March 2012 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD March 2012
DEVICE: OASYS SURGICAL LIGHT CONTROLLER
OASYS HEALTHCARE 510(k) NO: K112133(TRADITIONAL)
ATTN: TANYA M O'BRIEN PHONE NO : 813 645 2855
962 ALLEGRO LANE SE DECISION MADE: 01-MAR-12
APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FD TENS 2070
FUJI DYNAMICS LTD 510(k) NO: K111654(TRADITIONAL)
ATTN: CHING KONG (FELIX) LEE PHONE NO : 852 27 864218
UNIT 1-3, 23/F LAWS COMMERICAL PLASE DECISION MADE: 01-MAR-12
HONG KONG CH CH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APNEARX
APNEA SCIENCE CORPORATION 510(k) NO: K113569(ABBREVIATED)
ATTN: GARY MOCNIK PHONE NO : 949 433 0413
49 COASTAL OAK SE DECISION MADE: 01-MAR-12
ALISO VIEJO CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSPORT CULTURE MEDIUM DEVICE
PURITAN MEDICAL PRODUCTS LLC 510(k) NO: K113249(TRADITIONAL)
ATTN: MEHDI KARAMCHI PHONE NO : 207 876 3311
31 SCHOOL STREET P.O. BOX 149 SE DECISION MADE: 01-MAR-12
GUILFORD ME 04443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYING"SONO"/SONOLONG"
PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K113188(TRADITIONAL)
ATTN: CHRISTIAN G QUASS PHONE NO : 497 704 9291
KARL-HALL-STRASSE 1 SE DECISION MADE: 01-MAR-12
GEISINGEN GM 78187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
CHENGDU XINJIN SHIFENG MED APPRATU510(k) NO: K111841(TRADITIONAL)
ATTN: XINGLONG TIAN PHONE NO : 862 862 812121
WANJIE VILLAGE, XINPING TOWN, XINJSE DECISION MADE: 01-MAR-12
CHENGDU CITY CH CH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUCLID (TM) TIER 1-GW ACCESS SYSTEM
HOUSTON MEDICAL ROBOTICS 510(k) NO: K111426(TRADITIONAL)
ATTN: DARLA J ELKIN PHONE NO : 281 450 8163
42 NORTH CHANTSONG CIRCLE SE DECISION MADE: 01-MAR-12
THE WOODLANDS TX 77382 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...
ASTRA TECH INC. 510(k) NO: K113003(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847 560 4406
8944 TAMAROA TERRACE SE DECISION MADE: 01-MAR-12
SKOKIE IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUET MAGNA
DIREX SYSTEMS CORP. 510(k) NO: K111947(TRADITIONAL)
ATTN: LARISA GERSHTEIN PHONE NO : 888 874 7837
437 TURNPIKE ST. SE DECISION MADE: 01-MAR-12
CANTON MA 02021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AONGEN DENTAL COLLAGEN MATRIX
AEON ASTRON EUROPE B.V. 510(k) NO: K112568(TRADITIONAL)
ATTN: HORNG JI LAI PHONE NO : 317 133 22280
NIELS BOHRWEG 11-13 SE DECISION MADE: 01-MAR-12
LEIDEN NL 2333 CA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXMIXING BLOCK
MAXTEC, INC. 510(k) NO: K113232(TRADITIONAL)
ATTN: TAMMY LAVERY PHONE NO : 801 327 9870
6526 SOUTH COTTONWOOD ST. SE DECISION MADE: 01-MAR-12
SALT LAKE CITY UT 84107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CURAD COMPRESSION HOSIERY
MEDLINE, INDUSTRIES, INC. 510(k) NO: K112769(TRADITIONAL)
ATTN: MATT CLAUSEN PHONE NO : 847 643 4785
ONE MEDLINE PLACE SE DECISION MADE: 01-MAR-12
MUNDELEIN IL 60060 510(k) STATEMENT
DEVICE: RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM
MAKO SURGICAL CORPORATION 510(k) NO: K112507(TRADITIONAL)
ATTN: DIONNE SANDERS PHONE NO : 954 628 0655
2555 DAVIE ROAD SE DECISION MADE: 01-MAR-12
FORT LAUDERDALE FL 33317 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
FOOTPRINT MEDICAL INC. 510(k) NO: K120304(SPECIAL)
ATTN: CLYDE BAKER PHONE NO : 210 226 2600
1203 CAMDEN STREET SE DECISION MADE: 01-MAR-12
SAN ANTONIO TX 78215 510(k) STATEMENT
DEVICE: PAIN-AID
PDI WORKS, LLC. 510(k) NO: K113037(TRADITIONAL)
ATTN: THU-HA DUNCAN PHONE NO : 423 303 9981
2150 SOUTH LEE HIGHWAY SE DECISION MADE: 01-MAR-12
CLEVELAND TN 37311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR
HEALTH & LIFE CO., LTD. 510(k) NO: K113238(TRADITIONAL)
ATTN: SARAH SU PHONE NO : 886 282 271300
9F, NO.186, JIAN YI ROAD SE DECISION MADE: 01-MAR-12
ZHONGHE DISTRICT, NEW TAIPEI TW510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE
BIOM'UP SAS 510(k) NO: K103081(TRADITIONAL)
ATTN: VALERIE CENTIS PHONE NO : 330 486 573610
8, ALLEE IRENE JOLIOT-CURIE SE DECISION MADE: 02-MAR-12
ST-PRIEST FR 69800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLITAIRE FR REVASCULARIZATION DEVICE
MICRO THERAPEUTICS DBA EV3 NEUROVA510(k) NO: K113455(TRADITIONAL)
ATTN: LAURA HEATON PHONE NO : 949 837 3700
9775 TOLEDO WAY SE DECISION MADE: 02-MAR-12
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE VINYL EXAM GLOVE, POWDER FREE
FULL SYNERGY MEDICAL PRODUCTS INC 510(k) NO: K113797(ABBREVIATED)
ATTN: ELIZABETH DENG PHONE NO : 909 465 9188
5748 EAGLEWOOD PLACE SE DECISION MADE: 02-MAR-12
RANCHO CUCAMONGA CA 91739 510(k) STATEMENT
DEVICE: SPEE-DEE PATCH
PULPDENT CORPORATION 510(k) NO: K113617(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617 926 6666
80 Oakland St SE DECISION MADE: 02-MAR-12
WATERTOWN MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLIDER PTCA BALLOON CATHETER
TRIREME MEDICAL INC 510(k) NO: K111544(TRADITIONAL)
ATTN: SHIVA ARDAKANI PHONE NO : 925 931 1300
7060 KNOLL CENTER PARKWAY SUITE 30SE DECISION MADE: 02-MAR-12
PLEASANTON CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3MP MONOCHROME LCD MONITOR, RADIFORCE GX40
EIZO NANAO CORPORATION 510(k) NO: K113784(TRADITIONAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 817 627 42468
153 SHIMOKASHIWANO SE DECISION MADE: 02-MAR-12
IIAKUSAN JA 924-8566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KNOTILUS ANCHOR SYSTEM
T.A.G. MEDICAL PRODUCTS CORPORATIO510(k) NO: K113297(TRADITIONAL)
ATTN: GEORGE J HATTUB PHONE NO : 508 479 6116
291 HILLSIDE AVE. SE DECISION MADE: 02-MAR-12
SOMERSET MA 02726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HELICOBACTER PYLORI ELISA IGG TEST KIT
GOLD STANDARD DIAGNOSTICS 510(k) NO: K110745(TRADITIONAL)
ATTN: NAPOLEON MONCE PHONE NO : 530 759 8000
2851 SPAFFORD SE DECISION MADE: 02-MAR-12
Davis CA 95618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENUS FREEZE (MP)2 SYSTEM
VENUS CONCEPT LTD 510(k) NO: K111670(TRADITIONAL)
ATTN: YORAM LEVY PHONE NO : 972 463 88837
31 HAAVODA ST SE DECISION MADE: 02-MAR-12
BINYAMINA IS 30500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LASER HELMET
THERADOME INC. 510(k) NO: K113097(TRADITIONAL)
ATTN: LARRY PETERSEN PHONE NO : 303 489 2500
1001 BEAR ISLAND RD, SUITE 136 SE DECISION MADE: 02-MAR-12
SUMMERVILLE SC 29483 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
ST. JUDE MEDICAL 510(k) NO: K113584(TRADITIONAL)
ATTN: BRYAN COWELL PHONE NO : 978 577 3473
4 ROBBINS ROAD SE DECISION MADE: 02-MAR-12
WESTFORD MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-THV SYSTEM
PAIEON, INC. 510(k) NO: K113594(TRADITIONAL)
ATTN: EREZ BEN-ZVI PHONE NO : 972 391 50000
22 HAMELACHA ST., P.O.B. 11355 SE DECISION MADE: 02-MAR-12
ROSH HAAYIN IS 48901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-CARE INFRARED EAR THERMOMETER
E-CARE TECHNOLOGY CORPORATION 510(k) NO: K113095(TRADITIONAL)
ATTN: KIN-YUAN KO PHONE NO : 866 355 34996
8F-11 NO. 35 HSIN-TAI ROAD SE DECISION MADE: 02-MAR-12
CHUBEI TW 30252 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY
AALTO SCIENTIFIC LTD. 510(k) NO: K111964(TRADITIONAL)
ATTN: DESSI LYAKOV PHONE NO : 760 431 6942
1959 KELLOGG AVE. SE DECISION MADE: 02-MAR-12
CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CS 1600 INTRAORAL CAMERA
CARESTREAM HEALTH,INC. 510(k) NO: K111423(TRADITIONAL)
ATTN: DANIEL HOEFER PHONE NO : 770 226 3287
1765 THE EXCHANGE SE DECISION MADE: 02-MAR-12
ATLANTA GA 30339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE)
LD TECHNOLOGY LLC 510(k) NO: K113264(TRADITIONAL)
ATTN: ABBERT MAAREK PHONE NO : 305 397 9900
100 N. Bicayne Blvd Suite 500 SE DECISION MADE: 02-MAR-12
Miami FL 33132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELTAMAXX 18 MICROCOIL SYSTEM
CODMAN AND SHURTLEFF, INC. 510(k) NO: K120274(SPECIAL)
ATTN: KIM FONDA PHONE NO : 408 433 1420
325 PARAMOUNT DR. SE DECISION MADE: 02-MAR-12
RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR
FULL SYNERGY MEDICAL PRODUCTS INC 510(k) NO: K113750(ABBREVIATED)
ATTN: ELIZABETH DENG PHONE NO : 909 465 9188
5748 EAGLEWOOD PLACE SE DECISION MADE: 05-MAR-12
RANCHO CUCAMONGA CA 91739 510(k) STATEMENT
DEVICE: VIRTUOSO SYSTEM FOR IHC PR (IE2)
VENTANA MEDICAL SYSTEMS, INC. 510(k) NO: K111869(TRADITIONAL)
ATTN: TROY QUANDER PHONE NO : 520 229 4184
1910 EAST INNOVATION PARK DR. SE DECISION MADE: 05-MAR-12
TUCSON AZ 85755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TI-MAX X TURBINE
NAKANISHI, INC. 510(k) NO: K113655(TRADITIONAL)
ATTN: DIANE RUTHERFORD PHONE NO : 972 480 9554
1201 RICHARDSON DRIVE SUITE 280 SE DECISION MADE: 05-MAR-12
RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLIF CAGE
EISERTECH, LLC 510(k) NO: K113478(ABBREVIATED)
ATTN: LUKAS EISERMANN PHONE NO : 888 262 2817
2555 FRONT STREET SE DECISION MADE: 05-MAR-12
SAN DIEGO CA 92103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYMBIQ INFUSION AND ADMINSTRATION SET
HOSPIRA, INC. 510(k) NO: K110901(TRADITIONAL)
ATTN: RAY SILKAITIS PHONE NO : 224 212 4897
275 NORTH FIELD DR. SE DECISION MADE: 05-MAR-12
LAKE FOREST IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI
SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K111792(TRADITIONAL)
ATTN: KAREN E WARDEN, PHD PHONE NO : 440 729 8457
8202 SHERMAN ROAD SE DECISION MADE: 05-MAR-12
CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE
TERUMO (PHILIPPINES) CORPORATION 510(k) NO: K113422(SPECIAL)
ATTN: SANDI HARTKA PHONE NO : 410 392 7241
#124 EAST MAIN AVE. LAGUNA TECHNOPSE DECISION MADE: 05-MAR-12
BINAN, LAGUNA RP 4026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIME-LITE II
PULPDENT CORPORATION 510(k) NO: K113711(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617 926 6666
80 Oakland St SE DECISION MADE: 05-MAR-12
WATERTOWN MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
BAYER HEALTHCARE 510(k) NO: K111268(TRADITIONAL)
ATTN: WEIPING ZHONG PHONE NO : 574 257 3075
430 SOUTH BEIGER STREET SE DECISION MADE: 06-MAR-12
MISHAWAKA IN 46544 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE VINYL EXAM GLOVE, POWDERED
FULL SYNERGY MEDICAL PRODUCTS INC 510(k) NO: K113790(ABBREVIATED)
ATTN: ELIZABTEH DENG PHONE NO : 909 465 9188
5748 EAGLEWOOD PLACE SE DECISION MADE: 06-MAR-12
RANCHO CUCAMONGA CA 91739 510(k) STATEMENT
DEVICE: KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED
MAYER LABORATORIES, INC. 510(k) NO: K113686(ABBREVIATED)
ATTN: DAVID P MAYER PHONE NO : 510 229 5300
1950 ADDISON STREET, SUITE 101 SE DECISION MADE: 06-MAR-12
BERKELY CA 94704 1182 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVATOR V-E
ACTIVATOR METHODS INTERNATIONAL LT510(k) NO: K112606(TRADITIONAL)
ATTN: ARLAN W FUHR PHONE NO : 602 224 0220
2950 N. SEVENTH ST. SE DECISION MADE: 06-MAR-12
PHOENIX AZ 85014 510(k) STATEMENT
DEVICE: NEO NEST
DENOVO PROUCTS LLC 510(k) NO: K112547(TRADITIONAL)
ATTN: DALE WALTERS PHONE NO : 239 245 7030
17051 ALICO COMMERCE CT. #3 SE DECISION MADE: 06-MAR-12
FT. MYERS FL 33967 510(k) STATEMENT
DEVICE: FORESIGHT U120 URINE ANALYZER
ACON LABORATORIES, INC. 510(k) NO: K120124(SPECIAL)
ATTN: QIYI XIE PHONE NO : 858 875 8011
10125 Mesa Rim Road SE DECISION MADE: 06-MAR-12
SAN DIEGO CA 92121 510(k) STATEMENT
DEVICE: SONICEYE ULTRASOUND TRANSDUCER
BLACKTOE MEDICAL III, INC. 510(k) NO: K113832(ABBREVIATED)
ATTN: KENDRA RATHKEY PHONE NO : 503 476 7049
8305 CREEKSIDE PLACE SUITE C SE DECISION MADE: 06-MAR-12
BEAVERTON OR 97008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERASAGE HEATING PAD
THERASAGE CORPORATION 510(k) NO: K120254(TRADITIONAL)
ATTN: ROBERT BESNER PHONE NO : 888 416 4441
21000 Boca Rio Road, Suite A21-C SE DECISION MADE: 06-MAR-12
BOCA RATON FL 33433 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
HONGXIN PLASTIC PRODUCTS CO., LTD 510(k) NO: K120358(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
RM 1606 BUILDING, 1 JIAN XIANG YUASE DECISION MADE: 06-MAR-12
ROAD HAI DI, BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NC TREK OTW CORONARY DILATATION CATHETER
ABBOTT VASCULAR 510(k) NO: K113464(TRADITIONAL)
ATTN: SUZANNE REDMAN PHONE NO : 951 914 3243
26531 YNEZ ROAD P.O. BOX 9018 SE DECISION MADE: 06-MAR-12
TEMECULA CA 92591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOLOGIC VISCERAL FAT SOFTWARE
HOLOGIC, INC. 510(k) NO: K113356(TRADITIONAL)
ATTN: EILEEN M BOYLE PHONE NO : 781 999 7781
35 CROSBY DR. SE DECISION MADE: 06-MAR-12
BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOOTPRINT ULTRA PK SUTURE ANCHOR
SMITH & NEPHEW, INC. 510(k) NO: K113274(TRADITIONAL)
ATTN: MELISSA EGAN PHONE NO : 508 261 3645
150 MINUTEMAN RD. SE DECISION MADE: 06-MAR-12
ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVI ERGON-X HF
VIVI S.R.L. 510(k) NO: K120318(TRADITIONAL)
ATTN: GUIDO BONAPACE PHONE NO : 390 542 683903
VIA BORGO SANTA CRISTINA ,12 SE DECISION MADE: 06-MAR-12
IMOLA IT 40026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESENIUS 2008T HEMODIALYSIS MACHINE
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K120505(SPECIAL)
ATTN: DENISE OPPERMANN PHONE NO : 781 699 4479
920 WINTER STREET SE DECISION MADE: 06-MAR-12
WALTHAM MA 02451 1457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPSY POSITIONER
FUJI FILM MEDICAL SYSTEMS 510(k) NO: K113284(TRADITIONAL)
ATTN: KIMERLY A SHARP PHONE NO : 203 602 3665
419 WEST AVE. SE DECISION MADE: 07-MAR-12
STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEXERYL CREAM
PIERRE FABRE MEDICAL DEVICES 510(k) NO: K113807(TRADITIONAL)
ATTN: DIANE MANDELL HORWITZ PHONE NO : 703 307 2921
1129 TWENTIETH ST., NW SUITE 600 SE DECISION MADE: 07-MAR-12
WASHINGTON DC 20036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PUREGRAFT 850/PURE SYSTEM
CYTORI THERAPEUTICS, INC. 510(k) NO: K113255(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858 458 0900
3020 CALLAN ROAD SE DECISION MADE: 07-MAR-12
SAN DIEGO CA 92121 1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVANT, MOBILC CARDIAC TELEMETRY
CORVENTIS, INC. 510(k) NO: K113372(SPECIAL)
ATTN: KATHLEEN LUNDBERG PHONE NO : 651 925 3807
1410 ENERGY PARK DRIVE SUITE 1 SE DECISION MADE: 07-MAR-12
Saint Paul MN 55108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HILLA DIGITAL TRANSFERS
HILLA TECHNOLOGIES, INC. 510(k) NO: K113575(TRADITIONAL)
ATTN: CAROLYN M PRIMUS PHONE NO : 941 753 9737
7046 OWL'S NEST TERRACE SE DECISION MADE: 07-MAR-12
BRADENTON FL 34203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPER SEAL TOOTH DESENSITIZER
PHOENIX DENTAL, INC. 510(k) NO: K120109(TRADITIONAL)
ATTN: JEFFREY S COX PHONE NO : 810 750 2328
3452 WEST THOMPSON RD. SE DECISION MADE: 07-MAR-12
FENTON MI 48430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM
PHYGEN, LLC 510(k) NO: K120355(SPECIAL)
ATTN: HARTMUT LOCH PHONE NO : 949 752 7885
2301 Dupont Drive, Suite 510 SE DECISION MADE: 07-MAR-12
Irvine CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOVISION
PERIDOT TECHNOLOGIES NY INC 510(k) NO: K113082(TRADITIONAL)
ATTN: OMAR BARLAS PHONE NO : 718 424 0633
9131 QUEENS BLVD. SUITE U SE DECISION MADE: 08-MAR-12
ELMHURST NY 11373 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IFS LASER SYSTEM
ABBOTT MEDICAL OPTICS INC 510(k) NO: K113151(TRADITIONAL)
ATTN: KESLEY E GALLAGHER PHONE NO : 714 247 8930
1700 EAST SAINT ANDREW PL SE DECISION MADE: 08-MAR-12
SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWER ADAPTOR INSTRUMENT ACCESSORY
STRYKER CORP. 510(k) NO: K120434(SPECIAL)
ATTN: TIFFANI ROGERS PHONE NO : 201 760 8206
2 PEARL COURT SE DECISION MADE: 08-MAR-12
ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUADRASPHERE 30 TO 60
BIOSPHERE MEDICAL, INC. 510(k) NO: K113822(SPECIAL)
ATTN: LINDA J VARROSO PHONE NO : 781 681 7900
1050 HINGHAM ST. SE DECISION MADE: 08-MAR-12
ROCKLAND MA 02370 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES
ALMA LASERS INC. 510(k) NO: K113810(TRADITIONAL)
ATTN: TATIANA EPSTEIN PHONE NO : 925 895 1200
485 HALF DAY RD. SUITW NO. 100 SE DECISION MADE: 08-MAR-12
BUFFALO GROVE IL 60089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE
VIDACARE CORPORATION 510(k) NO: K113872(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949 262 0411
3722 AVE. SAUSALITO SE DECISION MADE: 08-MAR-12
IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIASYS 450
AMS 510(k) NO: K113131(TRADITIONAL)
ATTN: STEFANO CORRADI PHONE NO : 390 774 3544
17/A VIA E. BARSANTI SE DECISION MADE: 08-MAR-12
GUIDONIA, ROME IT I-00012 510(k) STATEMENT
DEVICE: ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED
ARTHREX, INC. 510(k) NO: K120044(SPECIAL)
ATTN: COURTNEY SMITH PHONE NO : 239 643 5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 08-MAR-12
NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR
JIANGSU YUYUE MEDICAL EQUIPMENT & 510(k) NO: K120526(TRADITIONAL)
ATTN: NED DEVINE PHONE NO :
333 PFINGSTEN ROAD SE DECISION MADE: 08-MAR-12
NORTHBROOK IL 60062 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MICT TSH
MAGNABIOSCIENCES, LLC 510(k) NO: K110761(TRADITIONAL)
ATTN: JAMES L WYATT PHONE NO : 858 481 4400
6325 LUSK BLVD SE DECISION MADE: 09-MAR-12
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCEND SHOULDER SYSTEM
TORNIER, INC. 510(k) NO: K113413(SPECIAL)
ATTN: BRAHIM HADRI PHONE NO : 781 249 8030
7701 FRANCE AVE SOUTH SUITE 600 SE DECISION MADE: 09-MAR-12
EDINA MN 55435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LANX SPINAL FIXATION SYSTEM
LANX, LLC 510(k) NO: K120399(SPECIAL)
ATTN: MICHAEL FUNK PHONE NO : 303 443 7500
310 INTERLOCKEN PARKWAY STE 120 SE DECISION MADE: 09-MAR-12
BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMO-CATH 10F, HEMO-CATH 12.5F
MEDICAL COMPONENTS INC 510(k) NO: K113487(SPECIAL)
ATTN: JEAN CALLOW PHONE NO : 215 256 4201
1499 DELP DRIVE SE DECISION MADE: 09-MAR-12
HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIPELINE TOTAL HIP SYSTEM
PIPELINE ORTHOPEDICS 510(k) NO: K112802(TRADITIONAL)
ATTN: TERRY POWELL PHONE NO : 703 562 9800
901 KING STREET, SUITE 200 SE DECISION MADE: 09-MAR-12
ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRONY RESPIRATORY TRACKING SYSTEM
ACCURAY INCORPORATED 510(k) NO: K120233(TRADITIONAL)
ATTN: ANNE SCHLAGENHAFT PHONE NO : 408 716 4600
1310 CHESAPEAKE TERRACE SE DECISION MADE: 09-MAR-12
SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS
NOVA BIOMEDICAL CORPORATION 510(k) NO: K112638(TRADITIONAL)
ATTN: PAUL W MACDONALD PHONE NO : 781 894 0800
200 Prospect St SE DECISION MADE: 09-MAR-12
WALTHAM MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE
KIMBERLY-CLARK CORP. 510(k) NO: K113423(TRADITIONAL)
ATTN: LESTER F PADILLA PHONE NO : 678 352 6766
1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 09-MAR-12
ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HBIDB - HUMAN BRIAN INDEX SOFTWARE
CORSCIENCE GMBH & CO. KG 510(k) NO: K112077(TRADITIONAL)
ATTN: PATRIK R KAREM PHONE NO : 412 372 8571
700-706 SECO RD SE DECISION MADE: 09-MAR-12
MONROEVILLE PA 15146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL RETRACTORS
SURGICAL INNOVATIONS PLC 510(k) NO: K112659(TRADITIONAL)
ATTN: STEPHEN SEED PHONE NO : 440 113 2307597
CLAYTON WOOD HOUSE, 6 CLAYTON WOODSE DECISION MADE: 09-MAR-12
LEEDS, WEST YORKSHIRE UK LS16 6510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED CONCENTIRC MICROCATHETER
CONCENTRIC MEDICAL, INC. 510(k) NO: K113260(SPECIAL)
ATTN: KIRSTEN VALLEY PHONE NO : 650 810 1707
301 E. EVELYN AVE. SE DECISION MADE: 09-MAR-12
MOUNTAIN VIEW CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SATURN 8000
NEW MEDICAL CO., LTD. 510(k) NO: K120380(TRADITIONAL)
ATTN: JUN-HSIUNG LIN PHONE NO : 909 244 6562
1441 KEM WAY SE DECISION MADE: 09-MAR-12
WALNUT CA 91789 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QLAB QUANTIFICATION SOFTWARE
PHILIPS HEALTHCARE GROUP 510(k) NO: K120525(SPECIAL)
ATTN: PENNY GRECO PHONE NO : 978 659 4615
3000 MINUTEMAN ROAD SE DECISION MADE: 09-MAR-12
ANDOVER MA 01810 7324 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ADAPTIVE WEDGE
ADAPTIVE SPECIALTY, LLC 510(k) NO: K110662(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512 590 5810
1001 OAKWOOD BLVD SE DECISION MADE: 12-MAR-12
ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIANCE LUMBAR IBF SYSTEM
RELIANCE MEDICAL SYSTEMS, LLC 510(k) NO: K113540(TRADITIONAL)
ATTN: BRET M BERRY PHONE NO : 801 718 7467
545 SOUTH 500 WEST SUITE 100 SE DECISION MADE: 12-MAR-12
BOUNTIFUL UT 84010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K113624(TRADITIONAL)
ATTN: JOE SHIA PHONE NO : 240 505 7880
504 EAST DIAMOND AVE SUITE F SE DECISION MADE: 12-MAR-12
GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WILDCAT CATHETER
AVINGER, INC. 510(k) NO: K113838(TRADITIONAL)
ATTN: SEVRINA CIUCCI PHONE NO : 650 241 7900
400 CHESAPEAKE DRIVE SE DECISION MADE: 12-MAR-12
REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISUAL-ICE CRYOABLATION SYSTEM
GALIL MEDICAL INC. 510(k) NO: K113860(TRADITIONAL)
ATTN: AMY MCKINNEY PHONE NO : 651 287 5096
63 CHICORY CT. SE DECISION MADE: 12-MAR-12
LAKE JACKSON TX 77566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAUMA INTERNAL FIXATION SYSTEMS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K111663(TRADITIONAL)
ATTN: SUZANA OTANO PHONE NO : 305 269 6386
700 ORTHOPAEDIC DRIVE SE DECISION MADE: 12-MAR-12
WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIONEER POSTERIOR CERVICO THORACIC SYSTEM
PIONEER SURGICAL TECHNOLOGY, INC. 510(k) NO: K112757(SPECIAL)
ATTN: EMILY M DOWNS PHONE NO : 906 225 5602
375 RIVER PARK CIRCLE SE DECISION MADE: 12-MAR-12
MARQUETTE MI 49855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER
NIPRO MEDICAL CORPORATION 510(k) NO: K113429(SPECIAL)
ATTN: JESSICA OSWALD PHONE NO : 305 599 7174
3150 N.W. 107TH AVE. SE DECISION MADE: 12-MAR-12
MIAMI FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL
ENHATCH ORTHOPAEDICS LLC 510(k) NO: K112663(TRADITIONAL)
ATTN: MICHAEL PHIPPS PHONE NO : 201 377 9129
1050 WALL ST WEST SUITE 340 SE DECISION MADE: 12-MAR-12
LYNDHURST NJ 07071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM
BESTGEN BIOTECH CORP. 510(k) NO: K103116(SPECIAL)
ATTN: STEVEN SHEN PHONE NO : 886 282 272188
7F, NO 186, JIAN-YI ROAD SE DECISION MADE: 13-MAR-12
JUNG-HE, TAIPEI COUNTY TW 235 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION
DELBIO INCORPORATION 510(k) NO: K103329(TRADITIONAL)
ATTN: NICKY PAN PHONE NO : 886 3 3591968
252, SHANGYING ROAD GUISHAN INDUSTSE DECISION MADE: 13-MAR-12
TAOYUAN COUNTY TW 33341 510(k) STATEMENT
DEVICE: MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM
BIOLITEC MEDICAL DEVICES, INC 510(k) NO: K113688(TRADITIONAL)
ATTN: HARRY HAYES PHONE NO : 413 250 0779
1349 MAIN ROAD SE DECISION MADE: 13-MAR-12
GRANVILLE MA 01034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS
TORNIER 510(k) NO: K112144(SPECIAL)
ATTN: SEVERINE BONNETON PHONE NO : 003 347 6613500
161 RUE LAVOISIER SE DECISION MADE: 13-MAR-12
MONTBONNOT, SAINT-ISMIER FR 383510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE COROENT NO-PROFILE SYSTEM
NUVASIVE, INC. 510(k) NO: K112561(SPECIAL)
ATTN: SHEILA BRUSCHI PHONE NO : 858 320 4515
7475 LUSK BLVD SE DECISION MADE: 13-MAR-12
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOCOOL (TM) RF ABLATION SYSTEM
BAYLIS MEDICAL CO., INC. 510(k) NO: K111523(TRADITIONAL)
ATTN: MEGHAL KHAKHAR PHONE NO : 905 602 4875
2645 MATHESON BLVD. E SE DECISION MADE: 13-MAR-12
MISSISSAUGA, ONTARIO CA L4W 5S4510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VETA PERITONEAL DIALYSIS CATHETER
PFM MEDICAL, INC 510(k) NO: K113354(TRADITIONAL)
ATTN: SALVADORE PALOMARES PHONE NO : 760 758 8749
1815 Aston Ave Suite 106 SE DECISION MADE: 13-MAR-12
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AILERON INTERSPINOUS FIXATION SYSTEM
LIFE SPINE 510(k) NO: K113157(SPECIAL)
ATTN: RANDY LEWIS PHONE NO : 847 884 6117
2401 Hassell Rd Ste 1535 SE DECISION MADE: 13-MAR-12
HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASFORA BULLET CAGE
MEDICAL DESIGNS, LLC 510(k) NO: K112648(SPECIAL)
ATTN: KRISTI VONDRA PHONE NO : 605 275 1032
1210 W. 18TH ST. SUITE 104 SE DECISION MADE: 13-MAR-12
SIOUX FALLS SD 57104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM
LATEXX MANUFACTURING SDN.BHD. 510(k) NO: K102189(TRADITIONAL)
ATTN: NEIL BURRIS PHONE NO : 303 832 8200
11925 W 1-70 FRONTAGE RD NORTH, SUSE DECISION MADE: 14-MAR-12
WHEAT RIDGE CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOUNDATION SPINAL SYSTEM
THE SKELETAL DESIGN PARTNERSHIP LT510(k) NO: K120074(TRADITIONAL)
ATTN: KAREN E WARDEN, PHD PHONE NO : 440 729 8457
8202 SHERMAN ROAD SE DECISION MADE: 14-MAR-12
CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIAVALVE SAFETY IV CATHETER
SMITHS MEDICAL ASD, INC. 510(k) NO: K113700(TRADITIONAL)
ATTN: BRIAN FARIAS PHONE NO : 603 352 3812
201 WEST QUEEN ST. SE DECISION MADE: 14-MAR-12
SOUTHINGTON CT 06489 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENFLOW IV FLUID WARMER
VITAL SIGNS, INC. 510(k) NO: K112902(TRADITIONAL)
ATTN: STACIE GEFFNER-ATIYA PHONE NO : 973 956 5491
20 CAMPUS RD. SE DECISION MADE: 14-MAR-12
TOTOWA NJ 07512 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE
BM KOREA CO., LTD. 510(k) NO: K111820(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080
951 STARBUCK ST. UNIT J SE DECISION MADE: 14-MAR-12
FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
BIO-RAD LABORATORIES, INC. 510(k) NO: K120439(SPECIAL)
ATTN: JUANG WANG PHONE NO : 510 741 4609
5500 EAST 2ND ST. SE DECISION MADE: 14-MAR-12
BENICIA CA 94510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA
ENCORE MEDICAL, L.P. 510(k) NO: K113756(SPECIAL)
ATTN: TEFFANY HUTTO PHONE NO : 512 832 9500
9800 METRIC BLVD. SE DECISION MADE: 14-MAR-12
AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIR-BAG SYSTEM
NIIGATA MECHATRONICS CO., LTD. 510(k) NO: K112969(TRADITIONAL)
ATTN: TOSHIYA NIMONJI PHONE NO : 81 252 553932
3268-18, SHIMAMI-CHO, KITA-KU SE DECISION MADE: 14-MAR-12
NIIGATA-CITY JA 950-3102 510(k) STATEMENT
DEVICE: ORTHOSIZE
ORTHOSIZE LLC 510(k) NO: K120115(TRADITIONAL)
ATTN: YARMELA PAVLOVIC PHONE NO : 267 675 4618
1835 MARKET STREET, 29TH FLOOR SE DECISION MADE: 14-MAR-12
PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B-GENIN, R-GENIN
BERKELEY ADVANCED BIOMATERIALS, IN510(k) NO: K113791(TRADITIONAL)
ATTN: FRANCOIS GENIN PHONE NO : 510 883 0500
901 GRAYSON ST., SUITE 101 SE DECISION MADE: 15-MAR-12
Berkeley CA 94710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
FULL SYNERGY MEDICAL PRODUCTS INC 510(k) NO: K113749(ABBREVIATED)
ATTN: ELIZABETH DENG PHONE NO : 909 465 9188
5748 EAGLEWOOD PLACE SE DECISION MADE: 15-MAR-12
RANCHO CUCAMONGA CA 91739 510(k) STATEMENT
DEVICE: QUIDEL MOLECULAR INFLUENZA A+B
QUIDEL CORP. 510(k) NO: K113777(TRADITIONAL)
ATTN: RONALD H LOLLAR PHONE NO : 858 552 1100
10165 MCKELLAR CT. SE DECISION MADE: 15-MAR-12
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CITIEFFE TITANIUM NAILING SYSTEM
CITIEFFE 510(k) NO: K113387(TRADITIONAL)
ATTN: CLAUDE BERTHOIN PHONE NO : 386 672 2630
110 E. GRANADA BLVD. SUITE 209 SE DECISION MADE: 15-MAR-12
ORMOND BEACH FL 32176 510(k) STATEMENT
DEVICE: AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH
AGA MEDICAL CORPORATION 510(k) NO: K120120(SPECIAL)
ATTN: RASHMI BHUSHAN PHONE NO : 651 756 5767
5050 NATHAN LANE SE DECISION MADE: 15-MAR-12
PLYMOUTH MN 55433 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAREFUSION NICOLET EDX
CAREFUSION 209, INC. 510(k) NO: K112052(TRADITIONAL)
ATTN: ROBERT BURDGE PHONE NO : 608 829 8655
1850 Deming Way SE DECISION MADE: 15-MAR-12
Middleton WI 53562 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IM-11 PNEUMATIC MICROINJECTOR
NARISHIGE CO., LTD. 510(k) NO: K113712(TRADITIONAL)
ATTN: MITSUKO YONEYAMA PHONE NO : 813 330 88383
27-9 MINAMIKARASUYAMA 4-CHOME SE DECISION MADE: 15-MAR-12
SETAGAYA-KU, TOKYO JA 157-0062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
COVIDIEN 510(k) NO: K111933(TRADITIONAL)
ATTN: JEAN SIMON PHONE NO : 303 305 2435
6135 GUNBARREL AVE. SE DECISION MADE: 15-MAR-12
BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONCENTRIC BALLOON GUIDE CATHETER
CONCENTRIC MEDICAL, INC. 510(k) NO: K112404(TRADITIONAL)
ATTN: KIRSTEN VALLEY PHONE NO : 650 810 1707
301 E. EVELYN AVE. SE DECISION MADE: 15-MAR-12
MOUNTAIN VIEW CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LEVEEN SUPERSLIM NEEDLE ELECTRODE
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K113090(TRADITIONAL)
ATTN: ASHLEY PYLE PHONE NO : 508 683 4359
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 15-MAR-12
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOPULSE RESUSCITATION SYSTEM MODEL 1000
ZOLL CIRCULATION 510(k) NO: K112998(TRADITIONAL)
ATTN: SAM NANAVATI PHONE NO : 408 419 2950
650 Almanor Ave SE DECISION MADE: 15-MAR-12
Sunnyvale CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPIC APPLICATOR
MICROMEDICS, INC. 510(k) NO: K120608(TRADITIONAL)
ATTN: LISE W DURAN PHONE NO : 651 452 1977
1270 EAGAN INDUSTRIAL ROAD SE DECISION MADE: 15-MAR-12
ST. PAUL MN 55121 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CONQUEST 40 PTA DILATATION CATHETER
BARD PERIPHERAL VASCULAR, INC. 510(k) NO: K120660(TRADITIONAL)
ATTN: ASHLEY FICKETT PHONE NO : 480 300 2664
1625 WEST 3RD ST. SE DECISION MADE: 15-MAR-12
TEMPE AZ 85280 1740 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014")
TRIREME MEDICAL INC 510(k) NO: K120677(SPECIAL)
ATTN: SHIVA ARDAKANI PHONE NO : 925 931 1300
7060 KNOLL CENTER PARKWAY SUITE 30SE DECISION MADE: 15-MAR-12
PLEASANTON CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: UNIVERSAL MAXILLARY MOLAR
OCO BIOMEDICAL 510(k) NO: K110337(TRADITIONAL)
ATTN: JACK BLOOM PHONE NO : 505 293 0025
8500 WASHINGTON ST. NE SUITE A-1 SE DECISION MADE: 16-MAR-12
ALBUQUERQUE NM 87113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE NVM5 SYSTEM
NUVASIVE, INC. 510(k) NO: K112718(TRADITIONAL)
ATTN: ELIAS KETCHUM PHONE NO : 858 320 4588
7475 LUSK BLVD SE DECISION MADE: 16-MAR-12
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEFLEX ACRILATO
NUXEN S.R.L. 510(k) NO: K113788(TRADITIONAL)
ATTN: HERNAN ILARI PHONE NO : 541 146 446966
J B JUSTO 9741, PB SE DECISION MADE: 16-MAR-12
BUENOS AIRES AR C1408ALB 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
C.R. BARD INC., BARD ELECTROPHYSIO510(k) NO: K113811(TRADITIONAL)
ATTN: ANASTASIA C RANDALL PHONE NO : 978 323 2348
55 TECHNOLOGY DR. SE DECISION MADE: 16-MAR-12
LOWELL MA 01851 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HORIZON CARDIOLOGY ECG MANAGEMENT
MCKESSON ISRAEL LTD. 510(k) NO: K113515(TRADITIONAL)
ATTN: TOMER LEVY PHONE NO : 972 376 8000
HANECHOSHET 4 SE DECISION MADE: 16-MAR-12
TEL AVIV IS 69710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE
NOBLES MEDICAL TECHNOLOGIES II, IN510(k) NO: K113763(SPECIAL)
ATTN: MARIA HATEGAN PHONE NO : 714 427 0398
17080 Newhope St SE DECISION MADE: 16-MAR-12
Fountain Valley CA 92708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K113766(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650 424 5731
3100 HANSEN WAY SE DECISION MADE: 16-MAR-12
PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1.5T GEM FLEX COIL
NEOCOIL, LLC 510(k) NO: K113474(ABBREVIATED)
ATTN: STEVEN NICHOLS PHONE NO : 262 347 1250
N27 W23910A PAUL RD. SE DECISION MADE: 16-MAR-12
PEWAUKEE WI 53072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE(R) EMBOLIC FILTER
W.L. GORE & ASSOCIATES 510(k) NO: K120480(SPECIAL)
ATTN: MICHELLE ANN WELLS PHONE NO : 800 437 8181
4250 WEST KILTIE LN SE DECISION MADE: 16-MAR-12
FLAGSTAFF AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12
EXACTECH, INC. 510(k) NO: K113320(SPECIAL)
ATTN: VLADISLAVA ZAITSEVA PHONE NO : 352 377 1140
2320 N.W. 66TH CT. SE DECISION MADE: 16-MAR-12
GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHESAPEAKE SPINAL SYSTEM
K2M, INC. 510(k) NO: K120031(SPECIAL)
ATTN: NANCY GIEZEN PHONE NO : 703 777 3155
751 MILLER DR., S.E., SUITE F1 SE DECISION MADE: 16-MAR-12
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P
NIHON KOHDEN AMERICA, INC. 510(k) NO: K120485(SPECIAL)
ATTN: STEVE GEERDES PHONE NO : 949 580 1555
90 ICON ST. SE DECISION MADE: 16-MAR-12
FOOTHILL RANCH CA 92610 1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-CUBE 9
ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K120060(TRADITIONAL)
ATTN: YUCHI CHU PHONE NO : 425 949 4907
10604 NE 38TH PLACE SUITE 229 SE DECISION MADE: 16-MAR-12
KIRKLAND WA 98033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSORB ABSORBALBE STAPLE
INCISIVE SURGICAL, INC. 510(k) NO: K120373(SPECIAL)
ATTN: DAVID HERRIDGE PHONE NO : 952 591 2543
14405 21ST AVE N. SUITE 130 SE DECISION MADE: 16-MAR-12
PLYMOUTH MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDO-EXPRESS (R) HANDPIECE
ESSENTIAL DENTAL SYSTEMS, INC. 510(k) NO: K111541(TRADITIONAL)
ATTN: JEFFREY WAN PHONE NO : 201 487 9090
89 LEUNING STREET SUITE 8 SE DECISION MADE: 16-MAR-12
SOUTH HACKENSACK NJ 07606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FEMTO LDV
SIE AG,SURGICAL INSTUMENT ENGINEER510(k) NO: K112154(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720 962 5412
5401 S. COTTONWOOD CT. SE DECISION MADE: 16-MAR-12
GREENWOOD VILLAGE CO 80121 510(k) STATEMENT
DEVICE: RNARETAIN
ASURAGEN, INC. 510(k) NO: K113420(TRADITIONAL)
ATTN: LUC VAN HOVE PHONE NO : 512 681 5200
2150 WOODWARD ST. SUITE 100 SE DECISION MADE: 16-MAR-12
AUSTIN TX 78744 1840 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROCARDIOGRAPH
EDAN INSTRUMENTS INC 510(k) NO: K120188(SPECIAL)
ATTN: YUE QIUHONG PHONE NO : 867 552 6899197
3/F-B, NANSHAN MEDICAL EQUIPMENTS SE DECISION MADE: 16-MAR-12
SHENZHEN CH 518067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)
HEALTH & LIFE CO., LTD. 510(k) NO: K113239(TRADITIONAL)
ATTN: SARAH SU PHONE NO : 886 282 271300
9F, NO.186, JIAN YI ROAD SE DECISION MADE: 16-MAR-12
ZHONGHE DISTRICT, NEW TAIPEI TW510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD BACTEC PLUS AEROBIC/F (PLASTIC)
BECTON, DICKINSON AND COMPANY 510(k) NO: K113558(TRADITIONAL)
ATTN: PAUL SWIFT PHONE NO : 410 316 4905
7 LOVETON CIRCLE MC 614 SE DECISION MADE: 16-MAR-12
SPARKS MD 21043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
ZIBO TENGYUE PLASTIC PRODUCTS CO.,510(k) NO: K110536(TRADITIONAL)
ATTN: FRANK LIU PHONE NO : 909 548 4828
12390 EAST END AVENUE SE DECISION MADE: 19-MAR-12
CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METHA HIP SYSTEM
AESCULAP IMPLANT SYSTEMS, LLC 510(k) NO: K112682(TRADITIONAL)
ATTN: KATHY A RACOSKY PHONE NO : 610 984 9291
3773 CORPORATE PARKWAY SE DECISION MADE: 19-MAR-12
CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
C.R. BARD, INC. 510(k) NO: K113808(TRADITIONAL)
ATTN: HENRY BOLAND PHONE NO : 801 595 0700
605 NORTH 5600 WEST SE DECISION MADE: 19-MAR-12
SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FILTEK BULK FILL FLOWABLE RESTORATIVE
3M ESPE DENTAL PRODUCTS 510(k) NO: K120453(TRADITIONAL)
ATTN: SCOTT ERICKSON PHONE NO : 651 736 9883
3M CENTER; BLDG 260-2A-11 SE DECISION MADE: 19-MAR-12
ST. PAUL MN 55144 1000 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PLEURX PERITONEAL CATHETER SYSTEM
CAREFUSION 510(k) NO: K113854(TRADITIONAL)
ATTN: JOY GREIDANUS PHONE NO : 847 473 7407
1500 WAUKEGAN ROAD SE DECISION MADE: 19-MAR-12
WAUKEGAN IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CODAN SAFEFEED ENTERAL FEEDING RESERVOIR
CODAN US CORP. 510(k) NO: K112268(TRADITIONAL)
ATTN: JEFF NIELSEN PHONE NO : 714 430 1303
3511 WEST SUNFLOWER AVE. SE DECISION MADE: 19-MAR-12
SANTA ANA CA 92704 6944 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: HIVOX BIOTEK INC.
HIVOX BIOTEK, INC. 510(k) NO: K112392(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 19-MAR-12
HSIN-CHU CITY TW 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)
MARUCHI 510(k) NO: K112078(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080
951 STARBUCK ST. UNIT J SE DECISION MADE: 19-MAR-12
FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARCORRECT SYSTEM
CLEARCORRECT, INC. 510(k) NO: K113618(TRADITIONAL)
ATTN: CHERYL FISHER PHONE NO : 408 410 5920
611 W. 5TH STREET THIRD FLOOR SE DECISION MADE: 19-MAR-12
AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABL90 FLEX
RADIOMETER MEDICAL APS 510(k) NO: K120197(SPECIAL)
ATTN: MARTIN GABLER PHONE NO : 453 827 3114
AAKANDEVEJ 21 SE DECISION MADE: 19-MAR-12
BRONSHOJ DA DK-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN
ST. JUDE MEDICAL 510(k) NO: K120544(SPECIAL)
ATTN: MARLENE PETERSON PHONE NO : 651 756 5162
14901 DEVEAU PL. SE DECISION MADE: 19-MAR-12
MINNETONKA MN 55345 2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35
BIOMET SPINE & BONE HEALING TECHNO510(k) NO: K120557(SPECIAL)
ATTN: MARGARET F CROWE PHONE NO : 973 299 9300
100 INTERPACE PARKWAY SE DECISION MADE: 19-MAR-12
PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEWDEAL INTERPHALANGEAL IMPLANT
NEWDEAL SAS 510(k) NO: K103623(TRADITIONAL)
ATTN: MARILYSE LATOUR PHONE NO : 334 374 75168
IMMEUBLE SEQUOIA 2, 97 ALLEE ALEXASE DECISION MADE: 20-MAR-12
PARC TECHNOLOGIQUE DE LA PRTE F510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V1 SYSTEM
OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K111756(TRADITIONAL)
ATTN: STACY ABBATIELLO KLUESNER PHONE NO : 484 896 5405
3500 CORPORATE PARKWAY P.O. BOX 61SE DECISION MADE: 20-MAR-12
CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIPELINE CR PRIMARY KNEE SYSTEM
PIPELINE ORTHOPEDICS 510(k) NO: K113122(TRADITIONAL)
ATTN: TERRY POWELL PHONE NO : 703 562 9800
901 KING STREET, SUITE 200 SE DECISION MADE: 20-MAR-12
ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER
VASCULAR SOLUTIONS, INC. 510(k) NO: K112100(TRADITIONAL)
ATTN: MATT NIENSTEDT PHONE NO : 763 656 4300
6464 SYCAMORE COURT SE DECISION MADE: 20-MAR-12
MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM
ENDOSCOPIC TECHNOLOGIES, INC. D/B/510(k) NO: K113475(TRADITIONAL)
ATTN: TAMER IBRAHIM PHONE NO : 925 543 2110
2603 CAMINO RAMON SUITE 100 SE DECISION MADE: 20-MAR-12
SAN RAMON CA 94583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAMMOTOME ELITE BIOPSY SYSTEM
DEVICOR MEDICAL PRODUCTS INC. 510(k) NO: K112411(TRADITIONAL)
ATTN: SHAWNA M ROSE PHONE NO : 513 864 9178
300 E. BUSINESS WAY FIFTH FLOOR SE DECISION MADE: 20-MAR-12
CINCINNATI OH 45241 0000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO RT INTERFACE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K120363(TRADITIONAL)
ATTN: CHRISTINE DUNBAR PHONE NO : 925 602 8157
4040 NELSON AVE. SE DECISION MADE: 20-MAR-12
CONCORD CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOBOLT
ARTHREX, INC. 510(k) NO: K120540(SPECIAL)
ATTN: COURTNEY SMITH PHONE NO : 239 643 5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 20-MAR-12
NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM
HEI, INC. 510(k) NO: K102900(TRADITIONAL)
ATTN: GREGORY MATHISON PHONE NO : 218 387 1559
4801 NORTH 63RD. ST. SE DECISION MADE: 21-MAR-12
BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRAUTERINE INSEMINATION (IUI) CATHETER
CATHETER RESEARCH, INC. 510(k) NO: K120154(ABBREVIATED)
ATTN: BABACAR DIOUF PHONE NO : 317 872 0074
5610 W 82nd St SE DECISION MADE: 21-MAR-12
INDIANAPOLIS IN 46278 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL
PULPDENT CORPORATION 510(k) NO: K113818(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617 926 6666
80 Oakland St SE DECISION MADE: 21-MAR-12
WATERTOWN MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR
UPSTREAM PERIPHERAL TECHNOLOGIES 510(k) NO: K112887(TRADITIONAL)
ATTN: JANICE M HOGAN PHONE NO : 267 675 4611
1835 MARKET STREET 29TH FLOOR SE DECISION MADE: 21-MAR-12
PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POSEY BED
J. T. POSEY CO. 510(k) NO: K113357(TRADITIONAL)
ATTN: BONNIE BISHOP PHONE NO : 626 454 2195
5635 PECK RD. SE DECISION MADE: 21-MAR-12
ARCADIA CA 91006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULTOL
SHARP CORPORATION 510(k) NO: K113865(TRADITIONAL)
ATTN: DIANE RUTHERFORD PHONE NO : 972 480 9554
1201 RICHARDSON DRIVE SUITE 280 SE DECISION MADE: 21-MAR-12
RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
UG HEALTHCARE (USA), INC. 510(k) NO: K112005(TRADITIONAL)
ATTN: KEN STANTON PHONE NO : 714 444 2248
1656 SUNFLOWER AVE. SE DECISION MADE: 21-MAR-12
COSTA MESA CA 92626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES
UG HEALTHCARE (USA), INC. 510(k) NO: K112012(TRADITIONAL)
ATTN: KEN STANTON PHONE NO : 714 444 2248
1565 SUNFLOWER AVE. SE DECISION MADE: 21-MAR-12
COSTA MESA CA 92626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL X SERIES
ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K112432(TRADITIONAL)
ATTN: CHARLES W KOLIFRATH PHONE NO : 978 421 9786
269 MILL ROAD SE DECISION MADE: 21-MAR-12
CHELMSFORD MA 01824 4105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
SYNTHES USA 510(k) NO: K120070(TRADITIONAL)
ATTN: ANGELA F LASSANDRO PHONE NO : 610 719 6854
1301 GOSHEN PKWY SE DECISION MADE: 21-MAR-12
WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHYSIOLOGICAL MONITOR, PATIENT MONITOR
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K113441(TRADITIONAL)
ATTN: JENS-PETER SEHER PHONE NO : 497 031 4632086
HEWLETT-PACKARD STR.2 SE DECISION MADE: 22-MAR-12
BOEBLINGEN GM D 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K113798(TRADITIONAL)
ATTN: BETH A ZIS PHONE NO : 978 379 8265
6 TECH DRIVE SE DECISION MADE: 22-MAR-12
ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELLIVUE PATIENT MONITOR
PHILIPS MEDIZIN SYSTEME BOBLINGEN 510(k) NO: K113657(TRADITIONAL)
ATTN: MANFRED STEVER PHONE NO : 497 031 4632186
HEWLETT-PACKARD-STR. 2 SE DECISION MADE: 22-MAR-12
BOBLINGEN GM D-71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K113220(TRADITIONAL)
ATTN: VICKY L HAGENS PHONE NO : 763 255 0303
ONE SCIMED PLACE SE DECISION MADE: 22-MAR-12
MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISI MOBILE MONITORING SYSTEM
SOTERA WIRELESS, INC 510(k) NO: K112478(TRADITIONAL)
ATTN: EBEN GORDON PHONE NO : 858 373 4841
9444 WAPLES STREET SE DECISION MADE: 22-MAR-12
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPACELABS ARKON ANESTHESIA WORKSTATION
SPACELABS HEALTHCARE 510(k) NO: K113051(TRADITIONAL)
ATTN: THOMAS KROENKE PHONE NO : 303 956 4232
P.O. BOX 3018 SE DECISION MADE: 22-MAR-12
NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE
FENWAL, INC. 510(k) NO: K111702(TRADITIONAL)
ATTN: KIM FORCH PHONE NO : 847 550 7909
THREE CORPORATE DRIVE SE DECISION MADE: 22-MAR-12
LAKE ZURICH IL 60047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZSLEEP SLEEP QUALITY RECORDER
PLATINUM TEAM CO., LTD 510(k) NO: K112573(TRADITIONAL)
ATTN: JAMES HO PHONE NO : 886 228 968019
396 DAYE ROAD SE DECISION MADE: 22-MAR-12
TAIPAI TW 11268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENII GI 4000 ELECTROSUGICAL GENERATOR
GENII, INC. 510(k) NO: K113265(TRADITIONAL)
ATTN: JULIE POWELL PHONE NO : 512 327 9997
611 WEST 5TH FLOOR THIRD FLOOR SE DECISION MADE: 22-MAR-12
AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
NIHON KOHDEN AMERICA, INC. 510(k) NO: K113117(SPECIAL)
ATTN: STEVE GEERDES PHONE NO : 949 580 1555
90 ICON ST. SE DECISION MADE: 22-MAR-12
FOOTHILL RANCH CA 92610 1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOLIS 12I
TOKYO BOEKI MEDISYS INC. 510(k) NO: K110520(TRADITIONAL)
ATTN: JAMES M CLINTON PHONE NO : 919 247 0479
5105 FAIROAKS ROAD SE DECISION MADE: 23-MAR-12
DURHAM NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP
ZEPHYR SLEEP TECHNOLOGIES INC 510(k) NO: K103704(ABBREVIATED)
ATTN: SABINA BRUCHLMANN PHONE NO : 403 210 6824
2513 17 ST SE SE DECISION MADE: 23-MAR-12
CALGARY; ALBERTA CA T2L 2K7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
IMRIS, INC. 510(k) NO: K113748(TRADITIONAL)
ATTN: SANJAY SHAH PHONE NO : 204 480 7070
100-1370 SONY PLACE SE DECISION MADE: 23-MAR-12
WINNIPEG, MB CA R3T 1N5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K112377(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 706 7456
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 23-MAR-12
GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
BECTON, DICKINSON AND COMPANY 510(k) NO: K120049(TRADITIONAL)
ATTN: GREGORY P PAYNE PHONE NO : 858 795 7890
10865 ROAD TO THE CURE, SUITE 200 SE DECISION MADE: 23-MAR-12
SAN DIEGO CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM
SONOWAND AS 510(k) NO: K112469(TRADITIONAL)
ATTN: CONSTANCE G BUNDY PHONE NO : 763 574 1976
435 RICE CREEK TERRANCE NE SE DECISION MADE: 23-MAR-12
FRIDLEY MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLADDER SCANNER
MEDA CO. LTD. 510(k) NO: K113304(TRADITIONAL)
ATTN: KAI CHEN PHONE NO : 240 888 4001
13505 BROADFIELD DR. SE DECISION MADE: 23-MAR-12
POTOMAC MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX
BRENNEN MEDICAL, LLC 510(k) NO: K113866(TRADITIONAL)
ATTN: KENNETH B HERLAND PHONE NO : 651 429 7413
1290 HAMMOND RD. SE DECISION MADE: 23-MAR-12
ST. PAUL MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESORB X-G
KLS-MARTIN L.P. 510(k) NO: K112064(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904 641 7746
11201 SAINT JOHNS INDUSTRIAL PARKWSE DECISION MADE: 23-MAR-12
JACKSONVILLE FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-LIPO SYSTEM
CHROMOGENEX TECHNOLOGIES LIMITED 510(k) NO: K111501(TRADITIONAL)
ATTN: PETER R BEVAN PHONE NO : 44 155 4755444
UNITS 1& 2 HEOL RHOSYN PARC DAFEN SE DECISION MADE: 23-MAR-12
LLANELLI, CARMARTHENSHIRE UK SA510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX
NEOORTHO PRODUTOS ORTOPEDICOS S/A 510(k) NO: K113733(TRADITIONAL)
ATTN: KEVIN A THOMAS PHONE NO : 858 792 1235
11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 23-MAR-12
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECULUM, VAGINAL, NONMETAL
WELCH ALLYN, INC. 510(k) NO: K120743(SPECIAL)
ATTN: KEVIN CROSSEN PHONE NO : 315 685 2609
4341 STATE ST. RD. PO BOX 220 SE DECISION MADE: 23-MAR-12
SKANEATELES FALLS NY 13153 0220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYOSURE CONTROL UNIT
HOLOGIC, INC. 510(k) NO: K120593(SPECIAL)
ATTN: SARAH FAIRFIELD PHONE NO : 508 263 8857
250 CAMPUS DRIVE SE DECISION MADE: 23-MAR-12
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APACERAM BONE GRAFT SUBSTITUTE
HOYA CORPORATION 510(k) NO: K120602(SPECIAL)
ATTN: PATSY J TRISLER PHONE NO : 301 652 5344
5600 WISCONSIN AVENUE #509 SE DECISION MADE: 23-MAR-12
CHEVY CHASE MD 20815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALLS M SPINAL SYSTEM
KOREA BONE BANK CO., LTD 510(k) NO: K120538(SPECIAL)
ATTN: APRIL LEE PHONE NO : 714 525 0114
325 N PUENTE ST UNIT B SE DECISION MADE: 23-MAR-12
BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION
CAREFUSION 303,INC. 510(k) NO: K110535(TRADITIONAL)
ATTN: GABRIELA MURANEVICI PHONE NO : 858 617 5889
10020 PACIFIC MESA BLVD SE DECISION MADE: 26-MAR-12
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENUS SPINAL FIXATION SYSTEM
L&K BIOMED CO., LTD 510(k) NO: K120270(TRADITIONAL)
ATTN: HEE KYEONG JOO PHONE NO : 822 262 41475
#1104, ACE HIGH-END TOWER 3 CHA, 3SE DECISION MADE: 26-MAR-12
GEUMCHEON-GU, SEOUL KS 153-803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPLEX 2200 TORC IGG
BIO-RAD LABORATORIES, INC. 510(k) NO: K120572(SPECIAL)
ATTN: JUANG WANG PHONE NO : 510 741 4609
5500 EAST 2ND ST. SE DECISION MADE: 26-MAR-12
BENICIA CA 94510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WOUND PROTECTOR
COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K120061(TRADITIONAL)
ATTN: JOSEPH CANAVAN PHONE NO : 203 492 8032
60 Middletown Ave SE DECISION MADE: 27-MAR-12
North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
ALCON RESEARCH, LTD. 510(k) NO: K112977(ABBREVIATED)
ATTN: CATHERINE GOBLE PHONE NO : 817 551 6816
6201 SOUTH FREEWAY SE DECISION MADE: 27-MAR-12
FORT WORTH TX 76134 2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
VATECH CO., LTD. 510(k) NO: K113672(TRADITIONAL)
ATTN: DAVE KIM PHONE NO : 713 467 2607
12946 KIMBERLEY LN SE DECISION MADE: 27-MAR-12
HOUSTON TX 77079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIFIX P KNOTLESS FIXATION DEVICE
ARTHROCARE CORPORATION 510(k) NO: K120096(TRADITIONAL)
ATTN: CHERYL FREDERICK PHONE NO : 512 391 5751
7000 West William Cannon Drive BLDSE DECISION MADE: 27-MAR-12
Austin TX 78735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANESTHESIA INJECTION TOOL SET
KI WORKS CO., LTD. 510(k) NO: K113247(TRADITIONAL)
ATTN: EILEEN YANG PHONE NO : 824 247 62977
MIGUN TECHNOWOLRD 2 C-DONG 524 #53SE DECISION MADE: 27-MAR-12
YONGSAN-DONG, DAEJEON KS KS 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISIA ONCOLOGY
MEVIS MEDICAL SOLUTIONS AG 510(k) NO: K120484(TRADITIONAL)
ATTN: THOMAS E TYNES PHONE NO : 262 691 9530
N27 W24075 PAUL COURT SUITE 100 SE DECISION MADE: 27-MAR-12
PEWAUKEE WI 53072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESSCAN
RESMED LTD. 510(k) NO: K113815(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858 836 5984
9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 27-MAR-12
SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSULATION TESTER
SPECTRUM SURGICAL SUPPLY CORP. 510(k) NO: K120416(TRADITIONAL)
ATTN: DENNIS A KOVIT PHONE NO : 330 686 4550
4575 HUDSON DR. SE DECISION MADE: 27-MAR-12
STOW OH 44224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABACUS 5
DIATRON US INC 510(k) NO: K112755(TRADITIONAL)
ATTN: MICHAEL SWITZER PHONE NO : 954 790 9550
14026 W. 107TH STREET SE DECISION MADE: 27-MAR-12
LENEXA KS 66215 2005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER PERSONA KNEE SYSTEM
ZIMMER INC. 510(k) NO: K113369(TRADITIONAL)
ATTN: KELLI ANDERSON PHONE NO : 574 371 8087
P.O. BOX 708 SE DECISION MADE: 27-MAR-12
WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICASE GUIDE
MATERIALISE N.V. 510(k) NO: K111558(TRADITIONAL)
ATTN: ALEXANDRA RAZZHIVINA PHONE NO : 321 639 6280
TECHNOLOGIELAAN 15 SE DECISION MADE: 27-MAR-12
LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INDEPENDENCE SPACER
GLOBE MEDICAL, INC. 510(k) NO: K120101(SPECIAL)
ATTN: MERIAM YOUSSEF PHONE NO : 610 930 1800
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 27-MAR-12
AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK
BIO-RAD LABORATORIES, INC. 510(k) NO: K120504(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949 598 1285
9500 JERONIMO RD. SE DECISION MADE: 27-MAR-12
IRVINE CA 92618 2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRIVO MR355
GE HANGWEI MEDICAL SYSTEMS CO., LT510(k) NO: K120778(SPECIAL)
ATTN: RUOQIAN LIU PHONE NO : 861 058 068943
NO.2, YONG CHANG NORTH RD. BEIJINGSE DECISION MADE: 27-MAR-12
BEIJING CH 100176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE PERSONAL LUBRICANT (SILICONE)
ONE 510(k) NO: K110690(ABBREVIATED)
ATTN: SHARON PIETILA PHONE NO : 617 946 2800
12 CHANNEL STREET SE DECISION MADE: 28-MAR-12
BOSTON MA 02210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)
BAYER HEALTHCARE, LLC 510(k) NO: K110587(TRADITIONAL)
ATTN: CHUCK RYAN PHONE NO : 914 333 6736
555 WHITE PLAINS ROAD SE DECISION MADE: 28-MAR-12
TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER
BAYER HEALTHCARE 510(k) NO: K110894(TRADITIONAL)
ATTN: ROGER SONNENBURG PHONE NO : 574 256 3441
430 SOUTH BEIGER STREET SE DECISION MADE: 28-MAR-12
MISHAWAKA IN 46544 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOTONA XP ND: YAG LASER SYSTEM
FOTONA D.D. 510(k) NO: K113702(TRADITIONAL)
ATTN: STOJAN TROST PHONE NO : 386 150 09100
STEGNE 7, SE DECISION MADE: 28-MAR-12
LJUBLJANA SI 1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRAG LATERAL FLOW ASSAY (LFA)
IMMUNO-MYCOLOGICS, INC. 510(k) NO: K112422(TRADITIONAL)
ATTN: SEAN K BAUMAN PHONE NO : 405 360 4669
2700 TECHNOLOGY PLACE SE DECISION MADE: 28-MAR-12
NORMAN OK 73071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELLIPSE PRECICE TRAUMA NAIL SYSTEM
ELLIPSE TECHNOLOGIES, INC. 510(k) NO: K113695(TRADITIONAL)
ATTN: JOHN MCLNTYRE PHONE NO : 949 837 3600
13900 Alton Pkwy Ste 123 SE DECISION MADE: 28-MAR-12
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTPILOT VIEW MODEL MK04500
DRAEGER MEDICAL GMBH 510(k) NO: K103035(TRADITIONAL)
ATTN: JOYCE KILROY PHONE NO : 215 660 2626
3135 QUARRY ROAD SE DECISION MADE: 28-MAR-12
TELFORD PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR
JIANGSU HEALTHY WAY MEDICAL EQUIPM510(k) NO: K112948(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
INDUSTRIAL RESEARCH SOCIETY NO.58 SE DECISION MADE: 28-MAR-12
HSIN CHU CITY TW 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR
JIANGSU HEALTHY MEDICAL EQUIPMENT 510(k) NO: K112950(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
INDUSTRIAL RESEARCH SOCIETY NO.58.SE DECISION MADE: 28-MAR-12
HSIN CHU CITY TW 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTI-ANALYTE CHEMISTRY STANDARDS
VERICHEM LABORATORIES, INC. 510(k) NO: K112834(ABBREVIATED)
ATTN: ANTHONY JAMES DIMONTE PHONE NO : 401 461 0180
90 NARRAGANSETT AVE. SE DECISION MADE: 28-MAR-12
PROVIDENCE RI 02907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUASHIELD CO2 SYSTEM
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K120123(TRADITIONAL)
ATTN: CARROLL L MARTIN PHONE NO : 440 639 4494
5976 HEISELY RD. SE DECISION MADE: 28-MAR-12
MENTOR OH 44060 510(k) STATEMENT
DEVICE: GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL
APEX BIOTECHNOLOGY CORP. 510(k) NO: K113547(TRADITIONAL)
ATTN: HSUE-MEI LEE PHONE NO : 886 356 41952
NO. 7, LI-HSIN ROAD V, HSINCHU SCISE DECISION MADE: 28-MAR-12
HSINCHU TW 30078 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REXIOUS HOOK FIXATION SYSTEMS
DIO MEDICAL CO., LTD. 510(k) NO: K113324(TRADITIONAL)
ATTN: APRIL LEE PHONE NO : 714 525 0114
325 N. PUENTE ST UNIT B SE DECISION MADE: 28-MAR-12
BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESIGLASS PASTE
SHOFU DENTAL CORPORATION 510(k) NO: K112307(TRADITIONAL)
ATTN: DAVID P MORAIS PHONE NO : 760 736 3277
1225 STONE DRIVE SE DECISION MADE: 28-MAR-12
SAN MARCOS CA 92078 510(k) STATEMENT
DEVICE: BD RECYKLEEN SHARPS COLLECTORS
BECTON, DICKINSON AND COMPANY 510(k) NO: K112774(TRADITIONAL)
ATTN: EILEEN HILLER PHONE NO : 201 847 4570
1 BECTON DRIVE MC 372 SE DECISION MADE: 28-MAR-12
FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
EPS BIO TECHNOLOGY CORP. 510(k) NO: K113243(TRADITIONAL)
ATTN: CYNTHIA HUNG PHONE NO : 886 366 86868
NO.8 R&D RD III HSINCHU SCIENCE PASE DECISION MADE: 28-MAR-12
HSINCHU CITY TW 30077 510(k) STATEMENT
DEVICE: AZUR DETACHABLE 18
MICRO VENTION, INC. 510(k) NO: K120630(SPECIAL)
ATTN: CYNTHIA VALENZUELA PHONE NO : 714 247 8000
1311 VALENCIA AVENUE SE DECISION MADE: 28-MAR-12
TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZAVATION IBF SYSTEM
ZAVATION LLC 510(k) NO: K120576(SPECIAL)
ATTN: JOHN WALKER PHONE NO : 601 919 1119
501 AVALON WAY SE DECISION MADE: 28-MAR-12
BRANDON MS 39047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700
BIONIME CORPORATION 510(k) NO: K110737(TRADITIONAL)
ATTN: JIGAR SHAH PHONE NO : 516 482 9001
55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 29-MAR-12
GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MCOMPASS ANORECTAL MANOMETRY SYSTEM
MEDSPIRA, LLC 510(k) NO: K120088(TRADITIONAL)
ATTN: JIM QUACKENBUSH PHONE NO : 612 789 0013
2718 SUMMER STREET NE SE DECISION MADE: 29-MAR-12
MINNEAPOLIS MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ACDS
ISOPURE CORP. 510(k) NO: K120005(SPECIAL)
ATTN: KEVIN GILLESPIE PHONE NO : 502 722 1000
141 CITIZENS BLVD. SE DECISION MADE: 29-MAR-12
SIMPSONVILLE KY 40067 6548 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFANT ARRAY
ADVANCED IMAGING RESEARCH DBA SREE510(k) NO: K113365(TRADITIONAL)
ATTN: RAVI SPRINIVASAN PHONE NO : 216 426 1461
PO BOX 603220 SE DECISION MADE: 29-MAR-12
CLEVELAND OH 44103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN
ACTA MEDICAL L.L.C. 510(k) NO: K112863(TRADITIONAL)
ATTN: AARON COMPTON PHONE NO : 214 533 1416
929 ARBOR DOWNS DRIVE SE DECISION MADE: 29-MAR-12
PLANO TX 75023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM
SHEN WEI (USA), INC. 510(k) NO: K113233(TRADITIONAL)
ATTN: ALBERT LI PHONE NO : 510 429 8692
33278 CENTRAL AVE., SUITE 102 SE DECISION MADE: 29-MAR-12
UNION CITY CA 94587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
STRYKER CORP. 510(k) NO: K113327(TRADITIONAL)
ATTN: ESTELA CELI PHONE NO : 201 831 6461
325 CORPORATE DRIVE SE DECISION MADE: 29-MAR-12
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFRARED EAR THEROMETER
FUDAKANG INDUSTRIAL CO LTD 510(k) NO: K111703(TRADITIONAL)
ATTN: DANIEL NAM PHONE NO : 213 626 1544
205 S. BROADWAY, SUITE 718 SE DECISION MADE: 29-MAR-12
LOS ANGELES CA 90012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOCKING COMPRESSION PLATE SYSTEM
SHANGHAI MICROPORT ORTHOPEDICS CO.510(k) NO: K112798(TRADITIONAL)
ATTN: JASON MA PHONE NO : 862 138 954600
588 TIANXIONG RD. BUILDING 23 SE DECISION MADE: 29-MAR-12
SHANGHAI CH 201318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS
IMPERIAL SURGICAL LTD. 510(k) NO: K112702(TRADITIONAL)
ATTN: KATHRYN RONALDS PHONE NO :
4 INNOVATION DRIVE SE DECISION MADE: 29-MAR-12
DUNDAS CA L9H 7P3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K112538(TRADITIONAL)
ATTN: HYMAN KATZ PHONE NO : 973 852 0158
4 HENDERSON DRIVE SE DECISION MADE: 29-MAR-12
WEST CALDWELL NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIGER SPINE SYSTEM
CORELINK LLC 510(k) NO: K113058(TRADITIONAL)
ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800
1331 H STREET 12TH FLOOR SE DECISION MADE: 29-MAR-12
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
MEDTRONIC MINIMED 510(k) NO: K120206(SPECIAL)
ATTN: TAMAR JAGHASBANIAN PHONE NO : 818 576 3143
18000 DEVONSHIRE ST. SE DECISION MADE: 29-MAR-12
NORTHRIDGE CA 91325 1219 510(k) STATEMENT
DEVICE: TOSHIBA 1.5T QD HEAD COIL
QUALITY ELECTRODYNAMICS 510(k) NO: K120627(TRADITIONAL)
ATTN: CHRISTIE ZYDYK PHONE NO : 440 484 2228
700 BETA DRIVE SUITE 100 SE DECISION MADE: 29-MAR-12
MAYFIELD VILLAGE OH 44143 0000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM
OSTIAL CORPORATION 510(k) NO: K120738(SPECIAL)
ATTN: KAITLIN VON HOFFMANN PHONE NO : 650 903 9100
510 CLYDE AVENUE SE DECISION MADE: 29-MAR-12
MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
SPACELABS MEDICAL, INC. 510(k) NO: K120616(SPECIAL)
ATTN: THOMAS KROENKE PHONE NO : 303 956 4232
PO BOX 3018 SE DECISION MADE: 29-MAR-12
NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VPAP ST-A
RESMED LTD. 510(k) NO: K113288(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858 836 5984
9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 29-MAR-12
SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
ABBOTT DIABETES CARE INC. 510(k) NO: K120568(SPECIAL)
ATTN: ARUL STERLIN PHONE NO : 510 864 4310
1360 SOUTH LOOP RD. SE DECISION MADE: 29-MAR-12
ALAMEDA CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGER II ANGIOGRAPHIC CATHETERS
BOSTON SCIENTIFIC CORP. 510(k) NO: K120893(SPECIAL)
ATTN: ANNE V ROSSI PHONE NO : 763 255 0681
ONE SCIMED PLACE SE DECISION MADE: 29-MAR-12
MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCOLADE II HIP STEM
HOWMEDICA OSTEONICS 510(k) NO: K120578(SPECIAL)
ATTN: VALERIE GIAMBANCO PHONE NO :
325 CORPORATE DRIVE SE DECISION MADE: 29-MAR-12
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
BIO-RAD LABORATORIES 510(k) NO: K103834(TRADITIONAL)
ATTN: JUANG WANG PHONE NO : 510 741 4609
BIOPLEX 2200 DIVISION 5500 EAST SESE DECISION MADE: 30-MAR-12
BENICIA CA 94510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS
ANGIODYNAMICS, INC. 510(k) NO: K112452(SPECIAL)
ATTN: TERI JUCKETT PHONE NO : 518 795 1142
14 PLAZA DRIVE SE DECISION MADE: 30-MAR-12
LATHAM NY 12110 510(k) STATEMENT
DEVICE: URETRON MODEL URT
MED-SONICS CORP 510(k) NO: K111058(ABBREVIATED)
ATTN: WILLIAM A STOLL PHONE NO : 814 899 6500
5451 MERWIN LANE, SUITE 203 SE DECISION MADE: 30-MAR-12
ERIE PA 16510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPIRATORY HUMIDIFER
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K110019(TRADITIONAL)
ATTN: ADELE BINDON PHONE NO : 649 574 0100
15 MAURICE PAYKEL PLACE P.O. BOX 1SE DECISION MADE: 30-MAR-12
AUCKLAND NZ 1741 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATTUNE SLEEP APNEA SYSTEM
APNICURE, INC. 510(k) NO: K111549(TRADITIONAL)
ATTN: CHRIS DANIEL PHONE NO : 650 361 9300
900 CHESAPEAKE DR SE DECISION MADE: 30-MAR-12
REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC
CIBA VISION CORPORATION 510(k) NO: K113168(TRADITIONAL)
ATTN: ALICIA M PLESNARSKI PHONE NO : 678 415 3924
11460 JOHNS CREEK PARKWAY SE DECISION MADE: 30-MAR-12
DULUTH GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLE T NASAL MASK
RESPIRONICS INC. 510(k) NO: K120145(SPECIAL)
ATTN: MICHELLE BRINKER PHONE NO : 724 387 4146
1001 Murry Ridge Ln SE DECISION MADE: 30-MAR-12
MURRYSVILLE PA 15668 510(k) STATEMENT
DEVICE: ETCH-RITE SUPREME
PULPDENT CORPORATION 510(k) NO: K120213(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617 926 6666
80 Oakland St SE DECISION MADE: 30-MAR-12
WATERTOWN MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE ECHOPAC
GE HEALTHCARE 510(k) NO: K120221(SPECIAL)
ATTN: BRYAN BEHN PHONE NO : 414 721 4214
9900 W. INNOVATION DRIVE RP-2138 SE DECISION MADE: 30-MAR-12
WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAZYME CYSTATIN C POC TEST KIT
DIAZYME LABORATORIES 510(k) NO: K111664(TRADITIONAL)
ATTN: ABHIJIT DATTA PHONE NO : 858 455 4762
12889 GREGG COURT SE DECISION MADE: 30-MAR-12
POWAY CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA
BETTINI S.P.A. 510(k) NO: K113431(TRADITIONAL)
ATTN: CLAUDE BERTHOIN PHONE NO : 386 672 2630
110 E. GRANADA BLVD. SUITE 207 SE DECISION MADE: 30-MAR-12
ORMOND BEACH FL 32176 510(k) STATEMENT
DEVICE: KITTYCAT CATHETER, KITTYCAT 2 CATHETER
AVINGER, INC. 510(k) NO: K120273(TRADITIONAL)
ATTN: ALBERT BONISKE PHONE NO : 408 400 0856
755 N. MATHILDA AVENUE STE 100 SE DECISION MADE: 30-MAR-12
SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S
KURARAY MEDICAL INC. 510(k) NO: K120378(TRADITIONAL)
ATTN: MICHIO TAKIGAWA PHONE NO : 813 670 11706
OTE CENTER BLDG. 7F, 1-1-3, OTEMACSE DECISION MADE: 30-MAR-12
CHIYODA-KU JA 100-0004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S
KURARAY MEDICAL INC. 510(k) NO: K120379(TRADITIONAL)
ATTN: MICHIO TAKIGAWA PHONE NO : 813 670 11706
OTE CENTER BLDG. 7F, 1-1-3, OTEMACSE DECISION MADE: 30-MAR-12
CHIYODA-KU JA 100-0004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT
MICROPHAGE, INC. 510(k) NO: K120563(TRADITIONAL)
ATTN: DREW SMITH PHONE NO : 303 652 5049
2400 Trade Centre Ave SE DECISION MADE: 30-MAR-12
Longmont CO 80503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARISURE NEUTRAL VALVE
YUKON MEDICAL, LLC 510(k) NO: K120799(TRADITIONAL)
ATTN: CARL DUPPER PHONE NO : 919 595 8257
4819-400 EMPEROR BLVD SE DECISION MADE: 30-MAR-12
DURHAM NC 27703 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ULTRA BEAUTY
JOHARI DIGITAL HEALTHCARE, LTD. 510(k) NO: K112351(TRADITIONAL)
ATTN: POOJA JOHARI PHONE NO : 858 657 9226
ELECTRONIC HARDWARE TECHNOLOGY PARSE DECISION MADE: 30-MAR-12
BORANADA, JODHPUR, RAJASTHAN IN510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 272
TOTAL WITH SUMMARIES 250
TOTAL WITH STATEMENTS 22
