TOTAL 510(k)s THIS PERIOD 224
TOTAL WITH SUMMARIES 212
TOTAL WITH STATEMENTS 12
DEVICE: PREFERRED BLOOD GLUCOSE MONITORING SYSTEM
PRODIGY DIABETES CARE, LLC 510(k) NO: K122338(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 888 729 9674
1468 HARWELL AVENUE SE DECISION MADE: 05-NOV-13
CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNISTRIP 1
UNISTRIP TECHNOLOGIES, LLC 510(k) NO: K113135(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 888 729 9674
1468 HARWELL AVE SE DECISION MADE: 06-NOV-13
CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP
UCP BIOSCIENCES, INC. 510(k) NO: K131236(TRADITIONAL)
ATTN: NANCY CHEN PHONE NO : 408 392 0064
1445 KOLL CIRCLE, STE. 111 SE DECISION MADE: 07-NOV-13
SAN JOSE CA 95112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV
BECTON, DICKINSON AND COMPANY 510(k) NO: K132456(TRADITIONAL)
ATTN: GREGORY P PAYNE, RAC PHONE NO : 858 795 7890
10865 ROAD TO THE CURE SUITE 200 SE DECISION MADE: 07-NOV-13
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS
SIEMENS HELATHCARE DIAGNOSTICS INC510(k) NO: K131275(TRADITIONAL)
ATTN: ELISABETH WARINER PHONE NO : 916 374 3183
1584 ENTERPRISE BLVD. SE DECISION MADE: 08-NOV-13
WEST SACRAMENTO CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
DIASORIN, INC. 510(k) NO: K132515(TRADITIONAL)
ATTN: CAROL A DEPOUW PHONE NO : 651 351 5850
1951 NORTHWESTERN AVE. P.O. BOX 28SE DECISION MADE: 08-NOV-13
STILLWATER MN 55082 0285 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
CO-INNOVATION BIOTECH CO., LTD. 510(k) NO: K132085(TRADITIONAL)
ATTN: HONG FENG PHONE NO : 86 20 62867285
NO. 13 YANYUAN ROAD. TIANHE DISTRISE DECISION MADE: 12-NOV-13
GUANGZHOU, GUANGDONG CH 510507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
OMEGA LABORATORIES, INC. 510(k) NO: K131128(TRADITIONAL)
ATTN: ROBERT J BARD, JD PHONE NO : 248 573 5040
400 NORTH CLEVELAND SE DECISION MADE: 13-NOV-13
MOGADORE OH 44260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GSP NEONATAL BIOTINIDASE KIT
WALLAC OY 510(k) NO: K131284(TRADITIONAL)
ATTN: JEANETTE SCHIER-PUGSLEY PHONE NO : 781 663 6025
940 WINTER STREET SE DECISION MADE: 14-NOV-13
WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST ST MEROPENEM
BIOMERIEUX, INC. 510(k) NO: K132507(TRADITIONAL)
ATTN: NATHAN HARDESTY PHONE NO : 314 731 8666
595 ANGLUM RD. SE DECISION MADE: 15-NOV-13
HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILLUMINA MISEQDX TM CYSTIC FIBROSIS CARRIER SCREEN ASSAY, ILLUMINA MISEQDX TM CYSTIC FIBROSIS DIAGNOSTIC ASSAY
ILLUMINA, INC. 510(k) NO: K124006(TRADITIONAL)
ATTN: LEANNE M KIVIHARJU PHONE NO : 858 202 4500
5200 ILLUMINA WAY SE DECISION MADE: 19-NOV-13
SAN DIEGO CA 92122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILLUMINA MISEQDX(TM) CYSTIC FIBROSIS DIAGNOSTIC ASSAY
ILLUMINA, INC. 510(k) NO: K132750(TRADITIONAL)
ATTN: BRYAN SCHNEIDER PHONE NO : 858 202 4500
5200 ILLUMINA WAY SE DECISION MADE: 19-NOV-13
SAN DIEGO CA 92122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
RANDOX LABORATORIES, LTD. 510(k) NO: K123977(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 44 28 94422413
55 DIAMOND RD. SE DECISION MADE: 21-NOV-13
CRUMLIN, COUNTY ANTRIM UK BT29 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFLAMMADRY EXTERNAL CONTROLS
RAPID PATHOGEN SCREENING, INC. 510(k) NO: K132066(TRADITIONAL)
ATTN: DOUGLAS BUESCHEL PHONE NO : 941 556 1850
7227 DELAINEY COURT SE DECISION MADE: 21-NOV-13
SARASOTA FL 34240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIRTUOSO SYSTEM FOR IHC ER (SPI)
VENTANA MEDICAL SYSTEMS, INC. 510(k) NO: K130515(TRADITIONAL)
ATTN: ERIKA AMMIRATI PHONE NO : 650 949 2768
575 SHIRLYNN COURT SE DECISION MADE: 22-NOV-13
LOS ALTOS CA 94022 510(k) STATEMENT
DEVICE: GLB BENECHECK PREMIUM GLU MONITORING SYSTEM
GENERAL LIFE BIOTECHNOLOGY CO., LT510(k) NO: K123090(TRADITIONAL)
ATTN: FENG-YU LEE PHONE NO : 949 951 3046
27001 LA PAZ ROAD SUITE 266B SE DECISION MADE: 22-NOV-13
MISSION VIEJO CA 92691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K133067(TRADITIONAL)
ATTN: KIRA GORDON PHONE NO : 914 524 2996
511 BENEDICT AVE SE DECISION MADE: 22-NOV-13
TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER, CARESENS N MULTI BLO
I-SENS, INC. 510(k) NO: K132288(SPECIAL)
ATTN: CHAE YUN LIM PHONE NO : 822 91 66191
27-36 GWANGUN-RO, NOWON-GU SE DECISION MADE: 22-NOV-13
SEOUL KS 139-845 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRODIGY CHOICE
PRODIGY DIABETES CARE, LLC 510(k) NO: K122340(TRADITIONAL)
ATTN: E J SMITH PHONE NO : 888 729 9674
1468 HARWELL AVENUE SE DECISION MADE: 26-NOV-13
CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD MAX STAPHSR ASSAY, INSTRUMENT
GENEOHM SCIENCES CANADA, INC. (BD 510(k) NO: K132822(TRADITIONAL)
ATTN: PATRICIA DIONNE PHONE NO : 418 780778 3
2555 BOUL. DU PARC-TECHNOLOGIQUE SE DECISION MADE: 26-NOV-13
QUEBEC CA G1P 4S5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM
PRIMERADX 510(k) NO: K132726(TRADITIONAL)
ATTN: FAYYAZ MEMNON PHONE NO : 508 618 2300
171 FORBES BLVD SUITE 1000 SE DECISION MADE: 29-NOV-13
MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARPATH ALIGNER
QSERVE AMERICA, INC. 510(k) NO: K123514(TRADITIONAL)
ATTN: PATSY TRISLER PHONE NO : 301 652 5344
154 MAIN STREET, STE 2 SE DECISION MADE: 01-NOV-13
CHARLESTOWN NH 03603 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PETITE BASIC SYSTEM 701 ELT
MEGO AFEK AC LTD 510(k) NO: K131420(TRADITIONAL)
ATTN: MARIA GRIFFIN PHONE NO : 516 482 9001
55 NORTHERN BLVD., STE 200 SE DECISION MADE: 01-NOV-13
GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILK ROAD ACCESS CATHETER
SILK ROAD MEDICAL, INC 510(k) NO: K130649(TRADITIONAL)
ATTN: RICHARD M RUEDY PHONE NO : 408 720 9002
735 NORTH PASTORIA AVE SE DECISION MADE: 01-NOV-13
SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCANNING LASERLINK
LUMENIS, INC. 510(k) NO: K130195(ABBREVIATED)
ATTN: JACE R MCLANE PHONE NO : 801 656 2328
3959 WEST 1820 SOUTH SE DECISION MADE: 01-NOV-13
SALT LAKE CITY UT 84104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND
KURARAY NORITAKE DENTAL INC. 510(k) NO: K132450(TRADITIONAL)
ATTN: MICHIO TAKIGAWA PHONE NO : 813 67 011706
OTE CENTER BLDG 7F 1-1-3, OTEMACHISE DECISION MADE: 01-NOV-13
CHIYODA-KU JA 100-0004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUIET/SILENT SCANNING SUITE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132831(TRADITIONAL)
ATTN: NADIA SOOKDEO PHONE NO : 610 448 4918
51 VALLEY STREAM PARKWAY SE DECISION MADE: 01-NOV-13
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIMETER INTERBODY FUSION DEVICE
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K131669(TRADITIONAL)
ATTN: LAUREN KAMER PHONE NO : 901 396 3133
1800 PYRAMID PLACE SE DECISION MADE: 01-NOV-13
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAYSCAN A-EXPERT
RAY CO., LTD 510(k) NO: K131693(SPECIAL)
ATTN: ANDREW PAENG PHONE NO : 317 363 1000
4747 HOEN AVE. SE DECISION MADE: 01-NOV-13
SANTA ROSA CA 95405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAYSCAN A-EXPERT 3D
RAY CO., LTD 510(k) NO: K131695(SPECIAL)
ATTN: ANDREW PAENG PHONE NO : 317 363 1000
4747 HOEN AVE. SE DECISION MADE: 01-NOV-13
SANTA ROSA CA 95405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENAMELAST
ULTRADENT PRODUCTS INC. / ORATECH 510(k) NO: K132109(TRADITIONAL)
ATTN: KAREN KAKUNES PHONE NO : 801 553 4366
505 W 10200 S SE DECISION MADE: 01-NOV-13
SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLARITY VACUUM BAG, KLARITY MOLD CUSHION
KLARITY MEDICAL PRODUCTS, LLC 510(k) NO: K132124(TRADITIONAL)
ATTN: PETER LARSON PHONE NO : 740 788 8107
80 WESTGATE DRIVE SE DECISION MADE: 01-NOV-13
NEWARK OH 43055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)
HEMODIA S.A.S. 510(k) NO: K132883(TRADITIONAL)
ATTN: REMI TEULIERE PHONE NO : 33 561 007181
85 DU CHENE VERT SE DECISION MADE: 01-NOV-13
LABEGE FR 31670 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW
AMBU A/S 510(k) NO: K130845(TRADITIONAL)
ATTN: SANJAY PARIKH PHONE NO : 410 768 6464
6740 BAYMEADOW DR. SE DECISION MADE: 01-NOV-13
GLEN BURNIE MD 21060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIX HAND SYSTEM
JEIL MEDICAL CORPORATION 510(k) NO: K131566(TRADITIONAL)
ATTN: JI-EUN KIM PHONE NO : 82 2 8503500
#702, KOLON SCIENCE VALLEY 2ND 811SE DECISION MADE: 04-NOV-13
SEOUL-CITY KS 152-050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES
BOSTON SCIENTIFIC CORP. 510(k) NO: K131700(TRADITIONAL)
ATTN: JANIS F TARANTO PHONE NO : 508 683 4560
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 04-NOV-13
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTHOUSE(TM) URINARY CATHETER
SEEDINGS LIFE SCIENCE VENTURES, LL510(k) NO: K131655(TRADITIONAL)
ATTN: KEN SOLOVAY PHONE NO : 954 336 0777
230 EAST 15TH STREET SUITE 1-A SE DECISION MADE: 04-NOV-13
NEW YORK NY 10003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WOLF LONG BONE PLATE SYSTEM
TOBY ORTHOPAEDICS 510(k) NO: K131834(TRADITIONAL)
ATTN: ERIC NEYHARD PHONE NO : 305 665 8699
401 SW 42nd Ave Suite 200 SE DECISION MADE: 04-NOV-13
Miami FL 33134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MECTACER BIOLOX OPTION HEADS
MEDACTA INTERNATIONAL 510(k) NO: K131518(TRADITIONAL)
ATTN: ADAM GROSS PHONE NO : 805 322 3289
4725 CALLE QUETZAL, UNIT B SE DECISION MADE: 04-NOV-13
CAMARILLO CA 93012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-PORTE ULTRASOUND SYSTEM
FUJIFILM SONOSITE,INC. 510(k) NO: K133134(TRADITIONAL)
ATTN: SCOTT PAULSON PHONE NO : 425 951 6926
21919 30th Dr SE SE DECISION MADE: 04-NOV-13
BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CARDIOX FLOW DETECTION SYSTEM
CARDIOX CORP. 510(k) NO: K122400(TRADITIONAL)
ATTN: KAREN MATIS PHONE NO : 614 791 8118
4100 HORIZONS DRIVE, SUITE 100 SE DECISION MADE: 05-NOV-13
COLUMBUS OH 43220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DICOMPACS DX-R WITH FLAT PANEL
OEHM UND REHBEIN GMBH 510(k) NO: K131211(TRADITIONAL)
ATTN: FRANZISKA GUENTHER PHONE NO : 49 38136 600500
NEPTUNALLEE 7C SE DECISION MADE: 05-NOV-13
ROCKSTOCK GM 18057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDA LED SURGICAL LIGHTING SYSTEM
CONVIDA HEALTHCARE & SYSTEMS CORPO510(k) NO: K132307(TRADITIONAL)
ATTN: RYAN HUNG PHONE NO : 886 331837 77
2F AND B2, NO.33, DINGHU RD GUISHASE DECISION MADE: 05-NOV-13
TAOYUAN COUNTY TW 33378 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEMILLS VALVULOTOME
LEMAITRE VASCULAR, INC. 510(k) NO: K132047(TRADITIONAL)
ATTN: ANDREW HODGKINSON PHONE NO : 781 221 2266
63 SECOND AVENUE SE DECISION MADE: 05-NOV-13
BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EM SINUS DILATION SYSTEM
MEDTRONIC XOMED, INC. 510(k) NO: K132297(TRADITIONAL)
ATTN: ROZANNE PACIEJ PHONE NO : 904 332 8233
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 05-NOV-13
JACKSONVILLE FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN
COVIDIEN 510(k) NO: K132567(SPECIAL)
ATTN: DOLLY MISTRY PHONE NO : 508 452 1646
15 HAMPSHIRE STREET SE DECISION MADE: 05-NOV-13
MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY – HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K132241(TRADITIONAL)
ATTN: YAYORI FUJIMAKI PHONE NO : 508 828 3541
325 PARAMOUNT DR. SE DECISION MADE: 05-NOV-13
RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NURO NEUROMODULATION SYSTEM
ADVANCED URO-SOLUTIONS, INC. 510(k) NO: K132561(TRADITIONAL)
ATTN: PENNY NORTHCUTT PHONE NO : 678 428 6978
717 LAKEGLEN DRIVE SE DECISION MADE: 05-NOV-13
SUWANEE GA 30024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFUSION SYRINGE SET
INNOVATIVE MEDICAL MANUFACTURING C510(k) NO: K131661(TRADITIONAL)
ATTN: LUCY HUANG PHONE NO : 011 886376 20236
107, LANE 181, SEC. 1 YONG JANE ROSE DECISION MADE: 05-NOV-13
CHUNAN, MIAOLI TW 350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH
COVIDIEN LLC 510(k) NO: K130357(TRADITIONAL)
ATTN: KRISTEN SWANSON PHONE NO : 763 210 4062
161 CHESHIRE LANE STE 100 SE DECISION MADE: 06-NOV-13
MINNEAPOLIS MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET
TELEFLEX MEDICAL 510(k) NO: K130405(TRADITIONAL)
ATTN: LORI PFOHL PHONE NO : 919 491 8960
2917 WECK DR. SE DECISION MADE: 06-NOV-13
RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
GENORAY CO., LTD. 510(k) NO: K130419(TRADITIONAL)
ATTN: JAE KIM PHONE NO : 855 436 6729
1073 N. BATAVIA ST SE DECISION MADE: 06-NOV-13
ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEMAITRE 8F OCCLUSION CATHETER
LEMAITRE VASCULAR, INC. 510(k) NO: K132022(TRADITIONAL)
ATTN: ANDREW HODGKINSON PHONE NO : 781 221 2266
63 2ND AVENUE SE DECISION MADE: 06-NOV-13
BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET
MOLNLYCKE HEALTH CARE US, LLC 510(k) NO: K132048(TRADITIONAL)
ATTN: CURTIS D TRUESDALE PHONE NO : 678 250 7829
5550 PEACHTREE PARKWAY SUITE 500 SE DECISION MADE: 06-NOV-13
NORCROSS GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELMONT HYPERTHERMIA PUMP
BELMONT INSTRUMENT CORP. 510(k) NO: K131519(SPECIAL)
ATTN: SABRINA BELLADUE PHONE NO : 978 663 0212
780 BOSTON RD. SE DECISION MADE: 06-NOV-13
BILLERICA MA 01821 510(k) STATEMENT
DEVICE: G-ARM MULTISCAN SYSTEM
BEIJING EAST WHALE IMAGING TECHNOL510(k) NO: K131423(TRADITIONAL)
ATTN: BETTER LI PHONE NO : 86 10678 92701-838
NO. 2 WORKSHOP BLDG 2, NO 9 KECHUASE DECISION MADE: 07-NOV-13
BEIJING CH 100023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT
COCHLEAR AMERICAS 510(k) NO: K131240(TRADITIONAL)
ATTN: SEAN BUNDY PHONE NO : 800 523 5798
13059 EAST PEAKVIEW AVENUE SE DECISION MADE: 07-NOV-13
CENTENNIAL CO 80111 510(k) STATEMENT
DEVICE: CONCEIVE PLUS
SASMAR INC 510(k) NO: K131355(TRADITIONAL)
ATTN: JOHN-MICHAEL MANCINI PHONE NO : 773 942 0030
155 NORTH WACKER DR, STE 4250 SE DECISION MADE: 07-NOV-13
CHICAGO IL 60606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE
KIMBERLY-CLARK CORP. 510(k) NO: K131841(TRADITIONAL)
ATTN: CHRISTINE L MACAULEY PHONE NO : 770 587 8638
1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 07-NOV-13
ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUILION ONE VISION, V6.0
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K132222(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714 669 7808
2441 MICHELLE DRIVE SE DECISION MADE: 07-NOV-13
TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLARISO PACS
CLARISO, INC. 510(k) NO: K132799(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 469 684 1980
111 MELANIE DRIVE SE DECISION MADE: 07-NOV-13
AUBREY TX 76227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DC 7
DC INTERNATIONAL, LLC 510(k) NO: K131839(TRADITIONAL)
ATTN: DAVID BOEGLER PHONE NO : 561 337 8888
624 CYPRESS GREEN CIR. SE DECISION MADE: 07-NOV-13
WELLINGTON FL 33414 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAPLP ASPIRATION CATHETER
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K132155(TRADITIONAL)
ATTN: SUSAN CHRISTENSEN PHONE NO : 801 208 4789
1600 WEST MERIT PKWY. SE DECISION MADE: 07-NOV-13
SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOALIGN PLUS SYSTEM
ORTHALIGN, INC 510(k) NO: K130387(TRADITIONAL)
ATTN: AMY WALTERS PHONE NO : 949 923 9400
338 VISTA MADERA SE DECISION MADE: 08-NOV-13
NEWPORT BEACH CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-Y BRAND LIQUIBEADS
JOHNSON & JOHNSON HEALTHCARE PRODU510(k) NO: K122061(TRADITIONAL)
ATTN: LORNA-JANE BREMER PHONE NO : 973 385 0557
185 TABOR ROAD SE DECISION MADE: 08-NOV-13
MORRIS PLAINS NJ 07950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BYTECH
BYTECH DONGTAI CO., LTD. 510(k) NO: K130101(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441
RM 1606 BUILDING 1 JIAN XIANG YUANSE DECISION MADE: 08-NOV-13
BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10
GE HEALTHCARE 510(k) NO: K132913(SPECIAL)
ATTN: BRYAN BEHN PHONE NO : 414 721 4214
9900 W INNOVATION DRIVE SE DECISION MADE: 08-NOV-13
WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APNEALINK PRO
RESMED GERMANY INC. 510(k) NO: K131932(TRADITIONAL)
ATTN: SANDRA GRUNWALD PHONE NO : 49 899 90100
FRAUNHOFERSTRASSE 16 SE DECISION MADE: 08-NOV-13
MARTINSRIED GM D-82152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
ORTHOSENSOR, INC. 510(k) NO: K131767(SPECIAL)
ATTN: MARTHA I GARAY PHONE NO : 954 577 7770
1855 GRIFFIN ROAD SUITE A-310 SE DECISION MADE: 08-NOV-13
DANIA BEACH FL 33004 2200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASS LP SPINAL SYSTEM
MEDICREA INTERNATIONAL 510(k) NO: K132574(TRADITIONAL)
ATTN: AUDREY VION PHONE NO : 33 47 2018787
14 Porte du Grand Lyon SE DECISION MADE: 08-NOV-13
NEYRON FR 01700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIVALVE ACWIRE
MEDIVALVE LTD. 510(k) NO: K132545(TRADITIONAL)
ATTN: LEO BASTA PHONE NO : 617 834 9866
93 BENEFIT STREET SE DECISION MADE: 08-NOV-13
PROVIDENCE RI 02904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUMELOCK II CEMENTLESS SHOULDER SYSTEM
FX SOLUTIONS 510(k) NO: K130759(TRADITIONAL)
ATTN: JEAN-JACQUES MARTIN PHONE NO : 33 474 553555
1663 RUE DE MAJORNAS SE DECISION MADE: 09-NOV-13
VIRIAT FR 01440 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAYMAN MI PLATE SYSTEM
K2M, INC. 510(k) NO: K131533(TRADITIONAL)
ATTN: NANCY GIEZEN PHONE NO : 703 777 3155
751 MILLER DR., S.E., SUITE F1 SE DECISION MADE: 09-NOV-13
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRUM SPINE SPINOUS PROCESS DEVICE
SPECTRUM SPINE IP HOLDINGS, LLC 510(k) NO: K130066(TRADITIONAL)
ATTN: RICH JANSEN PHONE NO : 612 281 5505
13540 GUILD AVE SE DECISION MADE: 12-NOV-13
APPLE VALLEY MN 55124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHANGHAI PHOENIX MECHANICAL WHEELCHAIR
SHANGHAI PHOENIX MEDICAL EQUIPMENT510(k) NO: K130848(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 86 216722 1555
No.188, Zhongfa Road Zhujing IndusSE DECISION MADE: 12-NOV-13
Jinshan District, Shanghai CN 2510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-CONTACT INFRARED THERMOMETER
SHENZHEN JUMPER MEDICAL EQUIPMENT 510(k) NO: K131243(TRADITIONAL)
ATTN: FIELD FU PHONE NO : 86 755 86069197
4TH FLOOR, JINHUI BLDG, NANHAI BLVSE DECISION MADE: 12-NOV-13
SHENZHEN, GUANGDON CH 518052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I RUNE (I-200L)
MEDIRUNE CO, LTD 510(k) NO: K122410(TRADITIONAL)
ATTN: YANG HO DONG PHONE NO : 082 256633 60
821 SAMIL PLAZA 837-26 YEUKSAM-DONSE DECISION MADE: 12-NOV-13
GANGNAM-GU KS 135-768 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOGRAPH MMR
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133226(SPECIAL)
ATTN: NADIA SOOKDEO PHONE NO : 610 448 4918
51 VALLEY STREAM PKWY. SE DECISION MADE: 12-NOV-13
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINIX ANGIO WORKSTATION W/DTS SOFTWARE
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K132106(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714 669 7808
2441 MICHELLE DR. SE DECISION MADE: 12-NOV-13
TUSTIN CA 92780 2068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS
RADIOLOGY SOLUTIONS LLC 510(k) NO: K132294(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 12-NOV-13
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUADROX-IR ADULT AND SMALL ADULT
MAQUET CARDIOPULMONARY AG 510(k) NO: K133265(SPECIAL)
ATTN: WHITNEY TORNING PHONE NO : 973 709 7994
45 BARBOUR POND DRIVE SE DECISION MADE: 12-NOV-13
WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BECE CAD ZIRKON HT+
BEGO BREMER GOLDSCHLAEGEREI WILH. 510(k) NO: K132102(TRADITIONAL)
ATTN: HEIKE GUSTKE PHONE NO : 49 421 2028112
WILHELM-HERBST-STRASSE 1 SE DECISION MADE: 12-NOV-13
BREMEN GM 28359 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML
HOSPIRA, INC. 510(k) NO: K132276(TRADITIONAL)
ATTN: ABIGAIL FERGUSON PHONE NO : 224 212 6162
275 NORTH FIELD DR. SE DECISION MADE: 12-NOV-13
LAKE FOREST IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KULAVAC
CGBIO CO., LTD 510(k) NO: K122490(TRADITIONAL)
ATTN: JUNGEUN IM PHONE NO : 822 205 91675
163-3 SAMSUNG-DONG KANGNAM-GU SE DECISION MADE: 13-NOV-13
SEOUL KS 135-715 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDYS(TM) C
CLARIANCE 510(k) NO: K130853(TRADITIONAL)
ATTN: JANICE M HOGAN PHONE NO : 267 675 4611
1835 MARKET STREET 29TH FLOOR SE DECISION MADE: 13-NOV-13
PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS
MEDICAL DEVELOPMENTS INTERNATIONAL510(k) NO: K122252(TRADITIONAL)
ATTN: TRACEY BULLIVANT PHONE NO : 612 990 62984
SUITE 408, 460 PACIFIC HIGHWAY SE DECISION MADE: 13-NOV-13
ST LEONARDS AS 2065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA
AMERIWATER 510(k) NO: K131904(TRADITIONAL)
ATTN: BRIAN R BOWMAN PHONE NO : 937 461 8833
1303 STANLEY AVE. SE DECISION MADE: 13-NOV-13
DAYTON OH 45404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U&U STERILE HYPODERMIC NEEDLE
U&U MEDICAL TECHNOLOGY CO., LTD 510(k) NO: K132552(TRADITIONAL)
ATTN: XUEBO WANG PHONE NO : 86 1356 4751751
DONGZHOU VILLAGE, HENGSHANQIAO SE DECISION MADE: 13-NOV-13
CHANGZHOU, JIANGSU CH 213119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
BECTON DICKINSON & CO. 510(k) NO: K133138(SPECIAL)
ATTN: GREGORY P PAYNE PHONE NO : 858 795 7890
10865 ROAD TO THE CURE, SUITE 200 SE DECISION MADE: 13-NOV-13
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERIDIAN
AB ARDENT 510(k) NO: K131753(ABBREVIATED)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716 691 0010
175 PINEVIEW DRIVE SE DECISION MADE: 14-NOV-13
AMHERST NY 14228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSCH BLOOD PRESSURE METER (BP5000 BT)
ROBERT BOSCH HEALTHCARE SYSTEMS, I510(k) NO: K131026(TRADITIONAL)
ATTN: LOUISE MUSANTE PHONE NO : 650 690 9167
2400 Geng Rd Ste 200 SE DECISION MADE: 14-NOV-13
Palo Alto CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL ELECTROCARDIOGRAPHS
SONOSCAPE COMPANY LIMITED 510(k) NO: K131262(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 22815850
P.O. BOX 120-119 SE DECISION MADE: 14-NOV-13
SHANGHAI CH 237-023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANKER DENTAL IMPLANT SYSTEM
ALLIANCE GLOBAL 510(k) NO: K131165(TRADITIONAL)
ATTN: YAYUAN CHANG PHONE NO : 866 7695 6688
2F., NO.92, LUKE 5TH RD., LUZHU DISE DECISION MADE: 14-NOV-13
KAOHSIUNG CITY TW 82151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEREGRINE CURVED ILLUMINATING LASER PROBE
PEREGRINE SURGICAL, LTD. 510(k) NO: K132614(SPECIAL)
ATTN: RYAN O’LEARY PHONE NO : 215 348 0456
51 Britain Drive SE DECISION MADE: 14-NOV-13
Doylestown PA 18901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT
MAQUET CARDIOVASCULAR LLC 510(k) NO: K131778(TRADITIONAL)
ATTN: MARYLOU INSINGA PHONE NO : 973 709 7442
45 BARBOUR POND DRIVE SE DECISION MADE: 14-NOV-13
Wayne NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
BOSTON SCIENTIFIC CORP. 510(k) NO: K133208(SPECIAL)
ATTN: MAUREEN SUNDEEN PHONE NO : 763 494 2903
ONE SCIMED PLACE SE DECISION MADE: 14-NOV-13
MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOSIMETRY CHECK VERSION 4 RELEASE 1
MATH RESOLUTIONS, LLC. 510(k) NO: K132605(TRADITIONAL)
ATTN: WENDEL DEAN RENNER PHONE NO : 410 997 9578
5975 GALES LN. SE DECISION MADE: 14-NOV-13
COLUMBIA MD 21045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL COLOR DOPPLER ULTASOUND SYSTEM
SONOSCAPE COMPANY LIMITED 510(k) NO: K132527(TRADITIONAL)
ATTN: TOKI WU PHONE NO : 86 755267 22890
YIZHE BLDG., YUQUAN RD SE DECISION MADE: 14-NOV-13
SHENZHEN, GUANGDONG CH 518051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS
IQ IMPLANTS LTD. 510(k) NO: K130829(TRADITIONAL)
ATTN: NATALIA DINERSTHEIN PHONE NO : 972 8 6233568
TAASHUR 9 SE DECISION MADE: 14-NOV-13
OMER IS 84965 510(k) STATEMENT
DEVICE: MAGNETOM AERA
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132951(SPECIAL)
ATTN: NADIA SOOKDEO PHONE NO : 610 448 4918
51 VALLEY STREAM PARKWAY SE DECISION MADE: 15-NOV-13
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPM-300
BIONET CO., LTD. 510(k) NO: K130322(TRADITIONAL)
ATTN: MARC GOODMAN PHONE NO : 949 398 5222
5405 ALTON PARKWAY, SUITE A530 SE DECISION MADE: 15-NOV-13
IRVINE CA 92604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYMPHONY RF GENERATOR
THERMIGEN, INC. 510(k) NO: K130689(TRADITIONAL)
ATTN: KEVIN O’BRIEN PHONE NO : 214 621 2525
401 N. CARROLL AVE SE DECISION MADE: 15-NOV-13
SOUTHLAKE TX 76092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOVEIL
GUNZE LIMITED 510(k) NO: K130997(TRADITIONAL)
ATTN: NOBUYA ONISHI PHONE NO : 817 734280 35
46 NATSUMEGAICHI, AONO SE DECISION MADE: 15-NOV-13
AYABE, KYOTO JA 623-8513 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOLITH TOUCH; URO TOUCH
NORTHGATE TECHNOLOGIES INC. 510(k) NO: K130368(TRADITIONAL)
ATTN: CASEY KUREK PHONE NO : 224 856 2222
1591 Scottsdale Court SE DECISION MADE: 15-NOV-13
Elgin IL 60123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSGATE GUIDE CATHETER
STRYKER NEUROVASCULAR 510(k) NO: K132542(TRADITIONAL)
ATTN: ANJALI ATAL-GUPTA PHONE NO : 510 413 2500
47900 BAYSIDE PARKWAY SE DECISION MADE: 15-NOV-13
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRONIC PULSE MASSAGER
SHENZHEN JINGKEHUI ELECTRONIC CO.,510(k) NO: K131921(TRADITIONAL)
ATTN: BILL DAI PHONE NO : 508 723 6334
513 PIAZZA DR. UNIT B SE DECISION MADE: 15-NOV-13
MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHARPSOLOGY 2
INDUSTRIAL WATER SOLUTIONS, INC. 510(k) NO: K133031(TRADITIONAL)
ATTN: THOMAS P STEWART PHONE NO : 540 520 6341
2692 WILLOWLAWN STREET, S.W. SE DECISION MADE: 15-NOV-13
Roanoke VA 24018 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T
GE HEALTHCARE (GE MEDICAL SYSTEMS,510(k) NO: K132376(TRADITIONAL)
ATTN: MICHELLE HUETTNER PHONE NO : 262 521 6102
3200 N. GRANDVIEW BLVD SE DECISION MADE: 15-NOV-13
WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ND NABIL DIB INFUSION CATHETER
TRANSLATIONAL RESEARCH INSTITUTE 510(k) NO: K130569(TRADITIONAL)
ATTN: DEANN DANA PHONE NO : 480 612 0640
3420 S MERCY RD #312 SE DECISION MADE: 15-NOV-13
GILBERT AZ 85297 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
BECTON DICKINSON & CO. 510(k) NO: K133140(SPECIAL)
ATTN: GREGORY P PAYNE PHONE NO : 858 795 7890
10865 ROAD TO THE CURE, SUITE 200 SE DECISION MADE: 15-NOV-13
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROCYN SCAR MANAGEMENT HYDROGEL
OCULUS INNOVATIVE SCIENCES 510(k) NO: K131672(TRADITIONAL)
ATTN: BRIAN W MARTIN PHONE NO : 707 283 0550
1129 N MCDOWELL BLVD SE DECISION MADE: 15-NOV-13
PETALUMA CA 94954 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENSYN BAND
DALLEN MEDICAL, INC. 510(k) NO: K131850(TRADITIONAL)
ATTN: AL MEMMOLO PHONE NO : 949 218 0030
1046 Calle Recodo Ste G SE DECISION MADE: 15-NOV-13
San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION
VOLCANO CORPORATION 510(k) NO: K133142(SPECIAL)
ATTN: ELAINE ALAN PHONE NO : 978 439 3357
1 FORTUNE DR SE DECISION MADE: 15-NOV-13
BILLERICA MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM
KCI USA, INC. 510(k) NO: K132741(SPECIAL)
ATTN: MELANIE AVILA PHONE NO : 210 515 4059
6203 FARINON DR. SE DECISION MADE: 15-NOV-13
SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)
GE MEDICAL SYSTEMS, LLC 510(k) NO: K132261(TRADITIONAL)
ATTN: JOHN L SCHMIDT PHONE NO : 262 548 4964
3000 N GRANDVIEW BLVD. SE DECISION MADE: 18-NOV-13
WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRITY SPINE CORE SYSTEM
INTEGRITY SPINE 510(k) NO: K132718(TRADITIONAL)
ATTN: LISA PETERSON PHONE NO : 512 507 0746
14001 HUNTERS PASS SE DECISION MADE: 18-NOV-13
AUSTIN TX 78734 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)
STRYKER SPINE 510(k) NO: K132968(TRADITIONAL)
ATTN: KRISTEN MEANY, MS, CQA, RACPHONE NO : 201 760 8070
2 PEARL COURT SE DECISION MADE: 18-NOV-13
ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA FACET FIXATION SYSTEM
SEASPINE, INC. 510(k) NO: K132859(TRADITIONAL)
ATTN: MICHELLE WILLIS PHONE NO : 760 216 5104
2302 LA MIRADA DR. SE DECISION MADE: 18-NOV-13
VISTA CA 92081 7862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5
AAP IMPLANTATE AG 510(k) NO: K131782(TRADITIONAL)
ATTN: CHRISTIAN ZIETSCH PHONE NO : 49 307501 9193
LORENZWEG 5 SE DECISION MADE: 18-NOV-13
BERLIN GM 12099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOWER ANKLE PLATING SET
FLOWER ORTHOPEDICS CORPORATION 510(k) NO: K133102(TRADITIONAL)
ATTN: JANICE M HOGAN PHONE NO : 267 675 4611
1835 MARKET ST, 29TH FLOOR SE DECISION MADE: 18-NOV-13
PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT
ARTHROSURFACE, INC. 510(k) NO: K131377(TRADITIONAL)
ATTN: DAWN J WILSON PHONE NO : 508 520 3003
28 FORGE PARKWAY SE DECISION MADE: 19-NOV-13
FRANKLIN MA 02038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUMITOMO PROTON THERAPY SYSTEM
SUMITOMO HEAVY INDUSTRIES, LTD 510(k) NO: K130426(TRADITIONAL)
ATTN: RONALD S WARREN PHONE NO : 858 753 1961
11440 W. BERNARDO COURT SUITE 300 SE DECISION MADE: 19-NOV-13
SAN DIEGO CA 92127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARACE MD EKOSCOPE IS100
PARACE LLC 510(k) NO: K123148(TRADITIONAL)
ATTN: VANDETTE CARTER PHONE NO : 914 356 4848
PO BOX 171 SE DECISION MADE: 19-NOV-13
YORKTOWN HEIGHTS NY 10598 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM
ZIMMER DENTAL INC. 510(k) NO: K132258(TRADITIONAL)
ATTN: JULIE L CORMAN PHONE NO : 760 929 4300
1900 ASTON AVE. SE DECISION MADE: 19-NOV-13
CARLSBAD CA 92008 7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER
MEDTRONIC INC. 510(k) NO: K132712(TRADITIONAL)
ATTN: LISA STONE PHONE NO : 763 514 9866
8200 CORAL SEA STREET NE SE DECISION MADE: 19-NOV-13
MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K132779(TRADITIONAL)
ATTN: PHONE NO :
MINDRAY BLDG. KEJI 12TH RD S. HI-TSE DECISION MADE: 19-NOV-13
NANSHAN, SHENZHEN CH 518057 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS
KCI USA, INC. 510(k) NO: K133276(SPECIAL)
ATTN: MELANIE AVILA PHONE NO : 210 515 4059
6203 FARINON DR. SE DECISION MADE: 19-NOV-13
SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A.L.P.S. CALCANEAL PLATING SYSTEM
BIOMET MANUFACTURING CORP. 510(k) NO: K132898(TRADITIONAL)
ATTN: JARED COOPER PHONE NO : 574 372 1941
56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 19-NOV-13
WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE
WUXI YUSHOU MEDICAL APPLICANCES CO510(k) NO: K130212(TRADITIONAL)
ATTN: GARFIELD WANG PHONE NO : 86 510 83777555
215# XIGANG ROAD DONGBEITANG SE DECISION MADE: 20-NOV-13
WUXI CITY, JINGSU CH 214191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISIRONA MAGELLAN
ISIRONA, LLC 510(k) NO: K130707(TRADITIONAL)
ATTN: THOMAS KROENKE PHONE NO : 303 956 4232
PO BOX 3018 SE DECISION MADE: 20-NOV-13
NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES
WUXI YUSHOU MEDICAL APPLICANCES CO510(k) NO: K130230(TRADITIONAL)
ATTN: GARFIELD WANG PHONE NO : 86 510 83777555
215# XIGANG ROAD DONGBEITANG SE DECISION MADE: 20-NOV-13
WUXI CITY, JIANGSU CH 214191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAMILTON-MR1
HAMILTON MEDICAL AG 510(k) NO: K122438(ABBREVIATED)
ATTN: RALPH AGUILA PHONE NO : 418 166 06845
VIA CRUSCH 8 SE DECISION MADE: 20-NOV-13
BONADUZ SZ CH-7402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WRIGHT GRADIENT 52 – TORSO
WRIGHT THERAPY PRODUCTS, INC 510(k) NO: K131387(TRADITIONAL)
ATTN: CAROL WRIGHT PHONE NO : 800 631 9535
103-B INTERNATIONAL DR. SE DECISION MADE: 20-NOV-13
OAKDALE PA 15071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRI MARKER
C4 IMAGING LLC 510(k) NO: K131689(TRADITIONAL)
ATTN: STEPHEN J GOLDNER, JD, RAC PHONE NO : 248 747 8008
2550 SOUTH TELEGRAPH ROAD SUITE 10SE DECISION MADE: 20-NOV-13
BLOOMFIELD HILLS MI 48302 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONACO
IMPAC MEDICAL SYSTEMS, INC. 510(k) NO: K132971(TRADITIONAL)
ATTN: KATHRYN STINSON PHONE NO : 314 993 0003
13723 Riverport Drive Suite 100 SE DECISION MADE: 20-NOV-13
Maryland Heights MO 63139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX SPINE SYSTEM
SPINECRAFT LLC 510(k) NO: K132603(TRADITIONAL)
ATTN: AMI AKALLAL-ASAAD PHONE NO : 630 920 7300
777 OAKMONT LANE SE DECISION MADE: 20-NOV-13
WESTMONT IL 60559 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRONCHOSCOPY ELBOW
RESPIRONICS, INC. 510(k) NO: K132168(TRADITIONAL)
ATTN: COLLEEN WITT PHONE NO : 724 387 4146
365 PLUM INDUSTRIAL COURT SE DECISION MADE: 20-NOV-13
PITTSBURGH PA 15239 510(k) STATEMENT
DEVICE: I2C
ION BEAM APPLICATIONS S.A. 510(k) NO: K132847(TRADITIONAL)
ATTN: BRUCE D ARMON PHONE NO : 215 972 7124
1500 MARKET STREET CENTRE SQUARE WSE DECISION MADE: 20-NOV-13
PHILADELPHIA PA 19102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED,
BEACON ENDOSCOPIC 510(k) NO: K133008(TRADITIONAL)
ATTN: ANNETTE M FAGNANT PHONE NO : 617 965 7111
2000 Commonwealth Ave Ste 110 SE DECISION MADE: 20-NOV-13
Auburndale MA 02466 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTICAM 3000 ECO
INTER MEDICAL MEDIZINTECHNIK GMBH 510(k) NO: K132347(TRADITIONAL)
ATTN: WILLIAM CARROLL PHONE NO : 203 483 0665
14 COMMERCIAL ST, UNIT B SE DECISION MADE: 20-NOV-13
BRANFORD CT 06405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETROARC RETROPUBIC SLING SYSTEM
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K132655(TRADITIONAL)
ATTN: RENEE MELLUM PHONE NO : 952 930 6458
10700 BREN RD., WEST SE DECISION MADE: 20-NOV-13
MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR
WELCH ALLYN, INC. 510(k) NO: K132808(SPECIAL)
ATTN: KEVIN CROSSEN PHONE NO : 315 685 2609
4341 STATE ST. RD. P.O. BOX 220 SE DECISION MADE: 20-NOV-13
SKANEATELES FALLS NY 13153 0220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGAMATRIX HEALTH MANAGER
AGAMATRIX INC 510(k) NO: K132821(SPECIAL)
ATTN: WILLIAM H MCGRAIL PHONE NO : 603 328 6051
7C RAYMOND AVE SE DECISION MADE: 20-NOV-13
SALEM NH 03079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NMI PICC III
NAVILYST MEDICAL, INC. 510(k) NO: K133264(SPECIAL)
ATTN: BRANDON BRACKETT PHONE NO : 508 658 7984
26 FOREST STREET SE DECISION MADE: 20-NOV-13
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDGE ORTHOPAEDICS BITE COMPRESSION SCREW
ICON ORTHOPAEDIC CONCEPTS DBA EDGE510(k) NO: K132893(TRADITIONAL)
ATTN: JAN TRIANI PHONE NO : 201 543 9388
6 MARS COURT UNIT 6-3 SE DECISION MADE: 20-NOV-13
BOONTON NJ 07005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVEREST SPINAL SYSTEM
K2M, INC. 510(k) NO: K132757(TRADITIONAL)
ATTN: NANCY GIEZEN PHONE NO : 703 777 3155
751 MILLER DR.,SE SE DECISION MADE: 20-NOV-13
LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFIX II SPINOUS PROCESS PLATE SYSTEM
NUVASIVE, INCORPORATED 510(k) NO: K132411(TRADITIONAL)
ATTN: OLGA LEWIS PHONE NO : 858 320 5257
7475 LUSK BOULEVARD SE DECISION MADE: 20-NOV-13
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT
AUDIFON-USA INC. 510(k) NO: K130514(ABBREVIATED)
ATTN: JANE E PERRONE PHONE NO : 386 668 8812
403 CHAIRMAN COURT, STE. 1 SE DECISION MADE: 21-NOV-13
DEBARY FL 32713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE
PERSYST DEVELOPMENT CORP. 510(k) NO: K132306(TRADITIONAL)
ATTN: DARI DARABBEIGI PHONE NO : 858 461 4542
12625 HIGH BLUFF DRIVE SUITE 213 SE DECISION MADE: 21-NOV-13
SAN DIEGO CA 92130 510(k) STATEMENT
DEVICE: MALDI BIOTYPER CA (MBT-CA) SYSTEM
BRUKER DALTONICS, INC 510(k) NO: K130831(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978 927 3808
180 CABOT STREET SE DECISION MADE: 21-NOV-13
BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PC ECG
EDAN INSTRUMENTS, INC. 510(k) NO: K131819(TRADITIONAL)
ATTN: QUEENA CHEN PHONE NO : 867 55 26858736
EQUIPMENTS PARK, NANHAI RD 1019 NOSE DECISION MADE: 22-NOV-13
SHENZHEN CH 518067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REDSENSE ALARM SYSTEM
REDSENSE MEDICAL AB 510(k) NO: K130554(TRADITIONAL)
ATTN: PATRIK BYHMER PHONE NO : 49 7035 72164
GYLLENHAMMARS VAG 26 SE DECISION MADE: 22-NOV-13
HALMSTAD SW 30292 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREATH SHAKE
CHEEN HOUNG ENT. CO. LTD. 510(k) NO: K121587(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
24301 WOODSAGE DRIVE SE DECISION MADE: 22-NOV-13
BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTOMAG BONE CONDUCATION HEARING SYSTEM
SOPHONO, INC 510(k) NO: K132189(TRADITIONAL)
ATTN: KRISTA B TRAYNOR PHONE NO : 720 407 5160
5744 CENTRAL AVENUE #100 SE DECISION MADE: 22-NOV-13
BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIEZON 150
E.M.S. ELECTRO MEDICAL SYSTEMS S.A510(k) NO: K132443(SPECIAL)
ATTN: CYNTHIA NOLTE PHONE NO : 919 859 4207
62 FOREST ST., STE 300 SE DECISION MADE: 22-NOV-13
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADHESIVE ELECTRODES
TOP-RANK HEALTH CARE EQUIPMENT CO.510(k) NO: K132588(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 22815850
P.O. BOX 120-119 SE DECISION MADE: 22-NOV-13
SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFIA DISTAL ACCESS CATHETER
MICRO VENTION, INC. 510(k) NO: K131482(TRADITIONAL)
ATTN: NAOMI GONG PHONE NO : 714 247 8000
1311 VALENCIA AVENUE SE DECISION MADE: 22-NOV-13
TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V8 TRANSLUMINAL BAV CATHETER
INTERVALVE, INC 510(k) NO: K132728(SPECIAL)
ATTN: SEW-WAH TAY PHONE NO : 612 801 6782
84801 73RD AVENUE NORTH, SUITE 63 SE DECISION MADE: 22-NOV-13
MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SP-FIX SPINOUS PROCESS FIXATION PLATE
GLOBE MEDICAL, INC. 510(k) NO: K132191(TRADITIONAL)
ATTN: CHRISTINA KICHULA PHONE NO : 610 930 1800
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 22-NOV-13
AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS CK-MB CALCHECK 5
ROCHE DIAGNOSTICS 510(k) NO: K133284(TRADITIONAL)
ATTN: KELLI TURNER PHONE NO : 317 521 4515
9115 HAGUE ROAD SE DECISION MADE: 22-NOV-13
INDIANAPOLIS IN 46250 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRESCENT SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K133216(SPECIAL)
ATTN: ANKIT K SHAH PHONE NO : 800 876 3133
1800 PYRAMID PLACE SE DECISION MADE: 22-NOV-13
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-STICK VASCULAR ACCESS SET
ARGON MEDICAL 510(k) NO: K130730(SPECIAL)
ATTN: JENNIFER BONACCI PHONE NO : 352 519 5029
3600 SW 47TH AVE SE DECISION MADE: 22-NOV-13
GAINESVILLE FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSE-4BABY SYSTEM
SENSE4BABY, INC. 510(k) NO: K132918(TRADITIONAL)
ATTN: JACQUES GINESTET PHONE NO : 858 412 8605
3344 N. TORREY PINES COURT, STE 10SE DECISION MADE: 22-NOV-13
LA JOLLA CA 92037 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EASYCARE ONLINE
RESMED LTD. 510(k) NO: K132371(TRADITIONAL)
ATTN: JIM CASSI PHONE NO : 858 836 6081
9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 22-NOV-13
SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLARITY LPC LASER SYSTEM
LUTRONIC CORPORATION 510(k) NO: K130199(TRADITIONAL)
ATTN: JHUNG WON VOJIR PHONE NO : 215 205 2219
6 NESHAMINY INTERPLEX, SUITE 207 SE DECISION MADE: 22-NOV-13
TREVOSE PA 19053 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM PRISMA, MAGNETOM PRISMA FIT
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132119(TRADITIONAL)
ATTN: NADIA SOOKDEO PHONE NO : 610 448 4918
51 VALLEY STREAM PKWY. SE DECISION MADE: 22-NOV-13
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOPTOUCH /OTHER CLIENTS PRIVATE LABELING
JIANGSU TOPTOUCH GLOVE CO., LTD. 510(k) NO: K131826(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441
RM 1606 BLDG, 1 JIAN XIANG YUAN NOSE DECISION MADE: 22-NOV-13
BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
CARDIOVASCULAR SYSTEMS INCORPORATE510(k) NO: K133399(SPECIAL)
ATTN: BLAIR BUTH PHONE NO : 651 259 2032
651 CAMPUS DR. SE DECISION MADE: 22-NOV-13
SAINT PAUL MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DANA REUSABLE BI TEST PACK
DANA PRODUCTS, INC. 510(k) NO: K130135(TRADITIONAL)
ATTN: HARRY BALA PHONE NO : 847 455 2881
7 COREY DR. SE DECISION MADE: 25-NOV-13
SOUTH BARINGTON IL 60010 510(k) STATEMENT
DEVICE: CAPNOMASK
MEDIPLUS LTD. 510(k) NO: K131339(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
24301 WOODSAGE DRIVE SE DECISION MADE: 25-NOV-13
BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX COMPRESSION FT SCREWS
ARTHREX, INC. 510(k) NO: K132217(TRADITIONAL)
ATTN: COURTNEY SMITH PHONE NO : 239 643 5553
1370 CREEKSIDE BOULEVARD SE DECISION MADE: 25-NOV-13
NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACK COLOURED CONDOM
KAREX INDUSTRIES SDN BHD 510(k) NO: K132597(ABBREVIATED)
ATTN: MARY GOH YIN PHONE NO : 607 688 1800
PTD. 7906/7907, TAMAN PONTIAN JAYASE DECISION MADE: 25-NOV-13
PONTIAN, JOHOR MY 82000 510(k) STATEMENT
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K132639(TRADITIONAL)
ATTN: SHWETA SHARMA PHONE NO : 901 396 3133
1800 PYRAMID PLACE SE DECISION MADE: 25-NOV-13
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAULT-C INTERVERTEBRAL BODY FUSION DEVICE
EMPIRICAL TESTING CORPORATION 510(k) NO: K132029(TRADITIONAL)
ATTN: MEREDITH MAY PHONE NO : 719 264 9937
4628 NORTHPARK DRVE SE DECISION MADE: 25-NOV-13
COLORADO SPRINGS CO 80918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIA / VITALITY ANALYZER
IPGDX, LLC 510(k) NO: K130856(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720 962 5412
33 GOLDEN EAGLE LANE SE DECISION MADE: 25-NOV-13
LITTLETON CO 80127 510(k) STATEMENT
DEVICE: INBODY
BIOSPACE CORPORATION LIMITED 510(k) NO: K130777(TRADITIONAL)
ATTN: DANIEL KAMM, P.E. PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 25-NOV-13
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
ZIMMER SPINE, INC. 510(k) NO: K132884(TRADITIONAL)
ATTN: JONATHAN GILBERT PHONE NO : 952 830 6385
7375 BUSH LAKE RD. SE DECISION MADE: 25-NOV-13
MINNEAPOLIS MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANAX 5.5 SPINAL SYSTEM
U & I CORPORATION 510(k) NO: K132101(TRADITIONAL)
ATTN: YOUNG-GEUN KIM PHONE NO : 82 31 8520102
20, SANDAN-RO, 76BEON-GIL (RD) SE DECISION MADE: 25-NOV-13
UIJEONGBU-SI, GYEONGGI-DO KS 48510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM
CORELINK LLC 510(k) NO: K132504(TRADITIONAL)
ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800
1331 H STREET NW, 12TH FLOOR SE DECISION MADE: 25-NOV-13
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA
TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K132544(TRADITIONAL)
ATTN: CHRISTINE KLEIN PHONE NO : 49 893217 5830
EDISONSTRASSE 6 SE DECISION MADE: 25-NOV-13
UNTERSCHLEISSHEIM GM D-85716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FDR D-EVO FLAT PANEL DETECTOR SYSTEM
FUJIFILM MEDICAL SYSTEMS USA, INC.510(k) NO: K132509(TRADITIONAL)
ATTN: KATHERINE Y CHOI PHONE NO : 203 602 3568
419 WEST AVENUE SE DECISION MADE: 25-NOV-13
STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHARRUAPACS SYSTEM
CHARRUASOFT SA 510(k) NO: K133357(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 469 684 1980
111 MELANIE DRIVE SE DECISION MADE: 25-NOV-13
AUBREY TX 76227 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALVED TEARAWAY INTRODUCER GENERATION II
MEDCOMP (MEDICAL COMPONENTS, INC.)510(k) NO: K132498(SPECIAL)
ATTN: TIMOTHY HOLWICK PHONE NO : 215 256 4201
1499 DELP DR. SE DECISION MADE: 25-NOV-13
HARLEYSVILLE PA 19438 510(k) STATEMENT
DEVICE: NEURODYN MULTIWAVE, AUSSIE SPORT
IBRAMED EQUIPAMENTOS MEDICOS 510(k) NO: K131629(TRADITIONAL)
ATTN: LILIAN LLULL PHONE NO : 305 377 0077
18851 NE 29TH AVE 720 SE DECISION MADE: 26-NOV-13
AVENTURA FL 33180 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
EXACTECH, INC. 510(k) NO: K131298(TRADITIONAL)
ATTN: SHING JEN TAI, PHD PHONE NO : 352 377 1140
2320 N.W. 66TH CT. SE DECISION MADE: 26-NOV-13
GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR
SPS MEDICAL SUPPLY CORP. 510(k) NO: K122024(TRADITIONAL)
ATTN: GARY J SOCOLA PHONE NO : 585 359 0130
6789 W Henrietta Rd SE DECISION MADE: 26-NOV-13
Industry NY 14543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHASER V-MINI RX
SHASER, INC. 510(k) NO: K132170(TRADITIONAL)
ATTN: ANTHONY BURNS PHONE NO : 781 995 2246
10 MAGUIRE ROAD SE DECISION MADE: 26-NOV-13
LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLAX
DONGGUAN PRESTIGE SPORTING GOODS C510(k) NO: K131302(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 4 22465396
16F-2(16A), NO. 462, SEC. 2 CHONGDSE DECISION MADE: 26-NOV-13
TAICHUNG TW 406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC
PHILIPS MEDIZIN SYSTEME BOEBLINGEN510(k) NO: K131913(ABBREVIATED)
ATTN: MARKUS STACHA PHONE NO : 49 7031 4632840
HEWLETT-PACKARD STR. 2 SE DECISION MADE: 26-NOV-13
BOEBLINGEN, BW GM D-71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE INFUSION SET
SHANGHAI JINTA MEDICAL CO., LTD 510(k) NO: K131646(TRADITIONAL)
ATTN: WANG CHANGQING PHONE NO : 021 6736 1700
NO. 18, JIANDING ROAD SE DECISION MADE: 26-NOV-13
FENGJING TOWN, JINSHAN DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR
JIANGSU HANDSAFE GLOVE CO., LTD. 510(k) NO: K131828(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441
ROOM 1606 BLDG 1, JIAN XIANG YUAN SE DECISION MADE: 26-NOV-13
BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
JIANGSU HEALTHCARE PRODUCTS CO., L510(k) NO: K131831(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441
ROOM 1606 BLDG 1, JIAN XIANG YUAN SE DECISION MADE: 26-NOV-13
BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CV3000 HOLTER ANALYSIS SYSTEM
VALES & HILLS BIOMEDICAL TECH. LTD510(k) NO: K131897(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 22815850
P.O. BOX 120-119 SE DECISION MADE: 26-NOV-13
SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMOTION ECG MOBILE
MEGA ELECTRONICS LTD. 510(k) NO: K131699(TRADITIONAL)
ATTN: ANDRE KINDSVATER PHONE NO : 31 70 3458570
PRINSESSEGRACHT 20 SE DECISION MADE: 26-NOV-13
THE HAGUE NL 2514 AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)
TYRX , INC. 510(k) NO: K132699(TRADITIONAL)
ATTN: REGINA NOVAK PHONE NO : 732 964 1492
1 DEER PARK DR. SUITE G SE DECISION MADE: 26-NOV-13
MONMOUTH JUNCTION NJ 08852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERITEC GREEN CARD PACK BOWIE-DICK TEST
STERITEC PRODUCTS MFG. CO., INC. 510(k) NO: K132372(TRADITIONAL)
ATTN: JONATHAN RUTIGLIANO PHONE NO : 303 660 4201
74 INVERNESS DRIVE EAST SE DECISION MADE: 26-NOV-13
ENGLEWOOD CO 80112 510(k) STATEMENT
DEVICE: NEWTRON BOOSTER
SATELEC-ACTEON GROUP 510(k) NO: K131997(TRADITIONAL)
ATTN: RICK ROSATI PHONE NO : 800 289 6367
124 GAITHER DRIVE , SUITE 140 SE DECISION MADE: 26-NOV-13
MT LAUREL NJ 08054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM
SPINEFRONTIER, INC. 510(k) NO: K132740(TRADITIONAL)
ATTN: PAUL L SPEIDEL PHONE NO : 978 232 3990
500 CUMMINGS CENTER SUITE 3500 SE DECISION MADE: 26-NOV-13
BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIATHLON TRITANIUM METAL-BACKED PATELLA
STRYKER ORTHOPAEDICS 510(k) NO: K132624(TRADITIONAL)
ATTN: SHIKHA KHANDELWAL PHONE NO : 201 831 6921
325 CORPORATE DRIVE SE DECISION MADE: 26-NOV-13
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
ROCHE DIAGNOSTICS 510(k) NO: K133330(SPECIAL)
ATTN: SUSAN HOLLANDBECK PHONE NO : 317 521 3380
9115 SOUTH HAGUE ROAD SE DECISION MADE: 26-NOV-13
INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KNIT-PAK+
PREMIER DENTAL PRODUCTS CO. 510(k) NO: K132526(TRADITIONAL)
ATTN: VINCENT D’ALLESANDRO PHONE NO : 610 239 6000
1710 ROMANO DR. SE DECISION MADE: 26-NOV-13
PLYMOUTH MEETING PA 19462 510(k) STATEMENT
DEVICE: FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K131369(TRADITIONAL)
ATTN: LEIGH SPOTTEN PHONE NO : 424 218 8738
2151 E. GRAND AVENUE SE DECISION MADE: 26-NOV-13
EL SEGUNDO CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYBERWAND STERILE PROBE SET
CYBERSONICS, INC. 510(k) NO: K132795(SPECIAL)
ATTN: LORI COLVIN PHONE NO : 814 898 4734
5325 KUHL RD. SE DECISION MADE: 26-NOV-13
Erie PA 16510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASPIRE RX-LP6 ASPIRATION CATHETER
CONTROL MEDICAL TECHNOLOGY, LLC 510(k) NO: K131998(TRADITIONAL)
ATTN: SHAWN FOJTIK PHONE NO : 435 602 9640
136 HEBER AVENUE, SUITE 101 PO BOXSE DECISION MADE: 26-NOV-13
PARK CITY UT 84068 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GENESIS LED WANDS
GENESIS BIOSYSTEMS, INC. 510(k) NO: K131142(TRADITIONAL)
ATTN: JIM LAFFERTY PHONE NO : 972 315 7888
1500 EAGLE COURT SE DECISION MADE: 27-NOV-13
LEWISVILLE TX 75057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUSHA-M52C MEDICAL DISPLAY
NANJING JUSHA DISPLAY TECHNOLOGY C510(k) NO: K131390(TRADITIONAL)
ATTN: MIKE GU PHONE NO : 86 20 62321333
7TH FLOOR, 982. CONGYUN RD. BAIYUNSE DECISION MADE: 27-NOV-13
GUANGZHOU, GUANGDONG CH 510420 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHON ANTERIOR CERVICAL PLATE SYSTEM
NUVASIVE, INC. 510(k) NO: K131025(TRADITIONAL)
ATTN: CYNTHIA ADAMS PHONE NO : 858 320 4549
7475 LUSK BLVD SE DECISION MADE: 27-NOV-13
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROGS
MOLECULAR PRODUCTS LTD. 510(k) NO: K131016(SPECIAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
24301 WOODSAGE DR. SE DECISION MADE: 27-NOV-13
BONITA SPRINGS FL 34134 2958 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE
ADVANCED BRAIN MONITORING INC. 510(k) NO: K131383(TRADITIONAL)
ATTN: ADRIENNE LENZ PHONE NO : 262 290 0023
W324 S3649 COUNTY ROAD E SE DECISION MADE: 27-NOV-13
DOUSMAN WI 53118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)
PEGA MEDICAL INC. 510(k) NO: K131591(TRADITIONAL)
ATTN: ARIEL R DUJOVNE PHONE NO : 450 688514 4
1111 AUTOROUTE CHOMEDEY SE DECISION MADE: 27-NOV-13
LAVAL CA H7W 5J8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITLE 2 POLYAXIAL SPINAL SYSTEM
ZIMMER SPINE, INC. 510(k) NO: K133086(TRADITIONAL)
ATTN: MICHELLE LENZ PHONE NO : 952 830 6243
7375 BUSH LAKE RD. SE DECISION MADE: 27-NOV-13
MINNEAPOLIS MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESPIN SYSTEM
NLT SPINE LTD 510(k) NO: K133061(TRADITIONAL)
ATTN: JOHN J SMITH PHONE NO : 202 637 3638
555 13TH ST NW SE DECISION MADE: 27-NOV-13
WASHINGTON DC 20004 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
REVERSE MEDICAL CORPORATION 510(k) NO: K133282(SPECIAL)
ATTN: JEFFREY VALKO PHONE NO : 949 215 0660
13700 Alton Parkway Suite 167 SE DECISION MADE: 27-NOV-13
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYLABSEVEN, MYLABALPHA
ESAOTE, S.P.A. 510(k) NO: K132231(TRADITIONAL)
ATTN: ALLISON SCOTT PHONE NO : 317 569 9500
9001 WESLEYAN ROAD SUITE 200 SE DECISION MADE: 27-NOV-13
INDIANAPOLIS IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE COLOR
ZIBO INTCO MEDICAL PRODUCTS CO., L510(k) NO: K132201(TRADITIONAL)
ATTN: JOHN ZHAO PHONE NO : 909 548 4828
12390 EAST END AVE. SE DECISION MADE: 27-NOV-13
CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-CUBE 7
ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K132687(TRADITIONAL)
ATTN: DONGHWAN KIM PHONE NO : 82 70 74652068
1, 6 AND 7FL, VERDI TOWER 72, DIGISE DECISION MADE: 27-NOV-13
SEOUL KS 152-848 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIP MIS INTERSPINOUS FUSION SYSTEM
AURORA SPINE 510(k) NO: K133091(TRADITIONAL)
ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800
331 H STREET NW, 12TH FL. SE DECISION MADE: 27-NOV-13
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM
SAMSUNG MEDISON CO., LTD 510(k) NO: K133329(TRADITIONAL)
ATTN: PARK KYEONG-MI PHONE NO :
42, TEHERAN-RO 108-GIL GANGNAM-GU SE DECISION MADE: 27-NOV-13
SEOUL KS 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS
TELEFLEX MEDICAL 510(k) NO: K132658(TRADITIONAL)
ATTN: ASHLEA RICCI, RAC PHONE NO : 919 433 8065
2917 WECK DR. SE DECISION MADE: 27-NOV-13
RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECULAR MICROSCOPE CEM-530
NIDEK CO., LTD. 510(k) NO: K130565(TRADITIONAL)
ATTN: ARON SHAPIRO PHONE NO : 978 685 8900
300 BRICKSTONE SQUARE SE DECISION MADE: 27-NOV-13
ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIEZOSURGERY FLEX
MECTRON S.P.A. 510(k) NO: K132848(TRADITIONAL)
ATTN: ROGER GRAY PHONE NO : 39 06 5782665
PIAZZA ALBANIA 10 SE DECISION MADE: 29-NOV-13
ROME IT 00153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INOMAX DSIR (DELIVERY SYSTEM)
INO THERAPEUTICS/IKARIA 510(k) NO: K131686(TRADITIONAL)
ATTN: ROBERT BOVY PHONE NO : 608 226 3450
2902 DAIRY DRIVE SE DECISION MADE: 29-NOV-13
MADISON WI 53718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LESSRAY
SAFERAY SPINE, LLC 510(k) NO: K132970(SPECIAL)
ATTN: CALLEY HERZOG PHONE NO : 720 883 3633
400 N. WASHINGTON ST., STE 100 SE DECISION MADE: 29-NOV-13
ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANQUILL BARBED DEVICE
SURGICAL SPECIALTIES CORP. DBA ANG510(k) NO: K133420(SPECIAL)
ATTN: KIRSTEN STOWELL PHONE NO : 610 404 3367
100 DENNIS DR. SE DECISION MADE: 29-NOV-13
Reading PA 19606 510(k) SUMMARY AVAILABLE FROM FDA
