH SE DECISION MADE: 06-SEP-13
SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
WORLDMED MANUFACTURING SDN. BHD. 510(k) NO: K121844(TRADITIONAL)
ATTN: CHANDRASEGARAN PHONE NO : 605 829 5555
LOT 18873, JALAN PERUSAHAAN 3, KAMSE DECISION MADE: 06-SEP-13
KAMUNTING MY 34600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALIVECOR HEART MONITOR
ALIVECOR, INC. 510(k) NO: K130409(TRADITIONAL)
ATTN: MICHAEL RIGHTER PHONE NO : 415 795 9812
30 MAIDEN LANE, 6TH FLOOR SE DECISION MADE: 06-SEP-13
SAN FRANCISCO CA 94108 510(k) STATEMENT
DEVICE: STRAWBERRY, STRAWBERRY & CREAM
LASER LIPO LIMITED 510(k) NO: K130341(TRADITIONAL)
ATTN: IAN COBLEY PHONE NO : 011 44 8449801820
HEATH HOUSE, CROCKHAM HILL SE DECISION MADE: 06-SEP-13
EDENBRIDGE, KENT UK TN8 6ST 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE SEAMGUARD REINFORCEMENT
W. L. GORE & ASSOCIATES, INC. 510(k) NO: K131658(TRADITIONAL)
ATTN: BARBARA L SMITH PHONE NO : 410 506 8189
301 AIRPORT RD. SE DECISION MADE: 06-SEP-13
ELKTON MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST
MEDOS INTERNATIONAL SARL 510(k) NO: K132324(SPECIAL)
ATTN: KIRSTEN LEHMULLER PHONE NO : 508 828 3291
325 PARAMOUNT DRIVE SE DECISION MADE: 06-SEP-13
RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-PACK II NEEDLE – 27G X 3/4" THIN WALL
TERUMO EUROPE N.V. 510(k) NO: K132233(SPECIAL)
ATTN: M.J. AERTS PHONE NO : 320 163812 11
INTERLEUVENLAAN 40 SE DECISION MADE: 06-SEP-13
LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPREHENSIVE REVERSE SHOULDER SCREWS
BIOMET MANUFACTURING CORP. 510(k) NO: K132239(TRADITIONAL)
ATTN: PATRICIA S BERES PHONE NO : 574 267 6639
56 BELL DRIVE SE DECISION MADE: 06-SEP-13
WARSAW IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIRECR DENTALIMAGING SYSTEM
3DISC AMERICAS 510(k) NO: K131442(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 06-SEP-13
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EYESEECAM VHIT
INTERACOUSTICS A/S 510(k) NO: K131681(TRADITIONAL)
ATTN: ERIK NIELSEN PHONE NO : 45 637 13555
DREJERVAENGET 8 SE DECISION MADE: 06-SEP-13
ASSENS DA DK-5610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMAGE CPT SYSTEM
SOLTA MEDICAL, INC. 510(k) NO: K132431(SPECIAL)
ATTN: RAYMOND LEE PHONE NO : 510 259 7159
25881 INDUSTRIAL BLVD. SE DECISION MADE: 06-SEP-13
HAYWARD CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINGLE USE GROUNDING PAD
LCCS PRODUCTS LIMITED 510(k) NO: K132136(TRADITIONAL)
ATTN: PHONE NO :
7TH FL, JINGGUI BUSINESS BLDG, NO.SE DECISION MADE: 06-SEP-13
GUANGZHOU, GUANGDONG CH 510420 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESENIUS LIBERTY CYCLER
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K123630(TRADITIONAL)
ATTN: DENISE OPPERMANN PHONE NO : 781 699 4479
920 WINTER ST SE DECISION MADE: 09-SEP-13
WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPIRE PINK SERIES – HERBST
RESPIRE MEDICAL 510(k) NO: K131138(TRADITIONAL)
ATTN: DANIELA LEVY PHONE NO : 213 787 3026
22817 VENTURA BLVD #161 SE DECISION MADE: 09-SEP-13
WOODLAND HILLS CA 91364 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION
BAUSCH & LOMB INCORPORATED 510(k) NO: K132216(SPECIAL)
ATTN: SAMANTHA DUFFY PHONE NO : 585 338 8187
1400 NORTH GOODMAN ST. SE DECISION MADE: 09-SEP-13
ROCHESTER NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSIGN FLU A + B, STATUS FLU A & B
PRINCETON BIOMEDITECH CORP. 510(k) NO: K132465(SPECIAL)
ATTN: KYUNG-AH KIM, PH.D. PHONE NO : 732 274 1000
4242 U.S. RT. 1 SE DECISION MADE: 09-SEP-13
MONMOUTH JUNCTION NJ 08852 1905 510(k) STATEMENT
DEVICE: POWER FREE VINYL EXAMINATION GLOVES
WANG TONG XINGHUA CO., LTD 510(k) NO: K122102(TRADITIONAL)
ATTN: GUO YANG PHONE NO : 865 238 3495629
WEST OF GUO JING ROAD ECONOMIC DEVSE DECISION MADE: 09-SEP-13
XINGHUA CH 225700 510(k) STATEMENT
DEVICE: EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE
ST. JUDE MEDICAL 510(k) NO: K132073(SPECIAL)
ATTN: KRIS MILLER PHONE NO : 651 756 2954
ONE ST. JUDE MEDICAL DRIVE SE DECISION MADE: 09-SEP-13
ST. PAUL MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX UNIVERSAL ADHESIVE
APEX DENTAL MATERIALS, INC. 510(k) NO: K131043(TRADITIONAL)
ATTN: CHRIS KULTON PHONE NO : 847 719 1133
330 TELSER ROAD SE DECISION MADE: 10-SEP-13
LAKE ZURICH IL 60047 510(k) STATEMENT
DEVICE: CCS-200 SPIROMETER
BENSON MEDICAL INSTRUMENTS CO. 510(k) NO: K123896(TRADITIONAL)
ATTN: DAVID MAYOU PHONE NO : 612 827 2222
310FOURTH AVE SOUTH SUITE 5000 SE DECISION MADE: 10-SEP-13
MINNEAPOLIS MN 55415 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
CHURCH & DWIGHT CO., INC. 510(k) NO: K123567(TRADITIONAL)
ATTN: LISA BURNS PHONE NO : 609 497 7482
469 NORTH HARRISON STREET SE DECISION MADE: 10-SEP-13
PRINCETON NJ 08543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIGER SPINE SYSTEM
CORELINK LLC 510(k) NO: K131250(TRADITIONAL)
ATTN: MEREDITH MAY PHONE NO : 719 337 7579
4628 NORTHPARK DRIVE SE DECISION MADE: 10-SEP-13
COLORADO SPRINGS CO 80918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETROGRADE FEMORAL NAIL
ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K132005(TRADITIONAL)
ATTN: ALLYSON PARKS PHONE NO : 310 533 9966
386 Beech Ave. Unit B6 SE DECISION MADE: 10-SEP-13
TORRANCE CA 90501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
BAUSCH & LOMB, INC. 510(k) NO: K131208(TRADITIONAL)
ATTN: BARBARA KLUBE-FALSO PHONE NO : 585 338 8503
1400 NORTH GOODMAN ST. SE DECISION MADE: 11-SEP-13
ROCHESTER NY 14609 3547 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IHEALTH FINGERTIP PULSE OXIMETER
ANDON HEALTH CO.,LTD 510(k) NO: K131111(TRADITIONAL)
ATTN: LIU YU PHONE NO : 86 22 60526161
#3, JIN PING STREET YA AN RD NANKSE DECISION MADE: 11-SEP-13
TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHOFU BLOCK HC
SHOFU DENTAL CORPORATION 510(k) NO: K130841(TRADITIONAL)
ATTN: DAVID P MORAIS PHONE NO : 760 736 3277
1225 STONE DRIVE SE DECISION MADE: 11-SEP-13
SAN MARCOS CA 92078 510(k) STATEMENT
DEVICE: PULSE OXIMETER
NONIN MEDICAL, INC. 510(k) NO: K131021(TRADITIONAL)
ATTN: BRODIE PEDERSEN PHONE NO : 763 577 3180
13700 1ST AVE. NORTH SE DECISION MADE: 11-SEP-13
PLYMOUTH MN 55441 5443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KITAZATO IUI CATHETER
KITAZATO MEDICAL CO., LTD. 510(k) NO: K131491(TRADITIONAL)
ATTN: RICHARD VINCINS, CBA, CQA, PHONE NO : 512 327 9997
816 CONGRESS AVE. STE. 1400 SE DECISION MADE: 11-SEP-13
AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL GOWN (EO STERILIZED)
COBES INDUSTRIES CO., LTD. 510(k) NO: K112796(TRADITIONAL)
ATTN: LEON LU PHONE NO : 877 202 1588
3500 SOUTH DUPONT HIGHWAY SE DECISION MADE: 12-SEP-13
DOVER DE 19901 510(k) STATEMENT
DEVICE: AUTOMATIC BLOOD PRESSURE MONITOR
HONSUN (NANTONG) CO., LTD. 510(k) NO: K130925(TRADITIONAL)
ATTN: SELINA QIAN PHONE NO : 86 0513 80580022
NO.8, Tongxing Road, Nantong EconoSE DECISION MADE: 12-SEP-13
NANTONG, JIANGSU CH 226009 510(k) STATEMENT
DEVICE: JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE
JUNG RIM MEDICAL INDUSTRIAL CO., L510(k) NO: K124037(TRADITIONAL)
ATTN: KYU LEE PHONE NO : 82 2 4047986
#593-81, SAGOK-RI, LWOL-MYEON SE DECISION MADE: 12-SEP-13
JINCHEON-GUN, CHUNGBUK KN 365-8510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S
AUDIFON-USA INC. 510(k) NO: K130417(ABBREVIATED)
ATTN: JANE E PERRONE PHONE NO : 386 668 8812
403 CHAIRMAN CT., STE. 1 SE DECISION MADE: 12-SEP-13
DEBARY FL 32713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPROPHY MOBILE
NAKANISHI, INC. 510(k) NO: K131578(TRADITIONAL)
ATTN: DIANE RUTHERFORD PHONE NO : 972 480 9554
1201 RICHARDSON DRIVE SUITE 280 SE DECISION MADE: 12-SEP-13
RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSAL PASTE STAINS AND GLAZE
PRISMATIK DENTALCRAFT, INC. 510(k) NO: K130604(TRADITIONAL)
ATTN: ARMIN ZEHTABCHI PHONE NO : 949 225 1234
2212 DUPONT DR., SUITE JJK SE DECISION MADE: 12-SEP-13
IRVINE CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVORTE BVF
VIVORTE, INC 510(k) NO: K130703(TRADITIONAL)
ATTN: STEPHEN J PEOPLES PHONE NO : 260 645 0327
5010 LODGE PLE LANE SE DECISION MADE: 12-SEP-13
FORT WAYNE IN 46814 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QXLINK
VIEWORKS CO., LTD. 510(k) NO: K132302(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 202 5789
1515 E. KATELLA AVENUE UNIT 2115 SE DECISION MADE: 12-SEP-13
ANAHEIM CA 92805 510(k) STATEMENT
DEVICE: EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM
DEPUY SPINE, A JOHNSON & JOHNSON C510(k) NO: K131802(SPECIAL)
ATTN: KIRSTEN LEHMULLER PHONE NO : 508 828 3291
325 PARAMOUNT DRIVE SE DECISION MADE: 12-SEP-13
RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTISTIM
METRON MEDICAL AUSTRALIA PTY LTD 510(k) NO: K132137(SPECIAL)
ATTN: DAVID MITCHELL PHONE NO : 613 977 51234
57 ASTER AVE. SE DECISION MADE: 12-SEP-13
CARRUM DOWNS, VICTORIA AS 3201 510(k) STATEMENT
DEVICE: ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
CEREMED, INC. 510(k) NO: K132198(TRADITIONAL)
ATTN: CHELSEA MITCHELL PHONE NO : 310 815 2125
3643 LENAWEE AVE. SE DECISION MADE: 12-SEP-13
LOS ANGELES CA 90016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCULIF TL AND PL CAGE
COALIGN INNOVATIONS, INC. 510(k) NO: K132505(SPECIAL)
ATTN: PHONE NO :
1331 H STREET NW 12TH FLOOR SE DECISION MADE: 12-SEP-13
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAS PSI KNEE SYSTEM
ORTHOSOFT, INC. 510(k) NO: K131409(TRADITIONAL)
ATTN: CHRISTOPHER MCLEAN PHONE NO : 514 861 4074
75 QUEEN ST., SUITE 3300 SE DECISION MADE: 13-SEP-13
MONTREAL, QUEBEC CA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
INTUITIVE SURGICAL, INC. 510(k) NO: K124031(TRADITIONAL)
ATTN: CINDY DOMECUS PHONE NO : 650 343 4813
1266 KIFER ROAD BUILDING 101 SE DECISION MADE: 13-SEP-13
SUNNYVALE CA 94086 5206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIONEER ELITE DIODE LASER
CAO GROUP, INC. 510(k) NO: K131059(TRADITIONAL)
ATTN: ROBERT K LARSEN PHONE NO : 801 256 9282
4628 WEST SKYHAWK DRIVE SE DECISION MADE: 13-SEP-13
WEST JORDAN UT 84084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K132175(TRADITIONAL)
ATTN: LUKE MEIDELL PHONE NO : 801 565 6212
12050 LONE PEAK PKWY SE DECISION MADE: 13-SEP-13
DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE
BINDER BIOMEDICAL, INC 510(k) NO: K130641(TRADITIONAL)
ATTN: LAWRENCE BINDER PHONE NO : 561 981 2682
1951 NW 7TH AVENUE, STE 13135 SE DECISION MADE: 13-SEP-13
MIAMI FL 33136 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
OKTX LLC 510(k) NO: K123902(TRADITIONAL)
ATTN: MARY ROSE C REASTON PHONE NO : 702 234 1014
7225 S 85TH E AVE. SUITE 300 SE DECISION MADE: 13-SEP-13
TULSA OK 74137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOBSTER AUTO-INJECTOR
SCANDINAVIAN HEALTH LIMITED 510(k) NO: K124026(TRADITIONAL)
ATTN: JAMES HAYNES PHONE NO : 954 725 2046
#588 JIM MORAN BLVD SE DECISION MADE: 13-SEP-13
DEERFIELD BEACH FL 33442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SASMAR ORIGINAL, SASMAR CLASSIC
SASMAR INC 510(k) NO: K131084(TRADITIONAL)
ATTN: JOHN-MICHAEL MANCINI PHONE NO : 773 942 0030
155 NORTH WACKER DR, STE 4250 SE DECISION MADE: 13-SEP-13
CHICAGO IL 60606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M
VITAL ACCESS 510(k) NO: K130873(TRADITIONAL)
ATTN: CHRISTOPHER PHILLIPS PHONE NO : 801 433 9390
2302 S.PRESIDENTS DR SUITE C SE DECISION MADE: 13-SEP-13
SALT LAKE CITY UT 84120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TANYX
MEDECELL US, INC 510(k) NO: K123866(TRADITIONAL)
ATTN: RHONDA ALEXANDER, M.S., M.PPHONE NO : 757 224 0177
144 RESEARCH DRIVE SE DECISION MADE: 13-SEP-13
HAMPTON VA 23666 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERLOCK – 18 FIBERED IDC OCCLUSION SYSTEM
BOSTON SCIENTIFIC CORP. 510(k) NO: K132578(SPECIAL)
ATTN: TODD KORNMANN PHONE NO : 763 494 1348
ONE SCIMED PLACE SE DECISION MADE: 13-SEP-13
MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEROX
OR-NIM MEDICAL LTD. 510(k) NO: K131854(SPECIAL)
ATTN: MICHA OESTEREICH PHONE NO : 972 892 82801
15 ATIR YEDA ST. SE DECISION MADE: 13-SEP-13
KFAR SABA IS 4464312 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA CENTAUR FT4, ADVIA CENTAUR T4
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K132249(TRADITIONAL)
ATTN: MATTEW GEE PHONE NO : 914 524 2099
511 BENEDICT AVE. SE DECISION MADE: 13-SEP-13
TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROSURGICAL GENERATOR
BEIJING JINHENGWEI TECHNOLOGY DEVE510(k) NO: K130760(TRADITIONAL)
ATTN: LIGANG MAO PHONE NO : 86 10 67916414
NO. 631 XINGONG VILLAGE EAST SIDE SE DECISION MADE: 16-SEP-13
BEIJING CH 100069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PNEUPAC PARAPAC PLUS
SMITHS MEDICAL INTERNATIONAL LTD. 510(k) NO: K123957(TRADITIONAL)
ATTN: LORI BERENDS PHONE NO :
BRAMINGHAM BUSINESS PARK ENTERPRISSE DECISION MADE: 16-SEP-13
LUTON, BEDFORDSHIRE UK LU3 4BU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY CORAIL AMT HIP PROSTHESIS
DEPUY FRANCE S.A.S. 510(k) NO: K123991(TRADITIONAL)
ATTN: ALMA RELJA, RAC PHONE NO : 574 372 7349
700 ORTHOPAEDIC DRIVE SE DECISION MADE: 16-SEP-13
WARSAW IN 46581 510(k) STATEMENT
DEVICE: NOVOKNEE TOTAL KNEE SYSTEM
NOVOSOURCE INC 510(k) NO: K131398(TRADITIONAL)
ATTN: JAMES PINKSTON PHONE NO : 435 774 1502
560 W. GOLF COURSE RD CO-INNOVATIOSE DECISION MADE: 16-SEP-13
PROVIDENCE UT 84332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
SHENZHEN DONGDIXIN TECHNOLOGY CO, 510(k) NO: K130802(TRADITIONAL)
ATTN: JIANPING KANG PHONE NO : 86 755276 52471
XILIXIAOBAIMANG SE DECISION MADE: 16-SEP-13
SHENZHEN, GUANGDONG CH 518108 510(k) STATEMENT
DEVICE: RAMPART-O, RAMPART-T
SPINEOLOGY, INC. 510(k) NO: K132053(TRADITIONAL)
ATTN: BRYAN BECKER PHONE NO : 651 256 8534
7800 3RD ST N., SUITE 600 SE DECISION MADE: 16-SEP-13
ST. PAUL MN 55128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEART SYNC
HEART SYNC INC. 510(k) NO: K131494(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 16-SEP-13
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
HELIX MEDICAL, LLC 510(k) NO: K131745(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
1110 MARK AVE. SE DECISION MADE: 17-SEP-13
CARPINTERIA CA 93013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CREODENT SOLIDEX CUSTOM ABUTMENT
CREODENT PROSTHETICS LTD. 510(k) NO: K113738(TRADITIONAL)
ATTN: CALVIN SHIM PHONE NO : 212 302 3860
29TH WEST STREET 11TH FLOOR SE DECISION MADE: 17-SEP-13
NEW YORK NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FACIAL SPA
NUSKIN 510(k) NO: K122711(TRADITIONAL)
ATTN: PAUL RUBIN PHONE NO : 202 508 4709
ONE METRO CENTER 700 12TH STREET, SE DECISION MADE: 17-SEP-13
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR
RAYENCE CO., LTD 510(k) NO: K131114(TRADITIONAL)
ATTN: DAVE KIM PHONE NO : 713 467 2607
12946 KIMBERLEY LN SE DECISION MADE: 17-SEP-13
HOUSTON TX 77079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,
CIVCO MEDICAL INSTRUMENTS CO., INC510(k) NO: K131161(TRADITIONAL)
ATTN: AMANDA STAHLE PHONE NO : 319 248 6628
102 FIRST ST. SOUTH SE DECISION MADE: 17-SEP-13
Kalona IA 52247 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM
JINXINBAO ELECTRONIC CO.,LTD 510(k) NO: K130232(ABBREVIATED)
ATTN: HELEN NAN PHONE NO : 086 577886 06182
ROOM 404, BLDG 7, JINHUICHANG HOMESE DECISION MADE: 17-SEP-13
WENZHOU, ZHEJIANG CH 325000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANSWATCH WRIST MONITOR MODEL TS-0411
TAIWAN SCIENTIFIC CORPORATION 510(k) NO: K123130(TRADITIONAL)
ATTN: DEHCHUAN SUN PHONE NO : 886 2 86673362
10F, 88-4, MING-CHIUAN RD, SHIN-DISE DECISION MADE: 17-SEP-13
NEW TAIPEI TW 23141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL
ZIMMER, INC. 510(k) NO: K130595(TRADITIONAL)
ATTN: STEPHEN H MCKELVEY PHONE NO : 574 372 4944
P.O. BOX 708 SE DECISION MADE: 17-SEP-13
WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VCARE A
IVT MEDICAL LTD 510(k) NO: K121817(TRADITIONAL)
ATTN: ELI ORBACH PHONE NO : 972 299 32768
POB 6718 SE DECISION MADE: 17-SEP-13
EFRAT IS 91435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXLOCK EXTREME SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K132591(SPECIAL)
ATTN: DEREK LEWIS PHONE NO : 330 869 9562
1065 MEDINA ROAD SUITE 500 SE DECISION MADE: 17-SEP-13
MEDINA OH 44256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYSTALSERT DELIVERY SYSTEM
BAUSCH & LOMB 510(k) NO: K132593(SPECIAL)
ATTN: YI GAO PHONE NO : 949 521 7933
30 ENTERPRISE, SUITE 450 SE DECISION MADE: 17-SEP-13
ALISO VIEJO CA 92656 7115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
EDAN INSTRUMENTS, INC. 510(k) NO: K131830(TRADITIONAL)
ATTN: CHERRY SUN PHONE NO : 867 55 26856469
EQUIPMENTS PARK, NANHAI RD 1019 NOSE DECISION MADE: 17-SEP-13
SHENZHEN CH 518067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT
GE HEALTHCARE 510(k) NO: K131977(TRADITIONAL)
ATTN: NICOLE LANDREVILLE PHONE NO : 289 208 2365
540 W. NORTHWEST HIGHWAY SE DECISION MADE: 17-SEP-13
BARRINGTON IL 60010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA
ARTHROCARE CORPORATION 510(k) NO: K132590(SPECIAL)
ATTN: MITCHELL DHORITY PHONE NO : 512 358 5995
7000 West William Cannon Drive SE DECISION MADE: 17-SEP-13
Austin TX 78735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABL90 FLEX ANALYZER
RADIOMETER MEDICAL APS 510(k) NO: K131988(TRADITIONAL)
ATTN: GITTE JUEL FRIIS PHONE NO : 453 82 73384
AKANDEVEJ 21 SE DECISION MADE: 17-SEP-13
BRONSHOJ DA DK-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTSPAN STEERABLE INTRODUCER KIT
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K132164(SPECIAL)
ATTN: ALINA STUBBS PHONE NO : 610 651 5000
65 GREAT VALLEY PAKRWAY SE DECISION MADE: 17-SEP-13
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC-3000E DIGITAL COLPOSCOPE
GOLDCARE MEDITECH CO., LTD 510(k) NO: K122311(TRADITIONAL)
ATTN: JIMMY WU PHONE NO : 626 799 0989
2600 MISSION STREET STE 100 SE DECISION MADE: 18-SEP-13
SAN MARINO CA 91108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALPHA-PRO WHITE VARNISH
DENTAL TECHNOLOGIES, INC. 510(k) NO: K124025(TRADITIONAL)
ATTN: PAULA ERICKSON PHONE NO : 847 677 5500
6901 NORTH HAMLIN AVE. SE DECISION MADE: 18-SEP-13
Lincolnwood IL 60712 510(k) STATEMENT
DEVICE: TRANSTEK GLASS BODY FAT ANALYZER
GUANGDONG TRANSTEK MEDICAL ELECTRO510(k) NO: K131394(SPECIAL)
ATTN: LEO WANG PHONE NO : 086 28 86083300
NO.1 FANGHUA STREET, HI-TECH DISTRSE DECISION MADE: 18-SEP-13
CHENGDU, SICHUAN CH 610041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTBUILDER SYSTEM (SB1)
OSSTEM IMPLANT CO.,LTD 510(k) NO: K130840(TRADITIONAL)
ATTN: PATRICK LIM PHONE NO : 888 678 0001
85 BEN FAIRLESS DR. SE DECISION MADE: 18-SEP-13
FAIRLESS HILLS PA 19030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
RENOVIS SURGICAL TECHNOLOGIES, LLC510(k) NO: K131122(ABBREVIATED)
ATTN: SHARYN ORTON, PH.D. PHONE NO : 401 330 8264
200 HOMER AVE SE DECISION MADE: 18-SEP-13
ASHLAND MA 01721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIOS FLOW CYTOMETER SYSTEM
BECKMAN COULTER, INC. 510(k) NO: K130373(TRADITIONAL)
ATTN: NANCY NADLER PHONE NO : 305 380 4191
11800 SW 147 AVE SE DECISION MADE: 18-SEP-13
MIAMI FL 33196 2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLINE ANTI-REFLUX VALVE
MEDLINE INDUSTRIES, INC. 510(k) NO: K132314(TRADITIONAL)
ATTN: MATT CLAUSEN PHONE NO : 847 643 4785
ONE MEDLINE PLACE SE DECISION MADE: 18-SEP-13
MUNDELEIN IL 60060 510(k) STATEMENT
DEVICE: APD LUER-LOCK ADAPTER
FRESENSIUS MEDICAL CARE NORTH AMER510(k) NO: K124024(TRADITIONAL)
ATTN: DENISE OPPERMANN PHONE NO : 781 699 4479
920 WINTER ST SE DECISION MADE: 19-SEP-13
WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOLAP SYSTEM
MST – MEDICAL SURGERY TECHNOLOGIES510(k) NO: K131375(TRADITIONAL)
ATTN: JOHN J SMITH, M.D., J.D. PHONE NO : 202 637 3638
555 THIRTEENTH STREET NW SE DECISION MADE: 19-SEP-13
WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
ZIMMER, INC. 510(k) NO: K130810(TRADITIONAL)
ATTN: SCOTT M DURLACHER PHONE NO : 317 569 9500
9001 WESLEYAN ROAD, STE 200 SE DECISION MADE: 19-SEP-13
INDIANAPOLIS IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENOVIS BIPOLAR HIP SYSTEM
RENOVIS SURGICAL TECHNOLOGIES LLC 510(k) NO: K131354(TRADITIONAL)
ATTN: SHARYN ORTON PHONE NO : 401 330 8264
200 HOMER AVE SE DECISION MADE: 19-SEP-13
ASHLAND MA 0172 0000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00
INTERVENTIONAL SPINE, INC. 510(k) NO: K132479(SPECIAL)
ATTN: JANE METCALF PHONE NO : 949 472 0006
13700 ALTON PKWY., SUITE 160 SE DECISION MADE: 19-SEP-13
IRVINE CA 92618 510(k) STATEMENT
DEVICE: PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
PIPELINE BIOTECHNOLOGY 510(k) NO: K132626(SPECIAL)
ATTN: TERRY POWELL PHONE NO : 703 562 9800
575 EIGHTH AVE, SUITE 1212 SE DECISION MADE: 19-SEP-13
NEW YORK NY 10018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EQUINOX CO2 LASER
ECLIPSE AESTHETICS, LLC 510(k) NO: K131903(SPECIAL)
ATTN: TOM O’BRIEN PHONE NO : 972 380 2911
13988 Diplomat Dr Suite 160 SE DECISION MADE: 19-SEP-13
Dallas TX 75234 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES
TORNIER, INC. 510(k) NO: K132632(SPECIAL)
ATTN: JANELL A COLLEY PHONE NO : 952 426 7600
10801 NESBITT AVENUE SOUTH SE DECISION MADE: 19-SEP-13
BLOOMINGTON MN 55437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER
ARTHROCARE CORPORATION 510(k) NO: K132513(SPECIAL)
ATTN: MITCHELL DHORITY PHONE NO : 512 358 5995
7000 WEST WILLIAM CANNON DRIVE SE DECISION MADE: 19-SEP-13
AUSTIN TX 78735 0000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU
CORENTEC CO., LTD 510(k) NO: K132644(SPECIAL)
ATTN: J.S. DANIEL PHONE NO : 827 04 3933819
8TH FLOOR CHUNGHO TOWER 748-1 BANPSE DECISION MADE: 19-SEP-13
SEOCHO GU, SEOUL KN 137-040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WINGMAN EXTENDABLE TIP SUPPORT CATHETER
REFLOW MEDICAL 510(k) NO: K132420(SPECIAL)
ATTN: REBECCA K PINE PHONE NO : 760 809 5178
1003 Calle Sombra SE DECISION MADE: 19-SEP-13
San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINUFLUSH LAVAGE SYSTEM
HEDGEPATH, LLC 510(k) NO: K131177(TRADITIONAL)
ATTN: FRANK E O’DONNELL, JR MD. PHONE NO : 314 258 6446
324 S. HYDE PARK AVE. SUITE 350 SE DECISION MADE: 20-SEP-13
TAMPA FL 33606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MROZ REVERSE OSMOSIS SYSTEM
AMERIWATER 510(k) NO: K131622(TRADITIONAL)
ATTN: BRIAN R BOWMAN PHONE NO : 937 461 8833
1303 STANLEY AVE. SE DECISION MADE: 20-SEP-13
DAYTON OH 45404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL
SIEMENS HELATHCARE DIAGNOSTICS INC510(k) NO: K132391(ABBREVIATED)
ATTN: GARO MIMARYAN PHONE NO : 914 524 3270
511 BENEDICT AVENUE SE DECISION MADE: 20-SEP-13
TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROPLEX COIL SYSTEM (MCS), VFC
MICROVENTION, INC. 510(k) NO: K132317(SPECIAL)
ATTN: LARAINE PANGELINA PHONE NO : 714 247 8150
1311 VALENCIA AVE SE DECISION MADE: 20-SEP-13
TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTICHEM IA AND IA PLUS
TECHNO-PATH MANUFACTURING LTD. 510(k) NO: K132091(ABBREVIATED)
ATTN: STEPHANIE G GARTH PHONE NO : 469 230 0959
325 BIG ELM ST. SE DECISION MADE: 20-SEP-13
HIGHLAND VILLAGE TX 75077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COROENT SINGLE TAB SYSTEM
NUVASIVE, INC. 510(k) NO: K131723(TRADITIONAL)
ATTN: JEREMY MARKOVICH PHONE NO : 858 309 3783
7475 LUSK BLVD SE DECISION MADE: 20-SEP-13
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA
LEXION MEDICAL, LLC. 510(k) NO: K132203(TRADITIONAL)
ATTN: BERNARD HORWATH PHONE NO : 651 231 1761
4486 TIMBERLINE CT SE DECISION MADE: 20-SEP-13
VADNAIS HEIGHTS MN 55127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTICHEM WBT
TECHNO-PATH MANUFACTURING LTD. 510(k) NO: K132174(ABBREVIATED)
ATTN: STEPHANIE G GARTH PHONE NO : 469 230 0959
325 BIG ELM ST. SE DECISION MADE: 20-SEP-13
HIGHLAND VILLAGE TX 75077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIANCE CERVICAL IBF SYSTEM
RELIANCE MEDICAL SYSTEMS, LLC 510(k) NO: K131429(TRADITIONAL)
ATTN: BRET M BERRY PHONE NO : 801 295 3280
P.O. BOX 1693 SE DECISION MADE: 23-SEP-13
BOUNTIFUL UT 84011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER
ENCORE MEDICAL, L.P. 510(k) NO: K130365(TRADITIONAL)
ATTN: TEFFANY HUTTO PHONE NO : 512 832 9500
9800 METRIC BLVD. SE DECISION MADE: 23-SEP-13
AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELIMED STEAM STERILIZER MST-V
BELIMED, INC. 510(k) NO: K130172(ABBREVIATED)
ATTN: JAY UPCHURCH PHONE NO : 843 216 7424
2284 Clements Ferry Road SE DECISION MADE: 23-SEP-13
Charleston SC 29492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANATOMIC PEEK CERVICAL FUSION SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K130177(TRADITIONAL)
ATTN: LEE GRANT PHONE NO : 901 396 3133
1800 PYRAMID PLACE SE DECISION MADE: 23-SEP-13
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
DORNIER MEDTECH AMERICA 510(k) NO: K132672(SPECIAL)
ATTN: JOHN HOFFER PHONE NO : 770 514 6163
1155 ROBERTS BLVD. SE DECISION MADE: 23-SEP-13
KENNESAW GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K131888(TRADITIONAL)
ATTN: BECKY RONNER PHONE NO : 800 876 3133
1800 PYRAMID PLACE SE DECISION MADE: 23-SEP-13
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SFI-BAR
CENDRES & METAUX SA 510(k) NO: K131526(TRADITIONAL)
ATTN: TANJA BONGNI PHONE NO : 415 836023 02
RUE DE BOUJEAN 122 SE DECISION MADE: 23-SEP-13
BIEL/BIENNE SZ 2501 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: K132692(SPECIAL)
ATTN: GREGORY P PAYNE, RAC PHONE NO : 858 795 7890
10865 ROAD TO THE CURE SUITE 200 SE DECISION MADE: 23-SEP-13
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DESARA MESH, DESARA BLUE
CALDERA MEDICAL, INC. 510(k) NO: K132069(TRADITIONAL)
ATTN: VICKI GAIL PHONE NO : 818 483 7602
5171 CLARETON DRIVE SE DECISION MADE: 23-SEP-13
AGOURA HILLS CA 91301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAGNOCAM
KALTENBACH & VOIGT GMBH 510(k) NO: K123402(TRADITIONAL)
ATTN: STEFAN TRAMPLER PHONE NO : 49 735 10563515
BISMARCHRING 39 SE DECISION MADE: 24-SEP-13
BIBERACH / RISS GM 88400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE ECHOPAC
GE VINGMED ULTRASOUND AS 510(k) NO: K131685(TRADITIONAL)
ATTN: BRYAN BEHN PHONE NO : 47 330212 80
STRANDPROMENADEN 45 PO BOX 141 SE DECISION MADE: 24-SEP-13
HORTEN NO N-3191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOLUSON I/E
GE HEALTHCARE 510(k) NO: K131937(TRADITIONAL)
ATTN: BRYAN BEHN PHONE NO : 414 721 4214
9900 INNOVATION DRIVE SE DECISION MADE: 24-SEP-13
WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIXPLORER
SUPERSONIC IMAGINE 510(k) NO: K132274(SPECIAL)
ATTN: JACQUES SONQUET PHONE NO : 334 42 992424
510 RUE RENE DESCARTES SE DECISION MADE: 24-SEP-13
AIX-EN-PROVENCE CEDEX FR 13857510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIXPLORER
SUPERSONIC IMAGINE 510(k) NO: K132171(TRADITIONAL)
ATTN: AURELIE GRUENER PHONE NO : 33 442 992424
510 RUE RENE DESCARTES SE DECISION MADE: 24-SEP-13
AIX-EN-PROVENCE FR 13857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRILLIANCE ICT
PHILIPS HEALTHCARE (CLEVELAND) 510(k) NO: K131773(SPECIAL)
ATTN: CATHERINE M CONNELL PHONE NO : 440 483 5581
595 MINER RD. SE DECISION MADE: 24-SEP-13
CLEVELAND OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHENGGUANG MANUAL WHEELCHAIR
PINGDINGSHAN SHENXING HEALTHCARE T510(k) NO: K131529(TRADITIONAL)
ATTN: WANG QING PHONE NO :
XINXING RD. SOUTH OF INDUSTRIAL PASE DECISION MADE: 24-SEP-13
PINGDINGSHAN CITY, HENAN CH 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES
DENTALEZ GROUP, STARDENTAL DIVISIO510(k) NO: K130455(TRADITIONAL)
ATTN: JIM WATKINS PHONE NO : 717 291 1161
1816 COLONIAL VILLAGE LN. SE DECISION MADE: 25-SEP-13
LANCASTER PA 17601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-GEN
MEGAGEN IMPLANT CO., LTD 510(k) NO: K131289(TRADITIONAL)
ATTN: APRIL LEE PHONE NO : 714 525 0114
325 N PUENTE ST. UNIT B SE DECISION MADE: 25-SEP-13
BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX COMPRESSION PLATES
ARTHREX, INC. 510(k) NO: K130510(TRADITIONAL)
ATTN: IVETTE GALMEZ PHONE NO : 239 643 5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 25-SEP-13
NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)
METHODSENSE, INC. 510(k) NO: K131873(TRADITIONAL)
ATTN: RITA KING PHONE NO : 919 313 3960
P.O. BOX 110352 SE DECISION MADE: 25-SEP-13
DURHAM NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XVI R5.0
ELEKTA LIMITED 510(k) NO: K131965(TRADITIONAL)
ATTN: ANDREW HEDGES PHONE NO : 441 293654 201
LINAC HOUSE, FLEMING WAY SE DECISION MADE: 25-SEP-13
CRAWLEY, WEST SUSSEX UK RH10 9R510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECLIPSE TREATMENT PLANNING SYSTEM
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K131891(TRADITIONAL)
ATTN: PETER J CORONADO PHONE NO : 650 424 6320
911 HANSEN WAY SE DECISION MADE: 25-SEP-13
PALO ALTO CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES
LUCENXIA PRESCIENCE AG 510(k) NO: K131751(TRADITIONAL)
ATTN: ROBERT HILL PHONE NO : 41 417689 126
RATHAUSSTRASSE 7 SE DECISION MADE: 25-SEP-13
BAAR, ZUG SZ 6341 510(k) STATEMENT
DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
HEBEI HONGSEN PLASTICS TECHNOLOGY 510(k) NO: K131440(TRADITIONAL)
ATTN: CHARLES SHEN PHONE NO : 608 217 9358
5 CAREY STREET SE DECISION MADE: 25-SEP-13
PENNINGTON NJ 08534 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
BECKMAN COULTER, INC. 510(k) NO: K121790(TRADITIONAL)
ATTN: KERRIE OETTER PHONE NO : 952 368 7858
1000 LAKE HAZELTINE DR. SE DECISION MADE: 25-SEP-13
CHASKA MN 55318 1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JAZZ SYSTEM
HOGAN LOVELLS US LLP 510(k) NO: K132287(TRADITIONAL)
ATTN: JANICE M HOGAN PHONE NO : 267 675 4611
1835 MARKET ST 29TH FL SE DECISION MADE: 25-SEP-13
PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTICHEM P
TECHNO-PATH MANUFACTURING LTD. 510(k) NO: K131992(ABBREVIATED)
ATTN: STEPHANIE G GARTH PHONE NO : 469 230 0959
325 BIG ELM ST. SE DECISION MADE: 25-SEP-13
HIGHLAND VILLAGE TX 75077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
BAYER HEALTHCARE 510(k) NO: K122370(TRADITIONAL)
ATTN: ROGER SONNENBURG PHONE NO : 574 256 3441
430 SOUTH BEIGER STREET SE DECISION MADE: 26-SEP-13
MISHAWAKA IN 46544 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM
LIGHTMED CORP. 510(k) NO: K124043(TRADITIONAL)
ATTN: JOCELYN LIU PHONE NO : 886 22688 1726
NO.1-1, LANE1,PAO-AN ST. SEC.3 SHUSE DECISION MADE: 26-SEP-13
NEW TAIPEI CITY TW 23861 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COSEAL
JILIN CORONADO MEDICAL LTD. 510(k) NO: K131411(TRADITIONAL)
ATTN: ERIC CHIEN PHONE NO : 86 432635 29555
9 South-Western Circle Road FenmanSE DECISION MADE: 26-SEP-13
Jilin CH 132016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRO CT SYSTEM
MOBIUS IMAGING, LLC 510(k) NO: K131431(TRADITIONAL)
ATTN: NORMA LEMAY PHONE NO : 978 391 9644
323 WEST MAIN STREET SE DECISION MADE: 26-SEP-13
AYER MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION ONE LIFECARE; DETECTO; DETECTO
PRECISION ONE LIFECARE, LTD. 510(k) NO: K130952(TRADITIONAL)
ATTN: STEVEN CHERNOFF PHONE NO : 425 861 8262
PO BOX 3515 SE DECISION MADE: 26-SEP-13
REDMOND WA 98073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENII ARC SMART ARGON PROBE
GENII, INC. 510(k) NO: K130983(TRADITIONAL)
ATTN: TRACY EBERLY PHONE NO : 612 716 1209
3640 PILLSBURY AVE SE DECISION MADE: 26-SEP-13
MINNEAPOLIS MN 55409 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSCEND HEATED HUMIDIFIER
SOMNETICS INTERNATIONAL, INC. 510(k) NO: K131388(TRADITIONAL)
ATTN: MELINDA SWANSON PHONE NO : 651 621 1800
33 5TH AVE NW, STE 500 SE DECISION MADE: 26-SEP-13
NEW BRIGHTON MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIMETER INTERBODY FUSION DEVICE
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K132700(SPECIAL)
ATTN: ANKIT K SHAH PHONE NO : 800 876 3133
1800 PYRAMID PLACE SE DECISION MADE: 26-SEP-13
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132654(TRADITIONAL)
ATTN: PATRICK LYNCH PHONE NO : 650 694 5658
685 EAST MIDDLEFIELD ROAD SE DECISION MADE: 26-SEP-13
MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TCM MASSAGER
ANHUI JINJIANQIAO MED-TECH CO,. LT510(k) NO: K130150(TRADITIONAL)
ATTN: FIELD FU PHONE NO : 86 755 86069197
05C.FUHAI KANGLE BUILDING NANSHAN SE DECISION MADE: 26-SEP-13
SHENZHEN, GUANGDONG CH 518000 510(k) STATEMENT
DEVICE: PRIMI SUPPORT CATHETER
THERMOPEUTIX INC. 510(k) NO: K132701(SPECIAL)
ATTN: JASON FORD PHONE NO : 858 549 1760
9951B BUSINESSPARK AVE SE DECISION MADE: 26-SEP-13
SAN DIEGO CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)
GE MEDICAL SYSTEMS SCS 510(k) NO: K131885(TRADITIONAL)
ATTN: MOUNIR ZAOUALI PHONE NO : 33 130 704539
283 RUE DE LA MINIERE SE DECISION MADE: 26-SEP-13
BUC FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NANOCROSS ELITE .14" OVER-THE-WIRE PTA, BALLOON DILATION CATHETER
EV3 INC 510(k) NO: K132777(TRADITIONAL)
ATTN: PHONE NO :
3033 CAMPUS DRIVE SE DECISION MADE: 26-SEP-13
PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PROTURA COUCH SOFTWARE
MED-TEC, INC. D/B/A CIVCO MEDICAL 510(k) NO: K132084(TRADITIONAL)
ATTN: AMANDA STAHLE PHONE NO : 319 248 6628
1401 8TH STREET SE SE DECISION MADE: 26-SEP-13
ORANGE CITY IA 51041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COCHLEAR BAHA 4 SOUND PROCESSOR
COCHLEAR AMERICAS 510(k) NO: K132278(SPECIAL)
ATTN: SEAN BUNDY PHONE NO : 303 790 9010
13059 EAST PEAKVIEW AVENUE SE DECISION MADE: 26-SEP-13
CENTENNIAL CO 80111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESTEYA
NUCLETRON B.V. 510(k) NO: K132092(TRADITIONAL)
ATTN: LU ANNE JOHNSON PHONE NO : 715 403 5321
1917 29 3/4 AVE. SE DECISION MADE: 26-SEP-13
RICE LAKE WI 54868 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS DXL 12/16-LEAD ECG ALGORITHM
PHILIPS MEDICAL SYSTEMS 510(k) NO: K132068(SPECIAL)
ATTN: THERESA POOLE PHONE NO : 978 659 7621
3000 Minuteman Rd SE DECISION MADE: 26-SEP-13
ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS
ORFIT INDUSTRIES NV 510(k) NO: K131795(TRADITIONAL)
ATTN: EDDY MARIVOET PHONE NO : 320 33 262026
VOSVELD 9A SE DECISION MADE: 26-SEP-13
WIJNEGEM BE 2110 510(k) STATEMENT
DEVICE: CG+ ARROW JACC POWERED BY ARROW VPS STYLET
ARROW INTERNATIONAL(SUBSIDIARY OF 510(k) NO: K132133(SPECIAL)
ATTN: JULIE LAWSON PHONE NO : 610 378 0131
2400 BERNVILLE RD. SE DECISION MADE: 26-SEP-13
READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRINITY ACETABULAR SYSTEM
CORIN USA 510(k) NO: K131647(TRADITIONAL)
ATTN: DIANA L MARTONE PHONE NO : 813 977 4469
5670 W. CYPRESS ST. SUITE C SE DECISION MADE: 27-SEP-13
TAMPA FL 33607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THEYFIT MALE CONDOM
THEYFIT 510(k) NO: K122219(TRADITIONAL)
ATTN: PENNY NORTHCUTT PHONE NO : 678 428 6978
717 LAKEGLEN DRIVE SE DECISION MADE: 27-SEP-13
SUWANEE GA 30024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY-GRAFT
DEGRADABLE SOLUTIONS AG 510(k) NO: K131385(TRADITIONAL)
ATTN: DEBORAH LAVOIE GRAYESKI PHONE NO : 703 562 9800
901 KING STREET SUITE 101 SE DECISION MADE: 27-SEP-13
ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOK CERVICAL RIPENING BALLOON
COOK, INC. 510(k) NO: K131206(TRADITIONAL)
ATTN: CHIRS KILANDER PHONE NO : 812 339 2235
750 DANIELS WAY SE DECISION MADE: 27-SEP-13
Blmgtn IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES
MATERIALISE N.V. 510(k) NO: K131559(TRADITIONAL)
ATTN: ALEXANDRA RAZZHIVINA PHONE NO : 32 1639 6280
TECHNOLOGIELAAN 15 SE DECISION MADE: 27-SEP-13
LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BESTFIT2 NASAL MASK
CURATIVE MEDICAL INC. 510(k) NO: K130663(TRADITIONAL)
ATTN: AMY MCKINNEY PHONE NO : 979 236 1622
6518 TAMARIND SKY LN. SE DECISION MADE: 27-SEP-13
FULSHEAR TX 77441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER NAV3I PLATFORM
STRYKER CORPORATE 510(k) NO: K130874(TRADITIONAL)
ATTN: LILIAN ECKERT PHONE NO : 49 761 4512117
BOETZINGER STR. 41 SE DECISION MADE: 27-SEP-13
FREIBURG, BADEN-WUERTTEMBERG GM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASTERTORQUE LUX 8900 L
KALTENBACH & VOIGT GMBH 510(k) NO: K130560(TRADITIONAL)
ATTN: STEFAN TRAMPLER PHONE NO : 49 7351 563515
BISMARCKRING 39 SE DECISION MADE: 27-SEP-13
BIBERACH / RISS GM 88400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET
HK SURGICAL, INC. 510(k) NO: K123822(TRADITIONAL)
ATTN: CLARE BENNETT PHONE NO : 949 369 0101
1271 PUERTA DEL SOL SE DECISION MADE: 27-SEP-13
SAN CLEMENTE CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTRICARE 100CC/ 250CC/ 400CC CANISTERS
DEVON MEDICAL 510(k) NO: K132252(SPECIAL)
ATTN: RUTH WU PHONE NO : 610 757 4103
1100 FIRST AVENUE SUITE 202 SE DECISION MADE: 27-SEP-13
KING OF PRUSSIA PA 19406 510(k) STATEMENT
DEVICE: MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING
MEDTRONIC INC. 510(k) NO: K132030(TRADITIONAL)
ATTN: CHECHAMMA VARUGHESE PHONE NO : 763 523 2364
8200 CORAL SEA STREET MS MVS11 SE DECISION MADE: 27-SEP-13
MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LARGE (6") ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6") ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K131618(TRADITIONAL)
ATTN: JOHN CHESNEY PHONE NO : 734 741 6410
6200 JACKSON RD. SE DECISION MADE: 27-SEP-13
ANN ARBOR MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM
VOLCANO CORPORATION 510(k) NO: K132659(SPECIAL)
ATTN: MARCUS GARCIA PHONE NO : 978 439 3312
1 FORTUNE DRIVE SE DECISION MADE: 27-SEP-13
BILLERICA MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
HANSEN MEDICAL, INC. 510(k) NO: K132369(SPECIAL)
ATTN: HASSAN LABAY PHONE NO : 650 404 5888
800 EAST MIDDLEFIELD ROAD SE DECISION MADE: 27-SEP-13
MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MORCELLEX SIGMA GENERATOR
ETHICON, INC. 510(k) NO: K131656(TRADITIONAL)
ATTN: SARAH MCMANUS PHONE NO : 908 218 2954
P.O. BOX 151 ROUTE 22 WEST SE DECISION MADE: 27-SEP-13
SOMERVILLE NJ 08876 0151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING
US VASCULAR, LLC 510(k) NO: K131860(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 888 729 9674
1468 HARWELL AVE SE DECISION MADE: 27-SEP-13
CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NMI COAXIAL MICROINTRODUCER SET
NAVILYST MEDICAL, INC. 510(k) NO: K132713(SPECIAL)
ATTN: MICHAEL P HANLEY PHONE NO : 508 658 7983
26 FOREST STREET SE DECISION MADE: 27-SEP-13
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX UNIVERS APEX
ARTHREX, INC. 510(k) NO: K131633(TRADITIONAL)
ATTN: COURTNEY SMITH PHONE NO : 239 643 5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 27-SEP-13
NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF
TYBER MEDICAL LLC 510(k) NO: K130573(TRADITIONAL)
ATTN: JEFF TYBER PHONE NO : 303 717 5060
89 HEADQUARTERS PLAZA NORTH #1464 SE DECISION MADE: 30-SEP-13
MORRISTOWN NJ 07960 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC
ACUMED LLC 510(k) NO: K131845(TRADITIONAL)
ATTN: KARA BUDOR PHONE NO : 503 207 1412
5885 NW CORNELIUS PASS RD. SE DECISION MADE: 30-SEP-13
HILLSBORO OR 97124 9432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIRED MOUTH PROTECTOR (WMP)
ELBA LABORATORIES, INC. 510(k) NO: K131396(TRADITIONAL)
ATTN: RICHARD A HAMER PHONE NO : 248 586 8433
780 W. 8 MILE RD SE DECISION MADE: 30-SEP-13
FERNDALE MI 48220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM
NEOS SURGERY S.L. 510(k) NO: K132044(TRADITIONAL)
ATTN: CHERITA JAMES PHONE NO : 703 562 9800
901 KING STREET SUITE 101 SE DECISION MADE: 30-SEP-13
ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY
BEST MEDICAL INTERNATIONAL, INC. 510(k) NO: K132097(TRADITIONAL)
ATTN: DHARMENDRA THAKUR PHONE NO : 703 451 2378
7643 FULLERTON RD. SE DECISION MADE: 30-SEP-13
SPRINGFIELD VA 22153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHASER HRS2 RX HAIR REMOVAL SYSTEM
SHASER, INC. 510(k) NO: K132266(TRADITIONAL)
ATTN: ANTHONY BURNS PHONE NO : 781 995 2246
10 MAGUIRE RD STE 120 BUILDING ONESE DECISION MADE: 30-SEP-13
LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
