TOTAL 510(k)s THIS PERIOD 247
TOTAL WITH SUMMARIES 231
TOTAL WITH STATEMENTS 16
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD February 2014
DEVICE: LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K131653(TRADITIONAL)
ATTN: BERNICE LIN PHONE NO : 408 732 3856
670 ALMANOR AVENUE SE DECISION MADE: 04-FEB-14
SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA FLASH CENTROMERE
INOVA DIAGNOSTICS, INC. 510(k) NO: K123880(TRADITIONAL)
ATTN: ANDREA SEAMAN PHONE NO : 858 586 9900
9900 OLD GROVE RD. SE DECISION MADE: 07-FEB-14
SAN DIEGO CA 92131 1638 510(k) STATEMENT
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)
BECTON, DICKINSON AND COMPANY 510(k) NO: K132909(TRADITIONAL)
ATTN: KATIE COYLE PHONE NO : 410 316 4975
7 LOVETON CIRCLE MC 614 SE DECISION MADE: 14-FEB-14
SPARKS MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO
BIOTEST MEDICAL CORP. 510(k) NO: K133509(SPECIAL)
ATTN: ROBERT NAWY PHONE NO : 732 389 8112
1 INDUSTRIAL WAY WEST/ BUILDING E,SE DECISION MADE: 21-FEB-14
EATONTOWN NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
PHADIA AB 510(k) NO: K133404(SPECIAL)
ATTN: MARTIN R MANN PHONE NO : 269 492 1957
4169 COMMERCIAL AVE. SE DECISION MADE: 24-FEB-14
PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WONDFO MULTI-DRUG URINE TEST CUP, PANEL
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K133968(SPECIAL)
ATTN: JOE SHIA PHONE NO : 240 505 7880
504 EAST DIAMOND AVE. SUITE F SE DECISION MADE: 25-FEB-14
GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STATUS DS OXY
PRINCETON BIOMEDITECH CORP. 510(k) NO: K130650(TRADITIONAL)
ATTN: KYUNG-AH KIM PHONE NO : 732 274 1000
4242 U.S. HIGHWAY 1 SE DECISION MADE: 26-FEB-14
MONMOUTH JUNCTION NJ 08852 1905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM
THERMO FISHER SCIENTIFIC 510(k) NO: K133773(TRADITIONAL)
ATTN: CYNTHIA KNAPP PHONE NO : 800 871 8909
1 THERMO FISHER WAY SE DECISION MADE: 27-FEB-14
OAKWOOD VILLAGE OH 44146 510(k) STATEMENT
DEVICE: EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM
EPS BIO TECHNOLOGY CORP. 510(k) NO: K133647(SPECIAL)
ATTN: CYNTHIA HUNG PHONE NO : 886 3 6686868
NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 27-FEB-14
HSINCHU CITY, TW 30077 510(k) STATEMENT
DEVICE: HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
ABBOTT LABORATORIES 510(k) NO: K130255(TRADITIONAL)
ATTN: JUDITH R WALLACH PHONE NO : 847 937 1132
100 ABBOTT PARK RD. SE DECISION MADE: 28-FEB-14
ABBOTT PARK IL 60064 3502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
GOLD STANDARD DIAGNOSTICS 510(k) NO: K131334(TRADITIONAL)
ATTN: NAPLEON MONCE PHONE NO : 530 759 8000
2851 SPAFFORD ST SE DECISION MADE: 28-FEB-14
Davis CA 95618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
ROCHE DIAGNOSTICS 510(k) NO: K131605(TRADITIONAL)
ATTN: JANE PHILLIPS, PHD PHONE NO : 317 521 3338
9115 HAGUE ROAD P.O. BOX 50416 SE DECISION MADE: 28-FEB-14
INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
CERAGEM MEDISYS INC. 510(k) NO: K131727(TRADITIONAL)
ATTN: HAKSUNG KIM PHONE NO : 82 41 5298422
SE DECISION MADE: 28-FEB-14
CHEONAN SI, CHUNGCHEONGNAM-DO K510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IFA 40: HEP-20-10
EUROIMMUN US 510(k) NO: K131791(TRADITIONAL)
ATTN: MICHAEL LOCKE PHONE NO : 973 656 1000
1100 THE AMERICAN ROAD SE DECISION MADE: 26-FEB-14
MORRIS PLAINS NJ 07950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHOOCIN INTRODUCER KIT
LEPU MEDICAL TECHNOLOGY (BEIJING) 510(k) NO: K123475(TRADITIONAL)
ATTN: ARTHUR GODDARD PHONE NO : 216 233 5722
1531 FELTON ROAD SE DECISION MADE: 03-FEB-14
SOUTH EUCLID OH 44121 2722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEROYAL SPINE SPACER SYSTEM
DEROYAL INDUSTRIES, INC. 510(k) NO: K131292(TRADITIONAL)
ATTN: KAREN E WARDEN, PHD PHONE NO : 440 729 8457
PO BOX 566 SE DECISION MADE: 03-FEB-14
CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
I-FLOW LLC 510(k) NO: K131249(TRADITIONAL)
ATTN: SHELLY HARRIS PHONE NO : 949 206 2707
43 Discovery Suite 100 SE DECISION MADE: 03-FEB-14
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLINE SHARPS CONTAINER
MEDLINE INDUSTRIES, INC. 510(k) NO: K132767(TRADITIONAL)
ATTN: TIMUR SELIMKHANOV PHONE NO : 847 643 4736
ONE MEDLINE PLACE SE DECISION MADE: 03-FEB-14
MUNDELEIN IL 60060 510(k) STATEMENT
DEVICE: SARNS HIGH FLOW AORTIC ARCH CANNULA
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K133151(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800 262 3304
125 BLUE BALL RD. SE DECISION MADE: 03-FEB-14
ELKTON MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JULIET LL LATERAL LUMBAR CAGE
SPINEART 510(k) NO: K133557(TRADITIONAL)
ATTN: FRANCK PENNESI PHONE NO : 41 22 7994025
COINTRIN 20 ROUTE DE PRE-BOIS CP18SE DECISION MADE: 03-FEB-14
GENEVA SZ 1215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW
COVIDIEN 510(k) NO: K130320(TRADITIONAL)
ATTN: ELIZABETH MALO PHONE NO : 303 305 2763
6135 GUNBARREL AVE. SE DECISION MADE: 04-FEB-14
BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
HEZE CITY GREEN FOOD CO., LTD. 510(k) NO: K130582(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441
RM 1606 BLDG, 1 JIAN XIANG YUAN NOSE DECISION MADE: 04-FEB-14
BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STREAMLINE EXPRESS
NXSTAGE MEDICAL, INC. 510(k) NO: K132602(TRADITIONAL)
ATTN: MARY LOU STROUMBOS PHONE NO : 978 687 4872
350 MERRIMACK STREET SE DECISION MADE: 04-FEB-14
LAWRENCE MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER
DUTECK INDUSTRIAL CO., LTD. 510(k) NO: K132140(TRADITIONAL)
ATTN: JOSEPH CHEN PHONE NO : 886 2 87975035
3F-2, NO. 26, 513 LANE JUI-KUANG RSE DECISION MADE: 04-FEB-14
TAIPEI TW 114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K132886(TRADITIONAL)
ATTN: DAVID HENLEY PHONE NO : 901 399 6487
1450 BROOKS RD. SE DECISION MADE: 04-FEB-14
MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYRUS ACMI NEPHRO – EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER
GYRUS ACMI, INC. 510(k) NO: K132383(TRADITIONAL)
ATTN: NEIL KELLY PHONE NO : 508 804 2600
136 TURNPIKE RD. SE DECISION MADE: 04-FEB-14
SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K133794(TRADITIONAL)
ATTN: TATYANA KORSUNSKY PHONE NO : 508 828 3122
325 PARAMOUNT DR. SE DECISION MADE: 04-FEB-14
RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER(R) PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSION
ZIMMER, INC. 510(k) NO: K133737(TRADITIONAL)
ATTN: PAULINE A SHAND PHONE NO : 574 372 4765
P.O. BOX 708 SE DECISION MADE: 04-FEB-14
WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GFS II STANDARD, GFS II LARGE, GFS MIMI
PARCUS MEDICAL, LLC 510(k) NO: K133757(SPECIAL)
ATTN: PAUL VAGTS PHONE NO : 941 755 7965
6423 PARKLAND DRIVE SE DECISION MADE: 04-FEB-14
SARASOTA FL 34243 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONILASE LIGHT THERAPY DEVICE
BIORENEW LABS, LLC 510(k) NO: K132613(TRADITIONAL)
ATTN: SUSAN ANTHONEY PHONE NO : 865 329 6882
2424 DEMPSTER DRIVE SE DECISION MADE: 05-FEB-14
CORALVILLE IA 52241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RT016 INSPIRATORY FILTER
FISHER & PAYKEL HEALTHCARE LTD. 510(k) NO: K133666(TRADITIONAL)
ATTN: ELIZABETH GOLDSTEIN PHONE NO : 649 574 0100
15 MAURICE PAYKEL PLACE, EAST TAMASE DECISION MADE: 05-FEB-14
AUCKLAND NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER
CARDIOSOLUTIONS INC 510(k) NO: K140015(SPECIAL)
ATTN: CHRISTINE SANTAGATE PHONE NO : 781 344 0801
375 WEST STREET SE DECISION MADE: 05-FEB-14
WEST BRIGEWATER MA 02379 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT
MAINE STANDARDS COMPANY LLC 510(k) NO: K133550(TRADITIONAL)
ATTN: JAMES W CHAMPLIN PHONE NO : 207 892 1300
221 US ROUTE 1 SE DECISION MADE: 05-FEB-14
CUMBERLAND FORESIDE ME 04110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K133601(TRADITIONAL)
ATTN: PHILIP LIU PHONE NO : 914 524 2443
511 BENEDICT AVE. SE DECISION MADE: 05-FEB-14
TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)
TERUMO EUROPE N.V. 510(k) NO: K133867(SPECIAL)
ATTN: M.J. AERTS PHONE NO : 321 638 1211
INTERLEUVENLAAN 40 SE DECISION MADE: 05-FEB-14
LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
AIR PLASTIC CO., LTD. 510(k) NO: K130890(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 108238 7441
ROOM 1606 BLDG. 1 JIANXIANG YUAN NSE DECISION MADE: 06-FEB-14
BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALIVECOR HEART MONITOR OTC
ALIVECOR, INC. 510(k) NO: K130921(TRADITIONAL)
ATTN: MICHAEL RIGHTER PHONE NO : 415 795 9812
30 MAIDEN LANE, 6TH FLOOR SE DECISION MADE: 06-FEB-14
SAN FRANCISCO CA 94108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-MAX+ (PLUS)
AAT ALBER ANTRIEBSTECHNIK GMBH 510(k) NO: K130864(TRADITIONAL)
ATTN: STEFANIE D BANKSTON PHONE NO : 409 229 0022
2611 SHARK CIRCLE SE DECISION MADE: 06-FEB-14
TEXAS CITY TX 77591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRITY SPINAL CARE SYSTEM 3.0
INTEGRITY LIFE SCIENCES 510(k) NO: K130249(TRADITIONAL)
ATTN: JAMES J GIBSON PHONE NO : 813 933 5500
2189 WEST BUSCH BLVD SE DECISION MADE: 06-FEB-14
TAMPA FL 33612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG WINFUL PLASTIC CO., L510(k) NO: K131341(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441
ROOM 1606 BLDG 1, JIANXIANG YUAN NSE DECISION MADE: 06-FEB-14
BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION
CARESTREAM HEALTH,INC. 510(k) NO: K132824(TRADITIONAL)
ATTN: DAVID C FURR PHONE NO : 512 906 9654
8708 CAPEHART COVE SE DECISION MADE: 06-FEB-14
AUSTIN TX 78733 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUAL ENERGY SYSTEM PACKAGE
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K132813(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714 669 7808
2441 MICHELLE DRIVE SE DECISION MADE: 06-FEB-14
TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUSE 1C COLONOSCOPY SYSTEM
ENDOCHOICE, INC. 510(k) NO: K132839(TRADITIONAL)
ATTN: DANIEL HOEFER PHONE NO : 678 708 4743
11810 WILLS ROAD SE DECISION MADE: 06-FEB-14
ALPHARETTA GA 30009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAPIX SUPERELASTIC IMPLANT BONE STAPLES
INSTRATEK, INC. 510(k) NO: K133523(TRADITIONAL)
ATTN: JEFF SEAVEY PHONE NO : 281 890 8020
15200 Middlebrook Dr Ste G SE DECISION MADE: 06-FEB-14
Houston TX 77058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APTUS HELI-FX GUIDE – 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE – 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH
APTUS ENDOSYSTEMS, INC. 510(k) NO: K140036(SPECIAL)
ATTN: BURT GOODSON PHONE NO : 408 530 9050
271 GIBRALTAR DRIVE SE DECISION MADE: 06-FEB-14
SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VDRIVE WITH V-SONO
STEREOTAXIS, INC. 510(k) NO: K133396(SPECIAL)
ATTN: DIANE HORWITZ, PH.D. RAC PHONE NO : 703 307 2921
4320 FOREST PARK AVENUE SUITE 100 SE DECISION MADE: 06-FEB-14
ST. LOUIS MO 63108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVANT MCT SYSTEM
CORVENTIS, INC. 510(k) NO: K133701(SPECIAL)
ATTN: CHERYL SWANSON PHONE NO : 651 762 1824
1410 ENERGY PARK DRIVE, SUITE 1 SE DECISION MADE: 06-FEB-14
ST. PAUL MN 55108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRSTRIP REMOTE PATIENT MONITORING
AIRSTRIP TECHNOLOGIES, LP 510(k) NO: K133394(TRADITIONAL)
ATTN: ROBERT A MILLER PHONE NO :
335 E. SONTERRA BLVD. SUITE 200 SE DECISION MADE: 06-FEB-14
SAN ANTONIO TX 78258 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL
FAMIDOC TECHNOLOGY CO., LTD 510(k) NO: K130723(TRADITIONAL)
ATTN: REANNY WANG PHONE NO : 86 769892 724888674
No.212 Yilong Road, Hexi IndustriaSE DECISION MADE: 07-FEB-14
Dongguan CN 523853 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALERTWATCH: OR
ALERTWATCH LLC 510(k) NO: K130401(TRADITIONAL)
ATTN: DONNA-BEA TILLMAN PHONE NO : 410 531 6542
6594 AUTUMN WIND CIRCLE SE DECISION MADE: 07-FEB-14
CLARKSVILLE MD 21029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
HOPE PLASTIC CO., LTD. 510(k) NO: K130807(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO :
ROOM 1606 BLDG. 1 JIANXIANG YUAN NSE DECISION MADE: 07-FEB-14
BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES
BIOPSYBELL S.R.L. 510(k) NO: K130616(TRADITIONAL)
ATTN: WILLER GHELFI PHONE NO : 973 519 0431
62 GERDES AVE. SE DECISION MADE: 07-FEB-14
VERONA NJ 07004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NB3D BONE VOID FILLER
PIONEER SURGICAL TECHNOLOGY, INC 510(k) NO: K132050(TRADITIONAL)
ATTN: EMILY DOWNS PHONE NO : 906 225 5602
375 RIVER PARK CIRCLE SE DECISION MADE: 07-FEB-14
Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM
TWIN STAR MEDICAL, INC. 510(k) NO: K131966(SPECIAL)
ATTN: GREGORY W SACHS PHONE NO : 612 840 1568
5116 BIRCH RD. SE DECISION MADE: 07-FEB-14
MINNETONKA MN 55345 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RING-LOK MODULAR BIPOLAR SYSTEM
IMPLANTS INTERNATIONAL, LTD 510(k) NO: K132539(TRADITIONAL)
ATTN: TRUDIE SEEGAR, PHD PHONE NO : 614 876 6374
4170 BOWMANSROOT COURT SE DECISION MADE: 07-FEB-14
HILLIARD OH 43026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)
PROTEUS DIGITAL HEALTH, INC. 510(k) NO: K133263(SPECIAL)
ATTN: JAFAR SHENASA PHONE NO : 650 637 6109
2600 BRIDGE PARKWAY, SUITE 101 SE DECISION MADE: 07-FEB-14
REDWOOD CITY CA 94065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECLIPSE TREATMENT PLANNING SYSTEM
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K133247(TRADITIONAL)
ATTN: PETER J CORONADO PHONE NO : 650 424 6320
911 HANSEN WAY SE DECISION MADE: 07-FEB-14
PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM
HUNTLEIGH HEALTHCARE LIMITED 510(k) NO: K132650(TRADITIONAL)
ATTN: LAURA GARCIA DEACON PHONE NO : 442 92 0447703
35 PORTMANMOOR ROAD SE DECISION MADE: 07-FEB-14
CARDIFF, WALES UK CF24 5HN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUOCENTRIC REVERSED SHOULDER PROSTHESIS
ASTON MEDICAL 510(k) NO: K133462(TRADITIONAL)
ATTN: CATHERINE GLOSTER PHONE NO : 805 679 1258
577 NORTH HOPE AVE SE DECISION MADE: 07-FEB-14
SANTA BARBARA CA 93110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT
HANSEN MEDICAL 510(k) NO: K133552(SPECIAL)
ATTN: HASSAN LABAY PHONE NO : 650 404 5888
800 EAST MIDDLEFIELD ROAD SE DECISION MADE: 07-FEB-14
MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTASSIST AND VENASSIST
ACI MEDICAL, LLC 510(k) NO: K131146(TRADITIONAL)
ATTN: ED ARKANS PHONE NO : 760 744 4400
1857 DIAMOND ST SE DECISION MADE: 10-FEB-14
SAN MARCOS CA 92078 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CITRISOL ACID CONCENTRATE
DIASOL, INC. 510(k) NO: K130511(TRADITIONAL)
ATTN: MONICA ABELES PHONE NO : 818 838 7077
1110 Arroyo St SE DECISION MADE: 10-FEB-14
San Fernando CA 91340 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXXZR(TM)T AND NEXXZR(TM)S
SAGEMAX BIOCERAMICS, INC. 510(k) NO: K130991(TRADITIONAL)
ATTN: JOSE E CABRERA PHONE NO : 561 339 2815
34210 9th Ave S Suite 118 SE DECISION MADE: 10-FEB-14
Federal Way WA 98003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070
INTERVENTIONAL SPINE, INC. 510(k) NO: K133583(SPECIAL)
ATTN: JANE METCALF PHONE NO : 949 472 0006
13700 ALTON PKWY., SUITE 160 SE DECISION MADE: 10-FEB-14
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMRI 1.5T AND IMRI 3T S
IMRIS, INC. 510(k) NO: K133692(TRADITIONAL)
ATTN: SANJAY SHAH PHONE NO : 763 203 6380
5101 Shady Oak Rd SE DECISION MADE: 10-FEB-14
Minnetonka MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TOEGRIP, IMPLANT FOR PROXIMAL INTER-PHALANGEAL ARTHRODESIS
SYNCHRO MEDICAL 510(k) NO: K133477(TRADITIONAL)
ATTN: MARK F SCHENK PHONE NO : 610 507 8255
505 BERKS PLACE SE DECISION MADE: 10-FEB-14
WEST LAWN PA 19609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUILION ONE VISION
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K133497(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714 669 7808
2441 MICHELLE DRIVE SE DECISION MADE: 10-FEB-14
TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-PLUS
PIONEER SURGICAL TECHNOLOGY, INC 510(k) NO: K133623(TRADITIONAL)
ATTN: SARAH MCINTYRE PHONE NO : 906 225 5861
375 RIVER PARK CIRCLE SE DECISION MADE: 10-FEB-14
Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EQUINOXE EXTRA SHORT HUMERAL HEAD
EXACTECH, INC. 510(k) NO: K140063(SPECIAL)
ATTN: PATRICK HUGHES PHONE NO : 352 327 4762
2320 N.W. 66TH CT. SE DECISION MADE: 11-FEB-14
GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD
JUSTRIGHT SURGICAL, LLC 510(k) NO: K132472(TRADITIONAL)
ATTN: MICHELE LUCEY PHONE NO : 603 748 1374
128 BLYE HILL LANDING SE DECISION MADE: 11-FEB-14
NEWBURY NH 03255 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-IO INTRAOSSEOUS INFUSION SYSTEM
VIDACARE CORPORATION 510(k) NO: K132583(TRADITIONAL)
ATTN: LARRY J MILLER PHONE NO : 210 375 8500
4350 LOCKHILL SELMA ROAD SE DECISION MADE: 11-FEB-14
SHAVANO PARK TX 78249 2095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK
KAPSTONE MEDICAL, LLC 510(k) NO: K132925(TRADITIONAL)
ATTN: JOHN KAPITAN PHONE NO : 704 843 7852
100 E. SOUTH MAIN ST. SE DECISION MADE: 11-FEB-14
WAXHAW NC 28173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTROL SEAL
VOCO GMBH 510(k) NO: K130485(TRADITIONAL)
ATTN: T. GERKENSMEIER PHONE NO : 49 4721 719200
ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 11-FEB-14
CUXHAVEN GM D-27472 510(k) STATEMENT
DEVICE: GUAVA II
CARDIOCOMM SOLUTIONS, INC. 510(k) NO: K122632(TRADITIONAL)
ATTN: JONATHAN WARD PHONE NO : 813 645 2855
445 APOLLO BEACH BLVD. SE DECISION MADE: 11-FEB-14
APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DANA REUSABLE TEST PACK
DANA PRODUCTS, INC. 510(k) NO: K133267(TRADITIONAL)
ATTN: HARRY BALA PHONE NO : 847 455 2881
7 COREY DR. SE DECISION MADE: 11-FEB-14
SOUTH BARRINGTON IL 60010 510(k) STATEMENT
DEVICE: ADHESE UNIVERSAL
IVOCLAR VIVADENT AG 510(k) NO: K133318(TRADITIONAL)
ATTN: DONNA HARTNETT PHONE NO : 716 691 2260
175 PINEVIEW DR. SE DECISION MADE: 11-FEB-14
AMHERST NY 14228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY
ORTHOCON, INC. 510(k) NO: K140117(SPECIAL)
ATTN: HOWARD L SCHRAYER PHONE NO : 609 924 9510
1 BRIDGE STREET, SUITE 121 SE DECISION MADE: 11-FEB-14
IRVINGTON NY 10533 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDORINGS
ENDO-AID, INC. 510(k) NO: K133359(TRADITIONAL)
ATTN: JANICE M HOGAN PHONE NO : 267 675 4611
1835 MARKET STREET, 29TH FLOOR SE DECISION MADE: 11-FEB-14
PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V8 TRANSLUMINAL BAV CATHETER
INTERVALVE, INC 510(k) NO: K133607(TRADITIONAL)
ATTN: JULIE BODMER PHONE NO : 612 910 3412
8401 73RD AVENUE NORTH, STE 63 SE DECISION MADE: 11-FEB-14
MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEPITEL AG
MOLNLYCKE HEALTH CARE 510(k) NO: K130040(TRADITIONAL)
ATTN: ANGELA L BUNN PHONE NO : 678 250 7930
5550 PEACHTREE PARKWAY SUITE 500 SE DECISION MADE: 12-FEB-14
NORCROSS GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES
QUBE MEDICAL PRODUCT SDN BHD 510(k) NO: K123537(TRADITIONAL)
ATTN: TERENCE LIM PHONE NO : 603 6034 4710
NO 10, JALAN KPK 1/1, KAWASAN PERISE DECISION MADE: 12-FEB-14
KUNDANG MY 48020 510(k) STATEMENT
DEVICE: ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET;
ZEVEX, INC. 510(k) NO: K131154(SPECIAL)
ATTN: NILOUFAR SAMIMI PHONE NO : 801 264 1001
4314 ZEVEX PARK LN. SE DECISION MADE: 12-FEB-14
Salt Lake City UT 84123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
DECENT PLASTIC CO., LTD. 510(k) NO: K131033(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO :
ROOM 1606 BLG 1 JIANXIANG YUAN NO SE DECISION MADE: 12-FEB-14
BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OWL CONTACT LENS CASES, DOG CONTACT LENS CASES
NINGBO LISHUNDA ELECTRONICS CO., L510(k) NO: K130930(TRADITIONAL)
ATTN: CHARLES SHEN PHONE NO : 608 217 9358
5 CAREY STREET SE DECISION MADE: 12-FEB-14
PENNINGTON NJ 08534 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERHEART G5 AED
CARDIAC SCIENCE CORPORATION 510(k) NO: K122758(TRADITIONAL)
ATTN: KATHLEEN ROBERTS PHONE NO : 949 797 3844
N7 W22025 Johnson Dr — SE DECISION MADE: 12-FEB-14
Waukesha WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-BOX PEEK CERVICAL IBF
INNOVASIS, INC. 510(k) NO: K132991(TRADITIONAL)
ATTN: MARSHALL MCCARTY PHONE NO : 801 261 2236
614 EAST 3900 SOUTH SE DECISION MADE: 12-FEB-14
SALT LAKE CITY UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PTFE SURGICAL SUTURE
OMNIA SPA 510(k) NO: K132464(TRADITIONAL)
ATTN: MARCO MANDUCHI PHONE NO : 390 54 2643496
VIA SARAGAT 5 SE DECISION MADE: 12-FEB-14
IMOLA, BO IT 40026 510(k) STATEMENT
DEVICE: EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM
EXACTECH, INC. 510(k) NO: K132582(TRADITIONAL)
ATTN: PATRICK HUGHES PHONE NO : 352 327 4762
2320 N.W. 66TH CT. SE DECISION MADE: 12-FEB-14
GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD
TOTAL JOINT ORTHOPEDICS, INC. 510(k) NO: K131454(TRADITIONAL)
ATTN: JEAN M WHEELER PHONE NO : 801 486 6070
1567 E. Stratford Avenue SE DECISION MADE: 12-FEB-14
Salt Lake City UT 84106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHASER V-MINI 2 HAIR REMOVAL SYSTEM
SHASER, INC. 510(k) NO: K133201(TRADITIONAL)
ATTN: ANTHONY BURNS PHONE NO : 781 995 2246
10 MAGUIRE RD BUILDING ONE SE DECISION MADE: 12-FEB-14
LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METRIXCARE
THE METRIX COMPANY 510(k) NO: K132424(TRADITIONAL)
ATTN: NICHOLAS SPECHT PHONE NO : 563 556 8800
4400 CHAVENELLE RD. SE DECISION MADE: 12-FEB-14
DUBUQUE IA 52002 2655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENA PRO
INNOVAMED HEALTH, LLC 510(k) NO: K133274(TRADITIONAL)
ATTN: JOE ADKINS PHONE NO : 216 849 7847
2839 HARVEST MOON DRIVE SE DECISION MADE: 12-FEB-14
ORANGE PARK FL 32073 32073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONVENTUS DRS
CONVENTUS ORTHOPAEDICS 510(k) NO: K131552(TRADITIONAL)
ATTN: KENT LIND PHONE NO : 763 515 5000
10200 73RD AVENUE NORTH STE 122 SE DECISION MADE: 12-FEB-14
MAPLE GROVE MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K132720(TRADITIONAL)
ATTN: ALINA STUBBS PHONE NO : 610 651 5000
65 GREAT VALLEY PAKRWAY SE DECISION MADE: 12-FEB-14
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 15 FR. TANDEMHEART ARTERIAL CANNULA
CARDIACASSIST INC. 510(k) NO: K133293(SPECIAL)
ATTN: GREG JOHNSON PHONE NO : 412 963 7770
240 ALPHA DRIVE SE DECISION MADE: 12-FEB-14
PITTSBURGH PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEODESICEEG SYSTEM 400 SERIES (GES 400)
ELECTRICAL GEODESICS, INC. 510(k) NO: K131882(TRADITIONAL)
ATTN: LINDA J BOVARD PHONE NO : 541 345 5431
29611 SIMMONS ROAD SE DECISION MADE: 12-FEB-14
EUGENE OR 97405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGER MEDICAL ESU-110
LIGER MEDICAL, LLC 510(k) NO: K133273(TRADITIONAL)
ATTN: STEVE SMITH PHONE NO : 801 532 0221
825 N 300 WEST #NE127 SE DECISION MADE: 12-FEB-14
SALT LAKE CITY UT 84103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPERSOUND AUDIO SYSTEM (HSS)
HYPERSOUND HEALTH, INC. 510(k) NO: K133352(TRADITIONAL)
ATTN: JAMES A BARNES PHONE NO : 888 496 8001
13771 DANIELSON ST. STE. L SE DECISION MADE: 12-FEB-14
POWAY CA 92064 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHYSIOFLOW Q-LINK
VASOCOM, INC. 510(k) NO: K140102(SPECIAL)
ATTN: JAMES GUNNERSON PHONE NO : 215 826 9998
2014 FORD RD., UNIT G SE DECISION MADE: 12-FEB-14
BRISTOL PA 19007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESTORELLE Y CONTOUR MESH
COLOPLAST A/S 510(k) NO: K140116(SPECIAL)
ATTN: TIM CRABTREE PHONE NO : 612 302 4922
1601 WEST RIVER ROAD N SE DECISION MADE: 12-FEB-14
MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION
CARL ZEISS MEDITEC AG 510(k) NO: K133476(TRADITIONAL)
ATTN: SARAH HARRINGTON PHONE NO : 925 560 5134
5160 HACIENDA DRIVE SE DECISION MADE: 12-FEB-14
DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MDIXON-QUANT
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K133526(TRADITIONAL)
ATTN: SUSAN QUICK PHONE NO : 440 483 2291
595 MINER RD. SE DECISION MADE: 12-FEB-14
CLEVLAND OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOGIQ E
GE HEALTHCARE 510(k) NO: K133533(TRADITIONAL)
ATTN: BRYAN BEHN PHONE NO : 414 721 4214
9900 INNOVATION DRIVE SE DECISION MADE: 12-FEB-14
WAUWATOSA WI 53233 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRODUCER SETS, MODEL ADELANTE RADIAL
OSCOR INC. 510(k) NO: K130633(TRADITIONAL)
ATTN: MILA DOSKOCIL PHONE NO : 727 937 2511
3816 DE SOTO BLVD. SE DECISION MADE: 13-FEB-14
PALM HARBOR FL 34683 510(k) STATEMENT
DEVICE: MANUAL WHEELCHAIR
ZHEJIANG JIAFENG ELECTRICAL & MECH510(k) NO: K132257(TRADITIONAL)
ATTN: CHARLES SHEN PHONE NO : 608 217 9358
5 CAREY STREET SE DECISION MADE: 13-FEB-14
PENNINGTON NJ 08534 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALS PLATINUM NEUROSTIMULATION ELECTRODES
AXELGAARD MFG. CO., LTD. 510(k) NO: K132422(TRADITIONAL)
ATTN: DAN P JEFFERY PHONE NO : 760 451 8000
520 INDUSTRIAL WAY SE DECISION MADE: 13-FEB-14
FALLBROOK CA 92028 2244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVAPATCH ET IONTOPHORESIS PATCH
ACTIVATEK INC. 510(k) NO: K132832(TRADITIONAL)
ATTN: JAMAL YANAKI PHONE NO : 800 680 5520
2734 S. 3600 WEST UNIT F SE DECISION MADE: 13-FEB-14
WEST VALLEY CITY UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARRICADE EMBOLIZATION COIL SYSTEM
BLOCKADE MEDICAL 510(k) NO: K140104(SPECIAL)
ATTN: REBECCA K PINE PHONE NO : 760 809 5178
18 Technology Dr Ste 169 SE DECISION MADE: 13-FEB-14
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TREZ_HD
EXCEL-TECH LTD. (XLTEK) 510(k) NO: K131266(TRADITIONAL)
ATTN: DANIEL RAMIREZ PHONE NO : 905 829 5300
2568 BRISTOL CIR. SE DECISION MADE: 14-FEB-14
OAKVILLE, ONTARIO CA L6H 5S1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR
BRACCO DIAGNOSTIC, INC. 510(k) NO: K132192(TRADITIONAL)
ATTN: TRACEY ALEXANDER PHONE NO : 609 524 2865
259 PROSPECT PLAINS ROAD BUILDING SE DECISION MADE: 14-FEB-14
MONROE TOWNSHIP NJ 08831 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERPORT IMPLANTABLE PORT
C.R. BARD, INC. 510(k) NO: K133335(TRADITIONAL)
ATTN: AMY HONEY PHONE NO : 801 522 5671
605 N 5600 W SE DECISION MADE: 14-FEB-14
SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTAL BONE SCREWS; DENTAL BONE SCREWS, CONTINUING; SCREW SYSTEM TX; SCREW SYSTEM TX PROFESSIONAL
HAGER & MEISINGER GMBH 510(k) NO: K132212(TRADITIONAL)
ATTN: WIEBKE STOLTEN PHONE NO : 49 213120 12388
HANSEMANNSTRASSE 10 SE DECISION MADE: 14-FEB-14
NEUSS GM D-41468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STELLARIS VISION ENHANCEMENT SYSTEM
BAUSCH & LOMB 510(k) NO: K133242(SPECIAL)
ATTN: TIMOTHY W CAPEHART PHONE NO : 636 226 3017
3365 TREE COURT INDUSTRIAL BLV SE DECISION MADE: 14-FEB-14
ST LOUIS MO 63122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS
SYLPHAR N.V. 510(k) NO: K132426(TRADITIONAL)
ATTN: ROGER GRAY PHONE NO : 39 06 5782665
PIAZZA ALBANIA 10 SE DECISION MADE: 14-FEB-14
ROME, ITALY IT 00153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVEAL LINQ INSERTABLE CARDIAC MONITOR
MEDTRONIC INC. 510(k) NO: K132649(TRADITIONAL)
ATTN: ERIC KALMES PHONE NO : 763 526 2809
8200 CORAL SEA STREET NE SE DECISION MADE: 14-FEB-14
MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XCATH
ALSEAL 510(k) NO: K133296(TRADITIONAL)
ATTN: YOLANDA SMITH PHONE NO : 888 729 9674
1468 HARWELL AVENUE SE DECISION MADE: 14-FEB-14
CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VICTUS FEMTOSECOND LASER PLATFORM
TECHNOLAS PERFECT VISION GMBH 510(k) NO: K132534(TRADITIONAL)
ATTN: KEN NEHMER PHONE NO : 415 297 0408
1025 SANCHEZ STREET SE DECISION MADE: 14-FEB-14
SAN FRANCISCO CA 94114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOJET ULTRA AVX THROMBECTOMY SET
POSSIS MEDICAL, INC. 510(k) NO: K133629(SPECIAL)
ATTN: GEORGE LUCAS PHONE NO : 763 780 4555
9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 14-FEB-14
MINNEAPOLIS MN 55433 8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3MP GRAYSCAKE LCD DISPLAY
SHENZHEN BEACON DISPLAY TECHNOLOGY510(k) NO: K140103(TRADITIONAL)
ATTN: WU QIN PHONE NO : 867 552699 5355
RM 201, INCUBATOR BUILDING, CASTD,SE DECISION MADE: 14-FEB-14
SHENZHEN, GUANGDONG CH 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3MP COLOR LCD DISPLAY
SHENZHEN BEACON DISPLAY TECHNOLOGY510(k) NO: K140108(TRADITIONAL)
ATTN: WU QIN PHONE NO : 86 755269 95355
RM 201, INCUBATOR BUILDING, CASTD,SE DECISION MADE: 14-FEB-14
SHENZHEN, GUANGDONG CH 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: L.A.M. IPM WOUND GEL, IPM DERM GEL
GLYCOBIOSCIENCES, INC 510(k) NO: K130781(TRADITIONAL)
ATTN: OLUFEMI ADEOYE PHONE NO : 905 271 2709 X 225
181 LAKESHORE ROAD EAST SE DECISION MADE: 14-FEB-14
MISSISSAUGA, ONTARIO CA L5G 1G2510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE
CELLCO PARTNERSHIP D/B/A VERIZON W510(k) NO: K134004(TRADITIONAL)
ATTN: LOLITA D FORBES PHONE NO : 202 515 2454
ONE VERIZON WAY SE DECISION MADE: 14-FEB-14
BASKING RIDGE NJ 07920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE
NIPRO MEDICAL CORPORATION 510(k) NO: K140136(SPECIAL)
ATTN: JESSICA OSWALD-MCLEOD PHONE NO : 305 599 7174
3150 N.W. 107TH AVE. SE DECISION MADE: 14-FEB-14
DORAL FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MD302C4 29.8" DIAGNOSTIC IMAGING LCD MONITOR
NEC DISPLAY SOLUTIONS, LTD. 510(k) NO: K133708(TRADITIONAL)
ATTN: TONY HSU PHONE NO : 886 22603 7288
1F, NO. 181, SEC. 2 WUNHUA 1ST ROASE DECISION MADE: 14-FEB-14
NEW TAIPEI CITY TW 24457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRSTRIP REMOTE PATIENT MONITORING
AIRSTRIP TECHNOLOGIES, LP 510(k) NO: K133450(SPECIAL)
ATTN: ROBERT A MILLER PHONE NO : 210 363 8753
335 E. SONTERRA BLVD. SUITE 200 SE DECISION MADE: 14-FEB-14
SAN ANTONIO TX 78258 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES
FRIEND PLASTIC CO., LTD. 510(k) NO: K130891(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO :
ROOM 1606 BLDG. 1 JIANXIANG YUAN NSE DECISION MADE: 18-FEB-14
BEIJING CH 050000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
JEWEL PLASTIC CO., LTD. 510(k) NO: K130809(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441
ROOM 1606 BLDG. 1 JIANXIANG YUAN NSE DECISION MADE: 18-FEB-14
BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
KAIXUAN PLASTIC CO., LTD. 510(k) NO: K130800(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 108238 7441
RM.1606 BLDG.1 JIANXIANG YUAN NO.2SE DECISION MADE: 18-FEB-14
HAIDIAN DISTRICT, BEIJING CH 10510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A SERIES AND Q SERIES PATIENT MONITORS
GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K131898(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 22815850
P.O. BOX 120-119 SE DECISION MADE: 18-FEB-14
SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SARNS SOFT-FLOW AORTIC CANNULA
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K132451(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800 262 3304
125 BLUE BALL RD. SE DECISION MADE: 18-FEB-14
ELKTON MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDOS HILITE OXYGENATOR
MEDOS MEDIZINTECHNIK AG 510(k) NO: K140177(SPECIAL)
ATTN: LEANN CHRISTMAN PHONE NO : 734 995 9089
3526 WEST LIBERTY RD. SE DECISION MADE: 18-FEB-14
ANN ARBOR MI 48103 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIDISHEILD
TIDI PRODUCTS, LLC 510(k) NO: K132953(TRADITIONAL)
ATTN: DION BRANDT PHONE NO : 920 751 4386
570 ENTERPRISE DR. SE DECISION MADE: 18-FEB-14
NEENAH WI 54956 510(k) STATEMENT
DEVICE: KASM KNEE ARTICULATING SPACER MOLDS
ORTHO DEVELOPMENT CORP. 510(k) NO: K133449(TRADITIONAL)
ATTN: MIKE ENSIGN PHONE NO : 801 553 9991
12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 18-FEB-14
DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDICINAL LEECHES
BIOPHARM (UK) LTD. 510(k) NO: K132958(TRADITIONAL)
ATTN: BETHANY SAWYER PHONE NO : 44 1792 885595
2 BRYNGWILI ROAD SE DECISION MADE: 19-FEB-14
HENDY UK SA4 0XT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RS-3000 ADVANCE
NIDEK CO., LTD. 510(k) NO: K132323(TRADITIONAL)
ATTN: LENA SATTLER PHONE NO : 440 554 3706
1667 RIDGEWOOD RD SE DECISION MADE: 19-FEB-14
WADSWORTH OH 44281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE
CARDICA, INC. 510(k) NO: K140170(SPECIAL)
ATTN: VEE ARYA PHONE NO : 650 644 7339
900 SAGINAW DR. SE DECISION MADE: 19-FEB-14
REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDOS HILITE INFANT OXYGENATOR
MEDOS MEDIZINTECHNIK AG 510(k) NO: K140181(SPECIAL)
ATTN: LEANN CHRISTMAN PHONE NO : 734 995 9089
3526 WEST LIBERTY RD. SE DECISION MADE: 19-FEB-14
ANN ARBOR MI 48103 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO NAUTILUS SPINAL SYSTEM
LIFE SPINE, LLC. 510(k) NO: K133564(SPECIAL)
ATTN: RANDY LEWIS PHONE NO : 847 884 6117
2401 W. HASSELL RD. SUITE 1535 SE DECISION MADE: 19-FEB-14
HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K140030(TRADITIONAL)
ATTN: TAN ZHIFENG PHONE NO : 86 75581 885334
BLDG. 9-13 BAIWANGXIN HIGH-TEC INDSE DECISION MADE: 19-FEB-14
SHENZHEN, NAHSHAN CH 518108 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 30.0 INCH COLOR LCD MONITOR CCL650I2 (CL30650, MD302C6)
JVC KENWOOD CORPORATION 510(k) NO: K140214(TRADITIONAL)
ATTN: TSUKASA TASHIRO PHONE NO : 81 258 246611
3-12 MORIYA-CHO, KANAGAWA-KU SE DECISION MADE: 19-FEB-14
YOKOHAMA-SHI, KANAGAWA JA 221-0510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 8MM TROCAR KIT
INTUITIVE SURGICAL 510(k) NO: K133845(TRADITIONAL)
ATTN: BRANDON HANSEN PHONE NO : 408 523 7485
1266 KIFER ROAD SE DECISION MADE: 19-FEB-14
SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFANT PHOTOTHERAPY BILITRON SKY 5006
FANEM LDA 510(k) NO: K131196(TRADITIONAL)
ATTN: TARA CONRAD PHONE NO : 305 377 0077
18851 NE 29TH AVE 720 SE DECISION MADE: 20-FEB-14
AVENTURA FL 33180 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANCED PERFUSION SYSTEM 1
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K131041(TRADITIONAL)
ATTN: MARK BUR PHONE NO : 734 663 4145
6200 JACKSON RD. SE DECISION MADE: 20-FEB-14
ANN ARBOR MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JMS SYRINGE
JMS NORTH AMERICA CORPORATION 510(k) NO: K132321(TRADITIONAL)
ATTN: SHO HOSOKI PHONE NO : 510 888 9090
22320 FOOTHILL BLVD SUITE 350 SE DECISION MADE: 20-FEB-14
HAYWARD CA 94541 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
NEOMETRICS, INC. 510(k) NO: K133076(TRADITIONAL)
ATTN: DAVID LIEBL PHONE NO : 763 559 4440
2605 FERNBROOK LANE N. SUITE J SE DECISION MADE: 20-FEB-14
PLYMOUTH MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIEVA SCOUT SINUS DILATION SYSTEM
ACCLARENT, INC. 510(k) NO: K140160(SPECIAL)
ATTN: JAMES P GARVEY, II PHONE NO : 650 687 4807
1525-B O’BRIEN DR. SE DECISION MADE: 20-FEB-14
MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROINSERT
NIDACON INTERNATIONAL AB 510(k) NO: K131145(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 20-FEB-14
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
GLOBUS MEDICAL INC. 510(k) NO: K133567(SPECIAL)
ATTN: CHRISTINA KICHULA PHONE NO : 610 930 1800
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 20-FEB-14
AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JAZZ SYSTEM
IMPLANET S.A. 510(k) NO: K133617(TRADITIONAL)
ATTN: JANICE M HOGAN PHONE NO : 267 675 4611
1835 MARKET ST. 29TH FLOOR SE DECISION MADE: 20-FEB-14
PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INBONE TOTAL ANKLE
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K133585(SPECIAL)
ATTN: VAL MYLES PHONE NO : 901 290 5162
5677 AIRLINE RD. SE DECISION MADE: 20-FEB-14
ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PELLEFIRM
ELLMAN INTERNATIONAL, INC. 510(k) NO: K132949(TRADITIONAL)
ATTN: ALISON SATHE PHONE NO : 516 594 3333
400 KARIN LANE SE DECISION MADE: 20-FEB-14
HICKSVILLE NY 11801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANTATA(R) 2.9 MICROCATHETER
COOK, INC. 510(k) NO: K131772(TRADITIONAL)
ATTN: JENNIFER A RICHARDSON PHONE NO : 812 339 2235
750 DANIELS WAY SE DECISION MADE: 20-FEB-14
BLOOMINGTON IN 47402 0489 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIOM REG
ANTHOGYR SAS 510(k) NO: K131066(TRADITIONAL)
ATTN: THERESE CANDAU PHONE NO : 330 450580 237
2237, AVENUE ANDRE LASQUIN SE DECISION MADE: 21-FEB-14
SALLANCHES FR 74700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLINE BIOPSY VALVE
MEDLINE INDUSTRIES, INC. 510(k) NO: K131426(TRADITIONAL)
ATTN: MATT CLAUSEN PHONE NO : 847 643 4785
ONE MEDLINE PLACE SE DECISION MADE: 21-FEB-14
MUNDELEIN IL 60060 510(k) STATEMENT
DEVICE: LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM
NUCLETRON B.V. 510(k) NO: K132874(SPECIAL)
ATTN: RUDOLF VOS PHONE NO : 31 318 557133
WAARDGELDER 1 SE DECISION MADE: 21-FEB-14
VEENENDAAL NL 3905 TH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN,
STRAUMANN USA, LLC 510(k) NO: K132219(TRADITIONAL)
ATTN: JENNIFER M JACKSON PHONE NO : 978 747 2509
60 MINUTEMAN ROAD SE DECISION MADE: 21-FEB-14
ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEME
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K132935(TRADITIONAL)
ATTN: CHRISTINE DUNBAR PHONE NO : 925 293 5442
757 A ARNOLD DRIVE SE DECISION MADE: 21-FEB-14
MARTINEZ CA 94553 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNI PATENT MONITORS
INFINIUM MEDICAL 510(k) NO: K132229(TRADITIONAL)
ATTN: JOHN O’BRIEN PHONE NO : 813 645 2855
445 APOLLO BEACH BLVD SE DECISION MADE: 21-FEB-14
APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM
NONIN MEDICAL, INC. 510(k) NO: K132402(TRADITIONAL)
ATTN: BRODIE PEDERSEN PHONE NO : 763 577 3180
13700 1ST AVE. NORTH SE DECISION MADE: 21-FEB-14
PLYMOUTH MN 55441 5443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER
BIOCARE ASIA CORPORATION LTD. 510(k) NO: K132457(TRADITIONAL)
ATTN: SHUCHI CHANG PHONE NO : 86 512 68097762
NO. 260, MAYUN ROAD SE DECISION MADE: 21-FEB-14
NEW DISTRICT SUZHOU CH 215129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLAATZ 600 SERIES (FLAATZ 600/601)
DRTECH CORP. 510(k) NO: K132842(SPECIAL)
ATTN: CHOUL-WOO SHIN PHONE NO : 82 31 7848856
333-1, SANGDAEWON1-DONG JUNGWON-GUSE DECISION MADE: 21-FEB-14
SEONGNAM-SHI, GYEONGGI-DO KS 46510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREEDOM PCK COMPONENTS
MAXX ORTHOPEDICS, INC. 510(k) NO: K131481(TRADITIONAL)
ATTN: NACH DAVE PHONE NO : 732 718 1385
531 PLYMOUTH RD., SUITE 526 SE DECISION MADE: 21-FEB-14
PLYMOUTH MEETING PA 19462 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-TYPE D-KAT, R-TYPE D-KAT
KEELER LIMITED 510(k) NO: K133234(TRADITIONAL)
ATTN: EUGENE R VANARSDALE PHONE NO : 610 353 4350
456 PARKWAY SE DECISION MADE: 21-FEB-14
BROOMALL PA 19008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXYGEN GENERATOR LIQUEFIER – (OGL)
ESSEX CRYOGENICS OF MISSOURI, INC.510(k) NO: K131990(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
8007 CHIVVIS DR. SE DECISION MADE: 21-FEB-14
ST. LOUIS MO 63123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM
JEDMED INSTRUMENT CO. 510(k) NO: K132039(TRADITIONAL)
ATTN: CRAIG PARKS PHONE NO : 314 845 3770
5416 JEDMED CT. SE DECISION MADE: 21-FEB-14
ST. LOUIS MO 63129 2221 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLAROID CONTACTSPOD
VIOPTI LTD 510(k) NO: K131783(TRADITIONAL)
ATTN: EDWIN LINDSAY PHONE NO : 004 40791 7134922
POLAROID BLDG, VALE OF LEVEN INDUSSE DECISION MADE: 21-FEB-14
DUMBARTON UK G82 3PW 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVOHIP TOTAL HIP SYSTEM
NOVOSOURCE INC 510(k) NO: K132158(TRADITIONAL)
ATTN: SHARON KVISTAD PHONE NO : 317 228 8715
714 E. MONUMENT AVE. STE 219 SE DECISION MADE: 21-FEB-14
DAYTON OH 45402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONITOR B40
GE MEDICAL SYSTEMS CHINA CO., LTD.510(k) NO: K133576(SPECIAL)
ATTN: ROBERT CASARSA PHONE NO : 414 362 3063
8200 WEST TOWER AVE SE DECISION MADE: 21-FEB-14
MILWAUKEE WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT
BARD PERIPHERAL VASCULAR, INC. 510(k) NO: K133948(SPECIAL)
ATTN: SARAH MCCARTNEY PHONE NO : 480 638 2954
1625 WEST 3RD ST. SE DECISION MADE: 21-FEB-14
TEMPE AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA CENTAUR TESTOSTERONE (TSTO)
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K133491(TRADITIONAL)
ATTN: MATTHEW GEE PHONE NO : 914 524 2099
511 BENEDICT AVENUE SE DECISION MADE: 21-FEB-14
TARRYTOWN NY 10591 5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA
RAYENCE CO., LTD 510(k) NO: K133409(SPECIAL)
ATTN: DAVE KIM PHONE NO : 713 467 2607
8310 BUFFALO SPEEDWAY SE DECISION MADE: 21-FEB-14
HOUSTON TX 77025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHERPA PAK CARDIAC TRANSPORT SYSTEM
PARAGONIX TECHNOLOGIES, INC. 510(k) NO: K133432(TRADITIONAL)
ATTN: LEO BASTA PHONE NO : 617 834 9866
93 BENEFIT STREET SE DECISION MADE: 21-FEB-14
PROVIDENCE RI 02904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K133710(TRADITIONAL)
ATTN: BERNICE LIN PHONE NO : 408 732 3856
670 Almanor Ave SE DECISION MADE: 21-FEB-14
SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM
COVIDIEN 510(k) NO: K131252(TRADITIONAL)
ATTN: MICHAEL AYMAMI PHONE NO : 303 305 2481
6135 GUNBARREL AVE. SE DECISION MADE: 24-FEB-14
BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MATRICEL DENTAL BARRIER MEMBRANE
MATRICEL GMBH 510(k) NO: K123697(TRADITIONAL)
ATTN: DR. INGO HESCHEL PHONE NO : 492 407564 411
KAISERSTRABE 100 SE DECISION MADE: 24-FEB-14
HERZOGENRATH GM 52134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DALTON LIFT CHAIR
DALTON INSTRUMENT CORP. 510(k) NO: K131909(TRADITIONAL)
ATTN: MEI LEIN PHONE NO : 469 522 1200
16300 Addison Rd Ste 120 SE DECISION MADE: 24-FEB-14
Addison TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIR-FLOW HANDY 3.0 PERIO
E.M.S. ELECTRO MEDICAL SYSTEMS S.A510(k) NO: K132480(TRADITIONAL)
ATTN: CYNTHIA J NOLTE PHONE NO : 919 859 4207
62 FOREST ST., STE 300 SE DECISION MADE: 24-FEB-14
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEODENT IMPLANT SYSTEM
JJ INDUSTRIA E COMERCIO DE MATERIA510(k) NO: K133510(TRADITIONAL)
ATTN: KEVIN A THOMAS PHONE NO : 858 792 1235
11264 EL CAMINO REAL, SUITE 400 SE DECISION MADE: 24-FEB-14
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &
CODMAN & SHURTLEFF, INC. 510(k) NO: K133625(SPECIAL)
ATTN: HANNAH FOLEY PHONE NO : 305 265 6810
325 PARAMOUNT DR. SE DECISION MADE: 24-FEB-14
RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTRIMILOCK ANKLE PLATING SYSTEM
OSTEOMED LP 510(k) NO: K133691(TRADITIONAL)
ATTN: BLESSON ABRAHAM PHONE NO : 972 677 4600
3885 Arapaho Rd SE DECISION MADE: 24-FEB-14
ADDISON TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER
WELL LEAD MEDICAL CO. LTD 510(k) NO: K133615(TRADITIONAL)
ATTN: JOHN OBRIEN PHONE NO : 813 645 2855
445 APOLLO BEACH BLVD. SE DECISION MADE: 24-FEB-14
APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
CELONOVA BIOSCIENCES, INC. 510(k) NO: K133447(TRADITIONAL)
ATTN: NICOLE BARBER PHONE NO : 210 497 6682
18615 TUSCANY STONE SUITE 100 SE DECISION MADE: 24-FEB-14
SAN ANTONIO TX 78258 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETRACTION PASTE
DMG USA, INC. 510(k) NO: K130580(TRADITIONAL)
ATTN: PAMELA PAPINEAU, RAC PHONE NO : 978 772 3552
5 WHITCOMB AVE. SE DECISION MADE: 25-FEB-14
AYER MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ TRANSPORT CHAIR
HARRIS MEDICAL, LLC 510(k) NO: K130517(TRADITIONAL)
ATTN: JAMES WASON, PH.D. PHONE NO : 603 672 4678
7 VILLAGE WOODS DR SE DECISION MADE: 25-FEB-14
AMHERST NH 03031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED
DANIEL & DANIEL CONSULTING 510(k) NO: K132389(TRADITIONAL)
ATTN: MICHAEL A DANIEL PHONE NO : 415 407 0223
8 SNOWBERRY COURT SE DECISION MADE: 25-FEB-14
ORINDA CA 94563 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSULIN PEN NEEDLE
WENZHOU WUZHOU IMPORT & EXPORT CO.510(k) NO: K133058(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 22815850
P.O. BOX 120-119 SE DECISION MADE: 25-FEB-14
SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSULIN PEN NEEDLE
WENZHOU BEIPU SCIENCE & TECHNOLOGY510(k) NO: K133059(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 22815850
P.O. BOX 120-119 SE DECISION MADE: 25-FEB-14
SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UP600 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM
QISDA CORPORATION 510(k) NO: K132690(TRADITIONAL)
ATTN: BOB LEIKER PHONE NO : 925 556 1302
7263 CRONIN CIRCLE SE DECISION MADE: 25-FEB-14
DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMILEBOND SYSTEM
MILLENNIUM COMPANY LLC 510(k) NO: K132599(TRADITIONAL)
ATTN: STEPHEN J GOLDNER, JD, RAC PHONE NO : 248 712 0356
40701 WOODWARD AVE, STE 102 SE DECISION MADE: 25-FEB-14
BLOOMFIELD HILLS MI 48302 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-Z CHECK OZONE TEST STRIPS
REPROCESSING PRODUCTS CORPORATION 510(k) NO: K132344(TRADITIONAL)
ATTN: MICHAEL HONSTEIN PHONE NO : 520 888 5551
1643 W. MODERN COURT SE DECISION MADE: 25-FEB-14
TUCSON AZ 85705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CISNAP CLOSED INCISION SYSTEM
SPIRACUR, INC. 510(k) NO: K133137(TRADITIONAL)
ATTN: LORI E ADELS, PH.D. PHONE NO : 408 400 0856
755 N. MATHILDA AVENUE SUITE 100 SE DECISION MADE: 25-FEB-14
SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESSON SPINAL FIXATION SYSTEM
NEXUS SPINE, LLC 510(k) NO: K133287(TRADITIONAL)
ATTN: CHRIS HARMSTON PHONE NO : 801 742 8342
2825 EAST COTTONWOOD PKWY. SE DECISION MADE: 25-FEB-14
SALT LAKE CITY UT 84121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SFI-BAR IMPLANT ABUTMENTS
STERNGOLD DENTAL LLC 510(k) NO: K132814(ABBREVIATED)
ATTN: MARIA RAO PHONE NO : 508 226 5660
23 FRANK MOSSBERG DRIVE SE DECISION MADE: 25-FEB-14
ATTLEBORO MA 02703 0967 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED HD GUIDE CATHETER
CONCENTRIC MEDICAL, INC. 510(k) NO: K133177(TRADITIONAL)
ATTN: RHODA SANTOS PHONE NO : 510 413 2269
301 EAST EVELYN AVENUE SE DECISION MADE: 25-FEB-14
MOUNTAIN VIEW CA 94041 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SICAT FUNCTION
SICAT GMBH & CO. KG 510(k) NO: K133320(TRADITIONAL)
ATTN: MANFRED BREUER PHONE NO : 49 228 85469782
BRUNNENALLEE 6 SE DECISION MADE: 25-FEB-14
BONN GM D-53177 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SE-601 SERIES ELECTROCARDIOGRAPH
EDAN INSTRUMENTS, INC. 510(k) NO: K131503(TRADITIONAL)
ATTN: CHERRY SUN PHONE NO : 86 755268 56469
NANHAI ROAD 1019# NANSHEN SE DECISION MADE: 25-FEB-14
SHENZHEN, GUANGDONG CH 518067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA
MATERIALISE N.V. 510(k) NO: K133162(TRADITIONAL)
ATTN: OLIVER CLEMENS PHONE NO : 321 67 44537
TECHNOLOGIELAAN 15 SE DECISION MADE: 25-FEB-14
LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE
CARDICA, INC. 510(k) NO: K140118(SPECIAL)
ATTN: VEE ARYA PHONE NO : 650 644 7339
900 SAGINAW DR. SE DECISION MADE: 25-FEB-14
REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM GROWTH ROD SET
MEDTRONIC SOFAMOR DANEK USA 510(k) NO: K133904(TRADITIONAL)
ATTN: LEE GRANT PHONE NO : 901 396 3133
1800 PYRAMID PLACE SE DECISION MADE: 25-FEB-14
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO.VIA MI WORKFLOWS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K133644(TRADITIONAL)
ATTN: ALAINE MEDIO, RAC PHONE NO : 865 218 2703
810 INNOVATION DR. SE DECISION MADE: 25-FEB-14
KNOXVILLE TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEADLINER CS LEAD DELIVERY SYSTEM
VASCULAR SOLUTIONS, INC. 510(k) NO: K133501(TRADITIONAL)
ATTN: MIA HUNT PHONE NO : 763 656 4300
6464 SYCAMORE COURT NORTH SE DECISION MADE: 25-FEB-14
MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEODENT IMPLANT SYSTEM
JJGC INDUSTRIA E COMERCIO DE MATER510(k) NO: K133696(TRADITIONAL)
ATTN: KEVIN A THOMAS PHONE NO : 858 792 1235
11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 25-FEB-14
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTONEMV
INCONTROL MEDICAL, LLC 510(k) NO: K134020(TRADITIONAL)
ATTN: JESSICA ANDRESHAK PHONE NO : 262 373 0422
3225 GATEWAY ROAD, SUITE 250 SE DECISION MADE: 25-FEB-14
BROOKFIELD WI 53045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRINIAS
SHIMADZU CORP. 510(k) NO: K123508(ABBREVIATED)
ATTN: YOSHIHIRO MUKUTA PHONE NO : 075 823 1305
1,NISHINOKYO-KUWABARACHO, NAKAGYOKSE DECISION MADE: 26-FEB-14
KYOTO CITY JA 604-8511 510(k) STATEMENT
DEVICE: U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL
U&U MEDICAL TECHNOLOGY CO., LTD 510(k) NO: K123162(TRADITIONAL)
ATTN: GARFIELD WANG PHONE NO : 861 356 4751751
DONGZHOU VILLAGE, HENGSHANQIAO SE DECISION MADE: 26-FEB-14
CHANGZHOU CH 213119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSI Q SYSTEM ARTHROSCOPES
ORTHOPEDIC SCIENCES, INC 510(k) NO: K133018(TRADITIONAL)
ATTN: KEVIN A THOMAS PHONE NO : 858 792 1235
12264 EI CAMINO REAL SUITE 400 SE DECISION MADE: 26-FEB-14
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESSURE CONNECTING TUBE
SHENZHEN ANT HI-TECH INDUSTRIAL CO510(k) NO: K131770(TRADITIONAL)
ATTN: LYNN FU PHONE NO : 86 755 26903311
46 Keji Ave.,Yuquan Industrial ParSE DECISION MADE: 26-FEB-14
Dongguan CN 523696 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANAL RECTAL OVERTUBE
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K131598(TRADITIONAL)
ATTN: ERIC MAYNARD PHONE NO : 440 639 4494
5976 HEISLEY RD. SE DECISION MADE: 26-FEB-14
MENTOR OH 44060 510(k) STATEMENT
DEVICE: EXCELERON BACTERIAL FILTERS
EXCELERON MEDICAL 510(k) NO: K131626(TRADITIONAL)
ATTN: BERNARD HORWATH PHONE NO : 651 231 1761
4486 TIMBERLINE CT SE DECISION MADE: 26-FEB-14
VADNAIS HEIGHTS MN 55127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROSURFACE TOEMOTION
ARTHROSURFACE, INC. 510(k) NO: K132496(TRADITIONAL)
ATTN: DAWN J WILSON PHONE NO : 508 520 3003
28 FORGE PARKWAY SE DECISION MADE: 26-FEB-14
FRANKLIN MA 02038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)
NUCLETRON B.V. 510(k) NO: K132889(TRADITIONAL)
ATTN: RUDOLF VOS PHONE NO : 31 318 557133
WAARDGELDER 1 SE DECISION MADE: 26-FEB-14
VEENENDAAL NL 3905 TH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUREFIRE GUIDING CATHETER
SUREFIRE MEDICAL, INC. 510(k) NO: K140034(TRADITIONAL)
ATTN: LYNNE ARONSON PHONE NO : 720 305 9877
8601 TURNPIKE DR. STE 206 SE DECISION MADE: 26-FEB-14
WESTMINSTER CO 80031 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ST SENSE NV 8 ARRAY COIL
RESONANCE INNOVATIONS LLC 510(k) NO: K140282(SPECIAL)
ATTN: RANDALL JONES PHONE NO : 402 934 2650
9840 S 140th St Ste 8 SE DECISION MADE: 26-FEB-14
OMAHA NE 68138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE
BRONCUS MEDICAL INC 510(k) NO: K133385(TRADITIONAL)
ATTN: ROBIN BUSH PHONE NO : 650 428 1600
1400 N. Shoreline Blvd., Bldg A, SSE DECISION MADE: 26-FEB-14
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMERGE MEDICAL BONE PLATE SYSTEM
EMERGE MEDICAL 510(k) NO: K133536(TRADITIONAL)
ATTN: MICHELLE POTVIN PHONE NO : 720 459 6392
720 S. COLORADO BLVD. SUITE 550-S SE DECISION MADE: 26-FEB-14
DENVER CO 80246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEMUS 2 SYSTEM
EB NEURO, S.P.A. 510(k) NO: K133517(TRADITIONAL)
ATTN: ALLISON SCOTT, RAC PHONE NO : 317 569 9500
9001 WESLEYAN RD, STE 200 SE DECISION MADE: 26-FEB-14
INDIANAPOLIS IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MADSEN ACCUSCREEN TYPE 1077
GN OTOMETRICS 510(k) NO: K132957(TRADITIONAL)
ATTN: DANIEL KAMM, P.E. PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 27-FEB-14
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK
ABBOTT MEDICAL OPTICS INC 510(k) NO: K133115(ABBREVIATED)
ATTN: ROSANNE YETEMIAN PHONE NO : 714 247 8282
1700 E. ST. ANDREW PLACE SE DECISION MADE: 27-FEB-14
SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M SERIES PATIENT MONITOR
MID-LINK CONSULTING CO., LTD 510(k) NO: K131876(SPECIAL)
ATTN: DIANA HONG PHONE NO : 862 12 2815850
P.O. BOX 120-119 SE DECISION MADE: 27-FEB-14
SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SARNS SOFT-FLOW EXTENDED AORTIC CANNULA
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K132811(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800 262 3304
6200 JACKSON RD. SE DECISION MADE: 27-FEB-14
ANN ARBOR MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U&U STERILE PISTON SYRINGE WITHOUT NEEDLE
U&U MEDICAL TECHNOLOGY CO., LTD 510(k) NO: K132553(TRADITIONAL)
ATTN: XUEBO WANG PHONE NO : 008 6135 64751751
DONGZHOU VILLAGE, HENGSHANQIAO TOWSE DECISION MADE: 27-FEB-14
CHANGZHOU, JIANGSU CH 213119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TARGET3D FUSION
CONVERGENT LIFE SCIENCES, INC. 510(k) NO: K140033(TRADITIONAL)
ATTN: DINESH KUMAR PHONE NO : 916 526 2775
2377 GOLD MEADOW WAY SUITE 160 SE DECISION MADE: 27-FEB-14
GOLD RIVER CA 95670 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
ELLIPSE TECHNOLOGIES, INC. 510(k) NO: K140178(TRADITIONAL)
ATTN: JOHN MCINTYRE PHONE NO : 949 837 3600
13900 ALTON PARKWAY SUITE 123 SE DECISION MADE: 27-FEB-14
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX IBALANCE TKA SYSTEM
ARTHREX, INC. 510(k) NO: K133854(SPECIAL)
ATTN: LEON BROWN, II PHONE NO : 239 643 5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 27-FEB-14
NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JINTRONIX REHABILITATION SYSTEM (JRS)
JINTRONIX INC. 510(k) NO: K130847(TRADITIONAL)
ATTN: NAVNEET SEKHON PHONE NO : 905 854605 9
336 BRONTE ST SOUTH SUITE 224-225 SE DECISION MADE: 28-FEB-14
MILTON, ONTARIO CA L9T 7W6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE BITE GUARD
INTERNATIONAL PROFIT BUILDERS, INC510(k) NO: K132469(ABBREVIATED)
ATTN: BRYAN TAPOCIK PHONE NO : 909 864 7477
7045 PALM AVE SE DECISION MADE: 28-FEB-14
HIGHLAND CA 92346 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
ETHICON, INC. 510(k) NO: K132580(TRADITIONAL)
ATTN: PETER CECCHINI PHONE NO : 908 218 2457
ROUTE 22 WEST P.O. BOX 151 SE DECISION MADE: 28-FEB-14
SOMERVILLE NJ 08876 0151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLADIATOR ELITE PTA BALLOON DILATATION CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K132810(TRADITIONAL)
ATTN: BETH TOROK PHONE NO : 763 494 1273
ONE SCIMED PLACE SE DECISION MADE: 28-FEB-14
MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM
HYPER TECHNOLOGY INC 510(k) NO: K131777(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 22815850
P.O. BOX 120-119 SE DECISION MADE: 28-FEB-14
SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ND: YAG LASER SYSTEM
BEIJING TOPLASER TECHNOLOGY CO., L510(k) NO: K133158(TRADITIONAL)
ATTN: ZHANG XIAOSONG PHONE NO : 86 10 64354759
East 3rd Floor, Building M7, No.1 SE DECISION MADE: 28-FEB-14
Beijing CN 100015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LERADO, POWER WHEELCHAIR
LERADO GLOBAL (MACAO COMMERCIAL OF510(k) NO: K130982(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 852 524 75605
AVENIDA MARCIANO BAOTISTA, NO. 26-SE DECISION MADE: 28-FEB-14
Macau CH CH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANCED VIEWER
BRAINLAB, AG 510(k) NO: K132763(TRADITIONAL)
ATTN: ALEXANDER SCHWIERSCH PHONE NO : 4 989 9915680
KAPELLENSTR. 12 SE DECISION MADE: 28-FEB-14
FELDKIRCHEN GM 85622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES TROCHANTERIC FIXATION NAIL – ADVANCED SYSTEM
SYNTHES (USA) PRODUCTS, LLC 510(k) NO: K131548(TRADITIONAL)
ATTN: HEMAL MEHTA PHONE NO : 610 719 5424
1301 GOSHEN PKWY SE DECISION MADE: 28-FEB-14
WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMARC FIDUCIAL MARKER
CARBON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K132064(TRADITIONAL)
ATTN: ANDREW J ADAMS PHONE NO : 651 653 8512
1290 Hammond Rd SE DECISION MADE: 28-FEB-14
Saint Paul MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM
SUZHOU ANKE MEDICAL SYSTEM CO., LT510(k) NO: K131896(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 22815850
P.O. BOX 120-119 SE DECISION MADE: 28-FEB-14
SHANGHAI CH 200120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIXOS SCREW SYSTEM
STRYKER TRAUMA AG 510(k) NO: K133451(TRADITIONAL)
ATTN: ESTELA CELI PHONE NO : 201 831 6461
325 CORPORATE DR SE DECISION MADE: 28-FEB-14
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
CARDIOVASCULAR SYSTEMS, INC. 510(k) NO: K133999(SPECIAL)
ATTN: BLAIR BUTH PHONE NO : 651 259 2032
651 CAMPUS DRIVE SE DECISION MADE: 28-FEB-14
SAINT PAUL MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE DOME S6C
NDS SURGICAL IMAGING 510(k) NO: K133609(SPECIAL)
ATTN: JIM LENG PHONE NO : 408 776 0085
5750 HELLYER AVENUE SE DECISION MADE: 28-FEB-14
SAN JOSE CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXICARE FINGERTIP PULSE OXIMETER
DELBIO INCORPORATION 510(k) NO: K133090(SPECIAL)
ATTN: ERICA LI PHONE NO : 510 668 5141
4405 CUSHING PKWY. SE DECISION MADE: 28-FEB-14
FREMONT CITY CA 94538 510(k) STATEMENT
DEVICE: OSTEOMED EXTREMIFUSE SYSTEM
OSTEOMED 510(k) NO: K140283(SPECIAL)
ATTN: BLESSON ABRAHAM PHONE NO : 972 677 4795
3885 ARAPAHO ROAD SE DECISION MADE: 28-FEB-14
ADDISON TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICONIX ALL SUTURE ANCHORS
STRYKER CORP. 510(k) NO: K133671(TRADITIONAL)
ATTN: KELLY KUCHARCZYK PHONE NO : 303 336 7285
HOWMEDICA OSTEONICS SE DECISION MADE: 28-FEB-14
DENVER CO 80206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENSYN BAND
DALLEN MEDICAL, INC. 510(k) NO: K133858(TRADITIONAL)
ATTN: AL MEMMOLO PHONE NO : 949 218 0030
1046 Calle Recodo Ste G SE DECISION MADE: 28-FEB-14
San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESTO BREAST BIOPSY DEVICE
SONTINA MEDICAL, LLC 510(k) NO: K133702(SPECIAL)
ATTN: ROBERT PELIKS PHONE NO : 415 873 3831
111 SUTRO HEIGHTS AVENUE SE DECISION MADE: 28-FEB-14
SAN FRANCISCO CA 94121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHARLOTTE CLAW PLATE SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K133715(TRADITIONAL)
ATTN: LESLIE FITCH PHONE NO : 901 867 4120
5677 AIRLINE RD. SE DECISION MADE: 28-FEB-14
ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONODERM SURGICAL SUTURE
SURGICAL SPECIALTIES CORP. 510(k) NO: K140227(SPECIAL)
ATTN: KIRSTEN STOWELL FRANCO PHONE NO : 610 404 3367
100 DENNIS DR. SE DECISION MADE: 28-FEB-14
READING PA 19606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS
ARJOHUNTLEIGH POLSKA SP Z.O.O. 510(k) NO: K133119(TRADITIONAL)
ATTN: DAVID MOYNHAM PHONE NO : 44 2920 447084
35 PORTMANMOOR ROAD SE DECISION MADE: 28-FEB-14
CARDIFF, S. GLAMORGAN UK CF24 5510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NMI DIALYSIS CATHETER
NAVILYST MEDICAL, INC. 510(k) NO: K131260(TRADITIONAL)
ATTN: LORRAINE M HANLEY PHONE NO : 508 658 7945
26 FOREST STREET SE DECISION MADE: 14-FEB-14
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
