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U.S. Department of Health and Human Services

Medical Devices

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February 2012 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD February 2012


DEVICE: ONE PERSONAL LUBRICANT (WATER BASED)
ONE                               510(k) NO: K110691(ABBREVIATED)
ATTN: SHARON  PIETILA             PHONE NO : 617 946 2800   
12 CHANNEL STREET                 SE DECISION MADE: 01-FEB-12
BOSTON MA 02210                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUICKSCREEN COCAINE 150 SCREENING TEST
PHAMATECH INC.                    510(k) NO: K103295(TRADITIONAL)
ATTN: CARL  MONGIOVI              PHONE NO : 858 643 5555   
10151 BARNES CANYON RD            SE DECISION MADE: 01-FEB-12
SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIPAP A 30 VENTILATORY SUPPORT SYSTEM
RESPIRONICS, INC.                 510(k) NO: K113053(ABBREVIATED)

ATTN: ELAINE LARKIN PHONE NO : 724 387 5350 1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 01-FEB-12 MONROEVILLE PA 15146 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASS LP SPINAL MEDICREA INTERNATIONAL 510(k) NO: K112736(TRADITIONAL) ATTN: J D WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD SE DECISION MADE: 01-FEB-12 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KLASSIC KNEE SYSTEM TOTAL JOINT ORTHOPEDICS, INC. 510(k) NO: K112906(TRADITIONAL) ATTN: HEATHER LAKE PHONE NO : 408 400 0856 755 N. MATHILDA AVENUE SE DECISION MADE: 01-FEB-12 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT MONITOR EDAN INSTRUMENTS, INC. 510(k) NO: K113623(TRADITIONAL)
ATTN: RANDY JIANG PHONE NO : 867 552 6899197 EQUIPMENTS PARK, NANHAI RD 1019 NOSE DECISION MADE: 01-FEB-12 SHENZHEN CH 518067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT GOLD STANDARD DIAGNOSTICS 510(k) NO: K110899(TRADITIONAL) ATTN: NAPOLEON MONCE PHONE NO : 530 759 8000 2851 SPAFFORD SE DECISION MADE: 01-FEB-12 Davis CA 95618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPSMEDICAL SPORVIEW STEAM BI SPS MEDICAL SUPPLY CORP. 510(k) NO: K111515(TRADITIONAL) ATTN: GARY J SOCOLA PHONE NO : 585 359 0130 6789 WEST HENRIETTA RD. SE DECISION MADE: 01-FEB-12 RUSH NY 14543 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES USS CONNECTORS SYNTHES SPINE 510(k) NO: K113149(TRADITIONAL)
ATTN: HEATHER GUERIN PHONE NO : 610 719 5432 1302 WRIGHTS LN EAST SE DECISION MADE: 01-FEB-12 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAVANNAH TECHNOLOGIES SPINAL SYSTEM SAVANNAH TECHNOLOGIES LLC 510(k) NO: K113755(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD. SE DECISION MADE: 01-FEB-12 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K112074(TRADITIONAL) ATTN: JAY MANSOUR PHONE NO : 678 908 8180 845 ARONSON LAKE COURT SE DECISION MADE: 01-FEB-12 ROSWELL GA 30075 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRUNO ELAN STAIRWAY ELEVATOR BRUNO INDEPENDENT LIVING AIDS, INC510(k) NO: K113308(SPECIAL)
ATTN: TERRENCE O'BRIEN PHONE NO : 262 953 5315 1780 EXECUTIVE DR. SE DECISION MADE: 01-FEB-12 OCONOMOWOC WI 53066 510(k) STATEMENT DEVICE: HAPTITE COATING IMPLANT SYSTEM DENTIS CO., LTD. 510(k) NO: K111364(TRADITIONAL) ATTN: APRIL LEE PHONE NO : 714 525 0114 325 N. PUENTE STREET UNIT B SE DECISION MADE: 01-FEB-12 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREEMIE (R) DAO HEALTH 510(k) NO: K111411(TRADITIONAL) ATTN: DAN GARBEZ PHONE NO : 916 339 7388 2526 Capitol Avenue SE DECISION MADE: 01-FEB-12 Sacramento CA 95816 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONNEXALL SUITE OF SOFTWARE PRODUCTS CONNEXALL USA, INC. 510(k) NO: K112650(TRADITIONAL) ATTN: THOMAS KROENKE PHONE NO : 303 956 4232 PO BOX 3018 SE DECISION MADE: 01-FEB-12 NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) ANGIOTECH 510(k) NO: K113744(TRADITIONAL)
ATTN: KIRSTEN STOWELL PHONE NO : 610 404 3367 100 DENNIS DRIVE SE DECISION MADE: 01-FEB-12 READING PA 19606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT GREATBATCH MEDICAL 510(k) NO: K110051(TRADITIONAL) ATTN: SARA BAKKER PHONE NO : 763 951 8181 2300 BERKSHIRE LANE NORTH SE DECISION MADE: 02-FEB-12 MINNEAPOLIS MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINI-MEDIC ATHENA GTX 510(k) NO: K113165(TRADITIONAL)
ATTN: SEAN MAHONEY PHONE NO : 515 288 3360 3620 SW 61ST STREET SUITE 395 SE DECISION MADE: 02-FEB-12 DES MOINES IA 50321 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM HARTALEGA SND. BHD. 510(k) NO: K112976(TRADITIONAL) ATTN: NURUL A KONG PHONE NO : 603 328 03888 NO. 7, KAWASAN PERUSAHAAN SURIA SE DECISION MADE: 02-FEB-12 BESTARI JAYA MY 45600 510(k) STATEMENT DEVICE: HERO GRAFT HEMOSPHERE INC 510(k) NO: K120006(SPECIAL)
ATTN: LAURIE LYNCH PHONE NO : 952 582 6909 6545 CITY WEST PARKWAY SE DECISION MADE: 02-FEB-12 EDEN PRAIRIE MN 55344 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM FRESENIUS MEDICAL CARE, NORTH AMER510(k) NO: K120017(SPECIAL)
ATTN: DENISE OPPERMANN PHONE NO : 781 699 4479 920 WINTER STREET SE DECISION MADE: 02-FEB-12 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APC FLASH-FREE ADHESIVE 3M UNITEK CORPORATION 510(k) NO: K113197(TRADITIONAL)
ATTN: ROBERT WANG PHONE NO : 626 574 4997 2724 SOUTH PECK RD. SE DECISION MADE: 02-FEB-12 MONROVIA CA 91016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CMAP PRO MEDICAL TECHNOLOGIES, INC. 510(k) NO: K113074(TRADITIONAL)
ATTN: ANGELA MORRIS PHONE NO : 505 604 2864 5901-J WYOMING NE, SUITE 125 SE DECISION MADE: 02-FEB-12 ALBUQUERQUE NM 87106 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: IDS-ISYS INTACT PTH IMMUNODIAGNOSTIC SYSTEMS LTD. 510(k) NO: K103325(TRADITIONAL) ATTN: MICK FENTON PHONE NO : 44 191 5190660 10 DIDCOT WAY, BOLDEN BUSINESS PARSE DECISION MADE: 03-FEB-12 BOLDON, TYNE & WEAR UK NE35 9PD510(k) STATEMENT DEVICE: BLUE PAPOOSE MODEL SBL60 PHYSICIAN ENGINEERED PRODUCTS, INC510(k) NO: K110550(TRADITIONAL) ATTN: ROBERT ROSE PHONE NO : 207 935 1256 103 SMITH ST. SE DECISION MADE: 03-FEB-12 FRYEBURG ME 04037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVEX CX, AND AVEX CXI CERAMIC BRACKETS OPAL ORTHODONTICS BY ULTRADENT PRO510(k) NO: K113334(TRADITIONAL)
ATTN: DIANE ROGERS PHONE NO : 801 553 4491 10200 SOUTH 505 WEST SE DECISION MADE: 03-FEB-12 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTOUR HEALER CONTOUR HEALER, LLC 510(k) NO: K112099(TRADITIONAL) ATTN: ALLEN HARDIN WHITE PHONE NO : 757 288 6671 1117 DITCHLEY ROAD SE DECISION MADE: 03-FEB-12 VIRGINIA BEACH VA 23451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONSERVE THIN SHELL WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K113322(SPECIAL)
ATTN: MATT PAUL PHONE NO : 901 867 4350 5677 AIRLINE RD. SE DECISION MADE: 03-FEB-12 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORAL SPINAL SYSTEM THEKEN SPINE, LLC 510(k) NO: K120047(SPECIAL)
ATTN: DALE DAVISON PHONE NO : 330 239 7709 1153 Medina Rd. SE DECISION MADE: 03-FEB-12 Medina OH 44256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANTARAY CATHETER BRIDGEPOINT MEDICAL 510(k) NO: K120129(SPECIAL)
ATTN: JILL MUNSINGER PHONE NO : 763 225 8500 13355 10TH AVE N, SUITE #110 SE DECISION MADE: 03-FEB-12 PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE CHISON MEDICAL IMAGING CO., LTD. 510(k) NO: K113359(TRADITIONAL)
ATTN: BOB LEIKER PHONE NO : 925 556 1302 7263 CRONIN CIRCLE SE DECISION MADE: 03-FEB-12 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIEZOTOME SOLO SATELEC - ACTEON, INC. 510(k) NO: K112188(TRADITIONAL) ATTN: RICK ROSATI PHONE NO : 800 289 6367 124 GAITHER DR., SUITE 140 SE DECISION MADE: 03-FEB-12 MOUNT LAUREL NJ 08054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD PLAYTEX MANUFACTURING INC. 510(k) NO: K111684(TRADITIONAL) ATTN: PUSHPA RAO PHONE NO : 201 785 8070 75 COMMERCE DRIVE SE DECISION MADE: 03-FEB-12 ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS TERATECH CORP. 510(k) NO: K112953(TRADITIONAL) ATTN: PHONE NO : 77-79 TERRACE HALL AVE. SE DECISION MADE: 03-FEB-12 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: S-MINI IMPLANT SYSTEM NEOBIOTECH CO., LTD. 510(k) NO: K112540(TRADITIONAL) ATTN: APRIL LEE PHONE NO : 714 525 0114 325 N PUENTE ST. UNIT B SE DECISION MADE: 03-FEB-12 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS) CONFORMIS, INC. 510(k) NO: K120068(TRADITIONAL)
ATTN: AMITA SHAH PHONE NO : 781 345 9164 11 North Ave SE DECISION MADE: 03-FEB-12 Burlington MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REST ASSURED GENERATION III DENTAL PROTECTOR RANIR LLC 510(k) NO: K120103(SPECIAL)
ATTN: GERARD J PRUD'HOMME PHONE NO : 202 637 5735 555 THIRTEENTH STREET, NW SE DECISION MADE: 03-FEB-12 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET SOLANA SURGICAL LLC 510(k) NO: K113752(TRADITIONAL)
ATTN: LOUISE FOCHT PHONE NO : 901 818 1860 6363 POPLAR AVE SUITE 434 SE DECISION MADE: 06-FEB-12 MEMPHIS TN 38119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET SOLANA SURGICAL LLC 510(k) NO: K120029(TRADITIONAL)
ATTN: LOUISE FOCHT PHONE NO : 901 818 1860 6363 POPLAR AVE SUITE 434 SE DECISION MADE: 06-FEB-12 MEMPHIS TN 38119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE AESCULAP, INC. 510(k) NO: K111959(TRADITIONAL) ATTN: KATHY A RACOSKY PHONE NO : 610 984 9291 3773 CORPORATE PARKWAY SE DECISION MADE: 06-FEB-12 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVIAID ICVI-F,S,B,R DEVICE SMART MEDICAL SYSTEMS, LTD. 510(k) NO: K112106(TRADITIONAL) ATTN: ADVA YOSELZON PHONE NO : 972 974 44321 10 HAYETSIRA STREET SE DECISION MADE: 06-FEB-12 RAANANA IS 43663 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS MAXTER GLOVE MANUFACTURING SDN BHD510(k) NO: K113100(TRADITIONAL)
ATTN: YAP P GEEH PHONE NO : 603 339 29888 LOT 6070, JALAN HAJI ABDUL MANAN, SE DECISION MADE: 06-FEB-12 MERU, KLANG MY 41050 510(k) STATEMENT DEVICE: VASCULAR SONO PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K113196(TRADITIONAL)
ATTN: CHRISTIAN G QUASS PHONE NO : 049 770 4921586 KARL-HALL-STRASSE 1 SE DECISION MADE: 06-FEB-12 GEISINGEN GM 78187 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTUS INFL A/B RG RT-PCR KIT QIAGEN, GMBH 510(k) NO: K113323(TRADITIONAL)
ATTN: KIM DAVIS PHONE NO : 301 944 7097 1201 CLOPPER RD SE DECISION MADE: 06-FEB-12 GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT MONITOR EDAN INSTRUMENTS, INC. 510(k) NO: K113653(TRADITIONAL)
ATTN: RANDY JIANG PHONE NO : 867 552 6899197 EQUIPMENTS PARK, NANHAI RD 1019 NOSE DECISION MADE: 06-FEB-12 SHENZHEN CH 518067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIO PATCH IRHYTHM TECHNOLOGIES, INC. 510(k) NO: K113862(SPECIAL)
ATTN: MICHAEL RIGHTER PHONE NO : 415 632 5738 650 Townsend Street Suite 380 SE DECISION MADE: 06-FEB-12 San Francisco CA 94103 510(k) STATEMENT DEVICE: CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM ARTHROSURFACE, INC. 510(k) NO: K113762(TRADITIONAL)
ATTN: DAWN J WILSON PHONE NO : 508 520 3003 28 FORGE PARKWAY SE DECISION MADE: 06-FEB-12 FRANKLIN MA 02038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIMETER INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK USA 510(k) NO: K113642(TRADITIONAL)
ATTN: LAUREN KAMER PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 06-FEB-12 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROTOR-GENE Q MDX QIAGEN, GMBH 510(k) NO: K113319(TRADITIONAL)
ATTN: MELISSA MAHALL PHONE NO : 301 944 7768 1201 CLOPPER RD SE DECISION MADE: 06-FEB-12 GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K111890(TRADITIONAL) ATTN: MEIRU LI PHONE NO : 886 266 258188 3F,5F, NO.127 WUGONG 2ND RD, WUGU SE DECISION MADE: 06-FEB-12 NEW TAIPEI CITY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS CORIN U.S.A. 510(k) NO: K111481(TRADITIONAL) ATTN: LUCINDA GERBER PHONE NO : 813 977 4469 10500 UNIVERSITY CENTER DR., SUITESE DECISION MADE: 06-FEB-12 TAMPA FL 33612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATHWAY AVID CUSTOM SPINE, INC. 510(k) NO: K111726(TRADITIONAL) ATTN: DAVID DRUMFIELD PHONE NO : 973 265 5043 1140 PARSIPPANY BLVD. SUITE 201 SE DECISION MADE: 06-FEB-12 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUILEX FLUID CONTROL SYSTEM H112 W.O.M. WORLD OF MEDICINE AG 510(k) NO: K112642(TRADITIONAL) ATTN: SUSANNE RAAB PHONE NO : 617 547 0628 1480 CAMBRIDGE STREET SE DECISION MADE: 06-FEB-12 CAMBRIDGE MA 02139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE ASAHI INTECC CO., LTD. 510(k) NO: K113716(TRADITIONAL)
ATTN: YOSHI TERAI PHONE NO : 949 756 8252 2500 RED HILL SUITE 210 SE DECISION MADE: 06-FEB-12 SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER SKELETAL KINETICS, LLC 510(k) NO: K112383(TRADITIONAL) ATTN: CHRISTINE KUO PHONE NO : 408 350 5842 10201 BUBB RD. SE DECISION MADE: 07-FEB-12 CUPERTINO CA 95014 4167 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT CSA MEDICAL, INC. 510(k) NO: K113021(TRADITIONAL)
ATTN: COLLEEN KISTLER PHONE NO : 443 524 9688 1101 E 33rd Street THIRD FLOOR, STSE DECISION MADE: 07-FEB-12 BALTIMORE MD 21218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS SAFE SECURE PACKAGING CO., LTD 510(k) NO: K112591(TRADITIONAL) ATTN: GARFIELD WANG PHONE NO : 867 552 7040468 CHENGGUANG INDUSTRIAL PARK, NO.4 KSE DECISION MADE: 07-FEB-12 SHENZHEN, GUANGDON CH 5181100 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ORTHO-1(NOT FINALIZED) BISCO, INC. 510(k) NO: K113401(TRADITIONAL)
ATTN: MICHELLE SCHILTZ-TAING PHONE NO : 847 534 6146 1100 WEST IRVING PARK RD. SE DECISION MADE: 07-FEB-12 Schaumburg IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TLINK DATA MANAGEMENT SYSTEM (DMS) TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K113214(TRADITIONAL)
ATTN: REBECCA ANDERSEN PHONE NO : 734 741 6113 6200 JACKSON RD. SE DECISION MADE: 07-FEB-12 ANN ARBOR MI 48103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS ORTHO SOLUTIONS LIMITED 510(k) NO: K111678(TRADITIONAL) ATTN: AL LIPPINCOTT PHONE NO : 952 492 5858 3150 E. 200TH STREET SE DECISION MADE: 07-FEB-12 PRIOR LAKE MN 55372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICAL IMAGE PROCESSING UNIT HUMANRAY CO,LTD 510(k) NO: K113360(SPECIAL)
ATTN: DAVE KIM PHONE NO : 713 467 2607 12946 KIMBERLEY LN SE DECISION MADE: 07-FEB-12 HOUSTON TX 77079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROPHY-MATE NEO NAKANISHI, INC. 510(k) NO: K112673(TRADITIONAL) ATTN: DIANE RUTHERFORD PHONE NO : 972 480 9554 1201 RICHARDSON DRIVE SUITE 280 SE DECISION MADE: 07-FEB-12 RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Z FLEX-270TM STEERABLE SHEATH GREATBATCH MEDICAL 510(k) NO: K112541(TRADITIONAL) ATTN: SARA BAKKER PHONE NO : 763 951 8151 2300 BERKSHIRE LANE NORTH SE DECISION MADE: 07-FEB-12 MINNEAPOLIS MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K103726(TRADITIONAL) ATTN: STEPHANIE SHEESLEY PHONE NO : 717 840 2774 589 DAVIES DRIVE SE DECISION MADE: 08-FEB-12 YORK PA 17402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WINGMAN EXTENDABLE TIP SUPPORT CATHETER REFLOW MEDICAL 510(k) NO: K120178(SPECIAL)
ATTN: REBECCA K PINE PHONE NO : 760 809 5178 1003 Calle Sombra SE DECISION MADE: 08-FEB-12 San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN) SYNTHES USA 510(k) NO: K120083(TRADITIONAL)
ATTN: THOMAS N SHEA PHONE NO : 610 719 6809 1301 GOSHEN PKWY SE DECISION MADE: 08-FEB-12 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOSLENDERIZER ORTHOMATICS, INC. 510(k) NO: K111249(TRADITIONAL) ATTN: PAUL ROCKE PHONE NO : 303 730 7002 200 WEST COUNTY LINE ROAD #340 SE DECISION MADE: 08-FEB-12 HIGHLANDS RANCH CO 80129 510(k) STATEMENT DEVICE: CLEARFLASH AC2100 COSMETIC SYSTEM CLEARFLASH TECHNOLOGIES, INC. 510(k) NO: K111937(TRADITIONAL) ATTN: JOSEPH NEEV PHONE NO : 949 295 6594 2706 S. LA PAZ RD. #108 SE DECISION MADE: 08-FEB-12 ALISO VIEJO CA 92656 3041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM DELBIO INCORPORATION 510(k) NO: K113343(SPECIAL)
ATTN: NICKY PAN PHONE NO : 886 335 96268 3F, NO. 252, SHANGYING ROAD GUISHASE DECISION MADE: 08-FEB-12 TAOYUAN COUNTY TW 33341 510(k) STATEMENT DEVICE: VERACIA SA SHOFU DENTAL CORPORATION 510(k) NO: K113426(TRADITIONAL)
ATTN: DAVID P MORAIS PHONE NO : 760 736 3277 1225 STONE DRIVE SE DECISION MADE: 08-FEB-12 SAN MARCOS CA 92078 510(k) STATEMENT DEVICE: DEPUY PULSE THORACOLUMBAR SCREW SYSTEM MEDOS INTERNATIONAL SARL 510(k) NO: K113396(TRADITIONAL)
ATTN: EUGENE BANG PHONE NO : 508 977 3966 325 PARAMOUNT DRIVE SE DECISION MADE: 08-FEB-12 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IM BAND SYNEXMED (SHENZHEN) COMPANY LIMITE510(k) NO: K113600(TRADITIONAL)
ATTN: ERIC CHIEN PHONE NO : 867 558 380375 B-11/F,ZTY Buliding,TaoHuaRd, FutiSE DECISION MADE: 08-FEB-12 SHENZHEN, GUANGDONG CH 518038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: YOMURA SAFETY I.V. CATHETER YOMURA TECHNOLOGIES INC. 510(k) NO: K112542(TRADITIONAL) ATTN: SHERRY LIN PHONE NO : 886 286 013839 NO. 2-3, KUNG 8TH ROAD SECOND INDUSE DECISION MADE: 08-FEB-12 NEW TAIPEI CITY TW 244 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPLGRAY DOSLSOFT SA 510(k) NO: K112723(TRADITIONAL) ATTN: ROBERT J MORTON PHONE NO : 925 787 2421 1244 FAIRWAY VALLEY COURT SE DECISION MADE: 08-FEB-12 LINCOLN CA 95648 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PUREIMAGE ULTRASOUND TRANSMISSION GEL MEDLINE 510(k) NO: K120156(TRADITIONAL)
ATTN: MATT CLAUSEN PHONE NO : 847 643 4785 ONE MEDLINE PLACE SE DECISION MADE: 08-FEB-12 MUNDLELEIN IL 60060 510(k) STATEMENT DEVICE: FLEXI-Q DV AND DVR AUTO-INJECTORS ELCAM MEDICAL A.C.A.L. 510(k) NO: K111467(TRADITIONAL) ATTN: SHAY SHAHAM PHONE NO : 972 469 88120 KIBBUTZ BAR-AM SE DECISION MADE: 09-FEB-12 D.N. MEROM HAGALIL IS 13860 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HPR EMOLLIENT FOAM PRUGEN IP HOLDINGS, INC 510(k) NO: K113772(TRADITIONAL)
ATTN: SEAN LONERGAN PHONE NO : 480 585 0127 8714 E. VISTA BONITA DR. SE DECISION MADE: 09-FEB-12 SCOTTSDALE AZ 85255 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HPR PLUS EMOLLIENT FOAM PRUGEN IP HOLDINGS, INC 510(k) NO: K113774(TRADITIONAL)
ATTN: SEAN LONERGAN PHONE NO : 480 585 0127 8714 E. VISTA BONITA DR. SE DECISION MADE: 09-FEB-12 SCOTTSDALE AZ 85255 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE DYNATRONICS CORP. 510(k) NO: K113250(TRADITIONAL)
ATTN: DOUGLAS SAMPSON PHONE NO : 801 567 7000 7030 PARK CENTRE DR. SE DECISION MADE: 09-FEB-12 Salt Lake City UT 84121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 SHANGHAI 3F ELECTRONICS CO LTD 510(k) NO: K113183(ABBREVIATED)
ATTN: CHARILIE MACK PHONE NO : 931 625 4938 77325 JOYCE WAY SE DECISION MADE: 09-FEB-12 ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HAMILTON-TC1 HAMILTON MEDICAL AG 510(k) NO: K112006(TRADITIONAL) ATTN: RALPH AGUILA PHONE NO : 491 714 017192 VIA CRUSCH 8 SE DECISION MADE: 09-FEB-12 BONADUZ SZ 7402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRA WOUND MATRIX (THIN) INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K113104(TRADITIONAL)
ATTN: STEPHEN H BEIER PHONE NO : 609 939 5436 311 ENTERPRISE DR. SE DECISION MADE: 09-FEB-12 PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON VOYAGER SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K113529(TRADITIONAL)
ATTN: MIKE SCOTT PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 09-FEB-12 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFX INTRODUCER SYSTEM ENDOLOGIX, INC. 510(k) NO: K120212(SPECIAL)
ATTN: JANET M FAULS PHONE NO : 949 595 7203 11 STUDEBAKER SE DECISION MADE: 09-FEB-12 IRVINE CA 92610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STIMULATION/DISSECTION INSTRUMENTS NUVASIVE, INCORPORATED 510(k) NO: K112709(TRADITIONAL) ATTN: ELIAS KETCHUM PHONE NO : 858 320 4588 7475 LUSK BOULEVARD SE DECISION MADE: 09-FEB-12 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PILLAR PALATAL IMPLANT SYSTEM MEDTRONIC XOMED, INC. 510(k) NO: K110623(TRADITIONAL) ATTN: ROZANNE PACIEJ PHONE NO : 904 332 8233 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 10-FEB-12 JACKSONVILLE FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTRICARE DEVON MEDICAL PRODUCTS, INC. 510(k) NO: K110078(TRADITIONAL) ATTN: RUTH WU PHONE NO : 800 251 7488 1100 FIRST AVENUE, SUITE 100 SE DECISION MADE: 10-FEB-12 KING OF PRUSSIA PA 19406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MESO WOUND MATRIX KENSEY NASH CORPORATION 510(k) NO: K112888(TRADITIONAL) ATTN: LORI A BURNS PHONE NO : 484 713 2100 735 PENNSYLVANIA DRIVE SE DECISION MADE: 10-FEB-12 EXTON PA 19341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EIGR SURGICAL ILLUMINATION SYSTEM INVUITY, INC. 510(k) NO: K113697(SPECIAL)
ATTN: THERESA BRANDNER-ALLEN PHONE NO : 415 655 2160 39 STILLMAN STREET SE DECISION MADE: 10-FEB-12 SAN FRANCISO CA 94107 510(k) STATEMENT DEVICE: SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) SPINE VIEW, INC. 510(k) NO: K113362(SPECIAL)
ATTN: SEVRINA CIUCCI PHONE NO : 510 743 5090 48810 Kato Rd. Suite 100E SE DECISION MADE: 10-FEB-12 Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KINGYIELD WRIST BLOOD PRESSURE MONITOR SHENZHEN KINGYIELD TECHNOLOGY CO.,510(k) NO: K112042(TRADITIONAL) ATTN: DACHENG GONG PHONE NO : 86 755 27326734 FUHAI RD, RUYONG TOWN BAOAN DIST. SE DECISION MADE: 10-FEB-12 SHENZHEN, GUANGDONG CH 518103 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION BESTGEN BIOTECH CORP. 510(k) NO: K103044(TRADITIONAL) ATTN: STEVEN SHEN PHONE NO : 886 282 272188 7F, NO 186, JIAN-YI ROAD SE DECISION MADE: 10-FEB-12 JUNG-HE, TAIPEI COUNTY TW 235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSE MSK S 8CH 1.5T INVIVO CORPORATION 510(k) NO: K120122(SPECIAL)
ATTN: LISA SIMPSON PHONE NO : 325 336 0010 3545 SW 47TH AVE. SE DECISION MADE: 10-FEB-12 GAINESVILLE FL 32608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE BIOMERIEUX, INC. 510(k) NO: K113305(TRADITIONAL)
ATTN: JOLYN TENLLADO PHONE NO : 314 731 8386 595 ANGLUM RD. SE DECISION MADE: 10-FEB-12 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REGIUS SIGMA2 KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K120131(SPECIAL)
ATTN: RUSSELL MUNVES PHONE NO : 212 497 8208 140 EAST 45TH ST., 25TH FLOOR TWO SE DECISION MADE: 10-FEB-12 NEW YORK NY 10017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: L-SER KO LAMP YA-MAN LTD 510(k) NO: K112016(TRADITIONAL) ATTN: NELSON MARQUINA PHONE NO : 804 366 3110 9210 FOREST HILL AVE STE B-3 SE DECISION MADE: 10-FEB-12 RICHMOND VA 23235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A PANASONIC HEALTHCARE CO., LTD. 510(k) NO: K113612(TRADITIONAL)
ATTN: RAM BEDI PHONE NO : 425 985 8670 2425 SQUAK MOUNTAIN LOOP SW SE DECISION MADE: 10-FEB-12 ISSAQUAH WA 98027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOTOUCH BREASTSCAN UE LIFESCIENCES, INC. 510(k) NO: K113259(TRADITIONAL)
ATTN: MIHIR SHAH PHONE NO : 267 342 3303 4435 LOBELLA COURT SE DECISION MADE: 10-FEB-12 CHESTER SPRINGS PA 19425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) SALTER LABS, ARVIN FACILITY 510(k) NO: K113542(TRADITIONAL)
ATTN: MICHAEL SHOUP PHONE NO : 661 854 3166 100 Sycamore Rd SE DECISION MADE: 10-FEB-12 ARVIN CA 93203 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CRE DITATATION BALLON BOSTON SCIENTIFIC CORPORATION 510(k) NO: K112994(TRADITIONAL) ATTN: JANIS TARANTO PHONE NO : 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 10-FEB-12 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMID STAPLER SAFESTICH MEDICAL, LLC 510(k) NO: K120268(SPECIAL)
ATTN: ALINA CARABALLO PHONE NO : 305 575 4600 4400 BISCAYNE BLVD. SUITE 670 SE DECISION MADE: 10-FEB-12 MIAMI FL 33137 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL DENTSPLY INTERNATIONAL, INC. 510(k) NO: K113406(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717 849 4229 221 W. PHILADELPHIA ST., SE 60 SUSSE DECISION MADE: 13-FEB-12 YORK PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER, HANGZHOU BEVER MEDICAL DEVICES CO.510(k) NO: K111405(TRADITIONAL) ATTN: ALLYSON ZHOU PHONE NO : 86 571 88616630 NO. 8-1, LONGQUAN ROAD CANGQIAN TOSE DECISION MADE: 13-FEB-12 HANGZHOU, ZHEJIANG CH 311121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COFLEX-F PARADIGM SPINE, LLC 510(k) NO: K112595(TRADITIONAL) ATTN: MARC VISCOGLIOSI PHONE NO : 212 583 9700 505 PARK AVENUE, 14TH FLOOR SE DECISION MADE: 13-FEB-12 NEW YORK NY 10022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYFUSE - NEUROBONE ATPAC MEDICAL LLC 510(k) NO: K111018(TRADITIONAL) ATTN: GARY MALINOWSKI PHONE NO : 805 453 3353 848 N RAINBOW BLVD SE DECISION MADE: 14-FEB-12 LAS VEGAS NV 89107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INJEKT CYSTO FLEXIBLE INJECTION NEEDLE COOK IRELAND LTD 510(k) NO: K113634(SPECIAL)
ATTN: LAURA GUINANE PHONE NO : 353 613 34440 O'HALLORAN ROAD NATIONAL TECHNOLOGSE DECISION MADE: 14-FEB-12 LIMERICK EI EL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) MERIDIAN AG 510(k) NO: K113390(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720 962 5412 5401 S. COTTONWOOD CT. SE DECISION MADE: 14-FEB-12 GREENWOOD VILLAGE CO 80121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM GE MEDICAL SYSTEMS SCS 510(k) NO: K113403(TRADITIONAL)
ATTN: MICHEL GENUER PHONE NO : 33 130 704741 283 RUE DE LA MINIERE SE DECISION MADE: 14-FEB-12 BUC FR 78530 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR PHILIPS MEDICAL SYSTEMS 510(k) NO: K120132(SPECIAL)
ATTN: MARY KRUITWAGEN PHONE NO : 978 659 4932 3000 MINUTEMAN RD. SE DECISION MADE: 14-FEB-12 ANDOVER MA 01810 1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VICTORY GUIDEWIRE (32 MODELS) BRIVANT, LTD. 510(k) NO: K120137(SPECIAL)
ATTN: KENNETH WALSH PHONE NO : 353 91 385037 PARKMORE WEST BUSINESS PARK SE DECISION MADE: 14-FEB-12 GALWAY EI EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CADENS (TM) COLON DOG MICROSYSTEMS, INC. 510(k) NO: K111758(TRADITIONAL) ATTN: FLORENT CHANDELIER PHONE NO : 450 956 3456 116 PRINCIPALE SUITE 200 SE DECISION MADE: 14-FEB-12 GRANBY, QUEBEC CA J2G 2V2 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT COLOPLAST A/S 510(k) NO: K113496(TRADITIONAL)
ATTN: JANELL COLLEY PHONE NO : 612 287 4211 1601 WEST RIVER RD NORTH SE DECISION MADE: 14-FEB-12 MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITAL SIGNS MONITOR EDAN INSTRUMENTS INC 510(k) NO: K120144(SPECIAL)
ATTN: RANDY JIANG PHONE NO : 867 552 6856469 3/F-B, NANSHAN MEDICAL EQUIPMENTS SE DECISION MADE: 14-FEB-12 SHENZHEN CH 518067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... IMMUNODIAGNOSTIC SYSTEMS LTD. 510(k) NO: K111938(ABBREVIATED) ATTN: MICK FENTON PHONE NO : 44 191 5190660 10 DIDCOT WAY, BOLDEN BUSINESS PARSE DECISION MADE: 14-FEB-12 BOLDON, TYNE & WEAR UK NE35 9PD510(k) STATEMENT DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR FULL SYNERGY MEDICAL PRODUCTS INC 510(k) NO: K113710(ABBREVIATED)
ATTN: ELIZABETH DENG PHONE NO : 909 465 9188 5748 EAGLEWOOD PLACE SE DECISION MADE: 14-FEB-12 RANCHO CUCAMONGA CA 91739 510(k) STATEMENT DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR FULL SYNERGY MEDICAL PRODUCTS INC 510(k) NO: K113722(TRADITIONAL)
ATTN: ELIZABETH DENG PHONE NO : 909 465 9188 5748 EAGLEWOOD PLACE SE DECISION MADE: 14-FEB-12 RANCHO CUCAMONGA CA 91739 510(k) STATEMENT DEVICE: ESOPHAGEAL TTS STENT TAEWOONG MEDICAL CO., LTD 510(k) NO: K113551(TRADITIONAL)
ATTN: STEPHEN RHODES PHONE NO : 301 579 3700 400 N. WASHINGTON ST SUITE 100 SE DECISION MADE: 14-FEB-12 ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS INSTRUMENT TRAY OLYMPUS WINTER & IBE GMBH 510(k) NO: K110748(TRADITIONAL) ATTN: STACY KLUESNER PHONE NO : 484 986 5405 3500 CORPORATE PKWAY SE DECISION MADE: 15-FEB-12 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 NAKANISHI, INC. 510(k) NO: K110278(TRADITIONAL) ATTN: DIANE RUTHERFORD PHONE NO : 972 480 9554 1201 RICHARDSON DRIVE SUITE 280 SE DECISION MADE: 15-FEB-12 RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL HOWMEDICA OSTEONICS CORP. 510(k) NO: K113409(TRADITIONAL)
ATTN: JUMA HOSHINO PHONE NO : 201 831 5992 325 CORPORATE DR SE DECISION MADE: 15-FEB-12 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. 510(k) NO: K113378(TRADITIONAL)
ATTN: AMITA S SHAH PHONE NO : 781 345 9164 11 North Ave SE DECISION MADE: 15-FEB-12 Burlington MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEPHAFLEX LIGHT MESH TEPHA, INC. 510(k) NO: K113721(TRADITIONAL)
ATTN: MARY P LEGRAW PHONE NO : 781 357 1700 99 HAYDEN AVENUE, SUITE 360 SE DECISION MADE: 15-FEB-12 LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEPHAFLEX MESH TEPHA, INC. 510(k) NO: K113723(TRADITIONAL)
ATTN: MARY P LEGRAW PHONE NO : 781 357 1700 99 HAYDEN, SUITE 360 SE DECISION MADE: 15-FEB-12 LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTROPULSE-COSMETIC PAIN RELIEF TECHNOLOGIES 510(k) NO: K113724(TRADITIONAL)
ATTN: KENDALL GORHAM PHONE NO : 480 231 0975 15048 SW CAPSTONE CT. SE DECISION MADE: 15-FEB-12 BEAVERTON OR 97007 510(k) STATEMENT DEVICE: FOCUS SPINAL SYSTEM L&K BIOMED CO., LTD 510(k) NO: K120140(SPECIAL)
ATTN: HEE KYEONG JOO PHONE NO : 822 262 41475 #1104, ACE HIGH-END TOWER 3 CHA, 3SE DECISION MADE: 15-FEB-12 GEUMCHEON-GU, SEOUL KS 153-803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EAUM TOTAL KNEE SYSTEM CORENTEC CO., LTD 510(k) NO: K110404(TRADITIONAL) ATTN: KEVIN A THOMAS PHONE NO : 858 792 1235 11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 16-FEB-12 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3DI SHINA SYSTEMS LTD. 510(k) NO: K113442(TRADITIONAL)
ATTN: DAN LAOR PHONE NO : 972 483 46632 6 SIRENI SE DECISION MADE: 16-FEB-12 HAIFA IS 32972 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES PHILIPS MEDICAL SYSTEMS 510(k) NO: K110825(TRADITIONAL) ATTN: PAUL SCHRADER PHONE NO : 978 659 2404 3000 MINUTEMAN ROAD SE DECISION MADE: 16-FEB-12 ANDOVER MA 01810 1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR IMPACT INSTRUMENTATION, INC. 510(k) NO: K111473(TRADITIONAL) ATTN: SUSAN MCNEVIN PHONE NO : 973 882 1212 27 FAIRFIELD PL. SE DECISION MADE: 16-FEB-12 WEST CALDWELL NJ 07006 0508 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVIS EXERA III VIDEO SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K112680(TRADITIONAL) ATTN: STACY ABBATIELLO KLUESNER PHONE NO : 484 896 5405 3500 CORPORATE PARKWAY PO BOX 610 SE DECISION MADE: 16-FEB-12 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAVES WATERS ADVANCED VIABILITY EVALUATION SYSTEM WATERS MEDICAL SYSTEMS, LLC 510(k) NO: K111521(TRADITIONAL) ATTN: ROBERT WARREN PHONE NO : 800 426 9877 2112 15TH ST. N.W., SUITE A SE DECISION MADE: 16-FEB-12 ROCHESTER MN 55901 0716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISIA NEURO MEVIS MEDICAL SOLUTIONS AG 510(k) NO: K113701(TRADITIONAL)
ATTN: THOMAS E TYNES PHONE NO : 262 691 9530 N27 W24075 PAUL COURT SUITE 100 SE DECISION MADE: 16-FEB-12 PEWAUKEE WI 53072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD MAX GBS ASSAY, BD MAX INSTRUMENT BECTON DICKINSON & CO. 510(k) NO: K111860(TRADITIONAL) ATTN: MARY ANNE WILLIAMS PHONE NO : 913 261 9890 7 LOVETON CIR. SE DECISION MADE: 16-FEB-12 BALTIMORE MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURFACE BEACON TRANSPONDERS CALYPSO MEDICAL TECHNOLOGIES INC 510(k) NO: K112841(TRADITIONAL) ATTN: MARCIA PAGE PHONE NO : 206 774 4234 2101 FOURTH AVE SUITE 500 SE DECISION MADE: 16-FEB-12 SEATTLE WA 98121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE BIOMET, INC. 510(k) NO: K120121(SPECIAL)
ATTN: PATRICIA BERES PHONE NO : 574 267 6639 P.O. BOX 587 SE DECISION MADE: 16-FEB-12 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLEURX PLEURAL CATHETER SYSTEMS CAREFUSION 510(k) NO: K112831(TRADITIONAL) ATTN: JOY GREIDANUS PHONE NO : 847 473 7404 1500 WAUKEGAN ROAD SE DECISION MADE: 16-FEB-12 WAUKEGAN IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ICON (TM) MODULAR PEDICLE SCREW SYSTEM ORTHOFIX, INC. 510(k) NO: K111448(TRADITIONAL) ATTN: DARLA CHEW PHONE NO : 214 937 2000 3451 PLANO PARKWAY SE DECISION MADE: 16-FEB-12 LEWISVILLE TX 75056 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STLASE DENTAL PHOTONICS, INC 510(k) NO: K111689(TRADITIONAL) ATTN: MARCY MOORE PHONE NO : 919 363 2432 131 KELEKENT LANE SE DECISION MADE: 16-FEB-12 CARY NC 27518 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM MEDOS INTERNATIONAL SARL 510(k) NO: K113526(SPECIAL)
ATTN: JOCELYN RAPOSO PHONE NO : 508 828 3421 325 PARAMOUNT DRIVE SE DECISION MADE: 16-FEB-12 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KOWA VX-20 KOWA CO. LTD. 510(k) NO: K112330(TRADITIONAL) ATTN: HIROYUKI KOIDE PHONE NO : 81 332 797646 4-14, NIHONBASHI-HONCHO 3-CHOME, CSE DECISION MADE: 16-FEB-12 TOKYO JA 103-8433 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS ABBOTT LABORATORIES 510(k) NO: K111874(TRADITIONAL) ATTN: ARUL STERLIN PHONE NO : 510 864 4310 1360 SOUTH LOOP ROAD SE DECISION MADE: 16-FEB-12 ALAMEDA CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CS IMAGING TROPHY 510(k) NO: K113419(TRADITIONAL)
ATTN: MARIE-PIERRE LABAT-CAMY PHONE NO : 331 648 08500 4 RUE F. PELLOUTIER SE DECISION MADE: 16-FEB-12 CROISSY-BEAUBOURG FR 77435 510(k) STATEMENT DEVICE: CHROMOPHARE F 628 AND F 528 BERCHTOLD GMBH & CO. KG 510(k) NO: K120392(TRADITIONAL)
ATTN: VOLKER HORNSCHEIDT PHONE NO : 490 461 181374 LUDWIGSTALER STR. 25 SE DECISION MADE: 16-FEB-12 TUTTLINGEN GM D-78532 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: 3B WILLOW 3B PRODUCTS, LLC 510(k) NO: K112271(TRADITIONAL) ATTN: ALEX LUCIO PHONE NO : 863 676 5948 1142 N SCENIC HIGHWAY SE DECISION MADE: 16-FEB-12 LAKE WALES FL 33853 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL APOLLO SPINE 510(k) NO: K120143(SPECIAL)
ATTN: MICHELE LUCEY PHONE NO : 603 763 3455 128 BLYE HILL LANDING SE DECISION MADE: 16-FEB-12 NEWBURY NH 03255 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I-PORT ADVANCE INJECTION PORT UNOMEDICAL A/S 510(k) NO: K120337(ABBREVIATED)
ATTN: SOREN MELSTED PHONE NO : 454 816 7000 AAHOLMVEJ 1-3 SE DECISION MADE: 16-FEB-12 OSTED, LEJRE DA 4320 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM SPINEFRONTIER, INC. 510(k) NO: K113518(ABBREVIATED)
ATTN: CHRISTOPHER CHANG PHONE NO : 978 232 3990 500 CUMMINGS CENTER SUITE 3500 SE DECISION MADE: 16-FEB-12 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLOSER TO NATURE ELECTRIC BREAST PUMP MAYBORN GROUP LIMITED 510(k) NO: K113664(TRADITIONAL)
ATTN: NEIL HEWITT PHONE NO : 441 912 501864 DUDLEY LANE CRAMLINGTON SE DECISION MADE: 17-FEB-12 NORTHUMBERLAN UK NE23 TRH 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SIRONA DENTAL CAD/CAM SYSTEM SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K111421(TRADITIONAL) ATTN: FRITZ KOLLE PHONE NO : 496 251 163294 FABRIKSTRASSE 31 SE DECISION MADE: 17-FEB-12 BENSHEIM GM D-64625 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I) LUMINEX MOLECULAR DIAGNOSTICS, INC510(k) NO: K112781(TRADITIONAL) ATTN: LUBNA SYED PHONE NO : 416 593 4323 439 UNIVERSITY AVE. SUITE 900 SE DECISION MADE: 17-FEB-12 TORONTO, ONTARIO CA M5G 1Y8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY ORTHOCON 510(k) NO: K113627(SPECIAL)
ATTN: ROSEMARY HARRY PHONE NO : 914 357 2600 1 BRIDGE STREET SUITE 121 SE DECISION MADE: 17-FEB-12 IRVINGTON NY 10533 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERFREE POLYISOPRENE SURGICAL GLOVES PT. MEDISAFE TECHNOLOGIES 510(k) NO: K112654(TRADITIONAL) ATTN: ANIL TANEJA PHONE NO : 626 130 007134 JL.BATANG KUIS GG.TAMBAK REJO DESASE DECISION MADE: 17-FEB-12 MEDAN, NORTH SUMATERA ID 20362 510(k) STATEMENT DEVICE: VALEO VT-601 SERIES IR THERMOMETER VALEO CORP. 510(k) NO: K111463(TRADITIONAL) ATTN: JENNIFER REICH PHONE NO : 928 863 8140 2904 N. BOLDT DRIVE SE DECISION MADE: 17-FEB-12 FLAGSTAFF AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX KNOTLESS SUTURETAK ANCHOR ARTHREX, INC. 510(k) NO: K120155(SPECIAL)
ATTN: CHRISTINA FLORES PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 17-FEB-12 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER GREINER BIO-ONE NORTH AMERICA, INC510(k) NO: K113505(TRADITIONAL)
ATTN: JUDI SMITH PHONE NO : 410 592 2060 P.O. BOX 103 SE DECISION MADE: 17-FEB-12 BALDWIN MD 21013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NANOBLUTM 500 DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K113206(TRADITIONAL)
ATTN: BRYAN OVERTON PHONE NO : 215 660 2135 3135 QUARRY RD. SE DECISION MADE: 17-FEB-12 TELFORD PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EQUIVITAL HIDALGO LIMITED 510(k) NO: K113054(SPECIAL)
ATTN: EKTA SOOD PHONE NO : 441 954 233430 Unit F Buckinghamway Business ParkSE DECISION MADE: 17-FEB-12 Cambridge GB CB24 4UQ 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM PHILIPS HEALTHCARE 510(k) NO: K120321(TRADITIONAL)
ATTN: ROB BUTLER PHONE NO : 978 659 2785 3000 MINUTEMAN RD SE DECISION MADE: 17-FEB-12 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VITEK 2 STREPTOCOCCUS ERYTHROMYCIN BIOMERIEUX, INC. 510(k) NO: K111976(TRADITIONAL) ATTN: JENNIFER CHIA-HSUAN LIN PHONE NO : 314 731 8639 595 ANGLUM RD. SE DECISION MADE: 17-FEB-12 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TI-BASE ABUTMENT, 1 CONNECT ABUTMENT NT-TRADING GMBH AND CO KG 510(k) NO: K111935(TRADITIONAL) ATTN: WILLIAM GREENROSE PHONE NO : 603 369 3550 220 RIVER ROAD SE DECISION MADE: 17-FEB-12 CLAREMONT NH 03743 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEODESIC EEG MOBILE 100 (GEM 100) BOVARD CONSULTING LLC 510(k) NO: K112353(TRADITIONAL) ATTN: LINDA J BOVARD PHONE NO : 541 345 5431 29611 SIMMONS RD. SE DECISION MADE: 17-FEB-12 EUGENE OR 97405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACU-CUT VERTEBRAL AUGMENTATION SYSTEM ASCENDX SPINE, INC. 510(k) NO: K113452(TRADITIONAL)
ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET STREET, 29TH FLOOR SE DECISION MADE: 17-FEB-12 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET KENTEC MEDICAL, INC. 510(k) NO: K120272(TRADITIONAL)
ATTN: KEITH ROOKS PHONE NO : 17871 FITCH SE DECISION MADE: 17-FEB-12 IRVINE CA 92614 6001 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ACE STAPLER AND CARTRIDGE BAROSENSE, INC 510(k) NO: K120147(SPECIAL)
ATTN: SHEILA STEVENS, PHD PHONE NO : 650 362 6000 250 CHESAPEAKE DRIVE SE DECISION MADE: 17-FEB-12 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM ACUTE INNOVATIONS LLC 510(k) NO: K120163(SPECIAL)
ATTN: MARIAH KNIGHT PHONE NO : 503 686 7200 21421 NW JACOBSON RD. SUITE 700 SE DECISION MADE: 17-FEB-12 HILLSBORO OR 97124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS CINCINNATI SUB-ZERO PRODUCTS, INC.510(k) NO: K120081(TRADITIONAL)
ATTN: STEVEN J BERKE PHONE NO : 513 772 8810 12011 MOSTELLER RD. SE DECISION MADE: 17-FEB-12 CINCINNATI OH 45241 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAGNER CONE PROSTHESIS SYSTEM ZIMMER GMBH 510(k) NO: K113556(SPECIAL)
ATTN: DANIEL J WILLIAM PHONE NO : 574 371 8065 P.O. BOX 708 SE DECISION MADE: 17-FEB-12 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR WENZHOU BOKANG INSTRUMENT CO.,LTD 510(k) NO: K111141(ABBREVIATED) ATTN: JOHNNY CAO PHONE NO : 865 718 6984378 RM 1623, BLOCK B, NO 83 NORTH QUIUSE DECISION MADE: 21-FEB-12 HANGZHOU, ZHIJIANG CH 310016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM STERIS CORPORATION 510(k) NO: K113520(SPECIAL)
ATTN: ROBERT SULLIVAN PHONE NO : 440 354 2600 5960 HEISLEY ROAD SE DECISION MADE: 21-FEB-12 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM MATERIALISE DENTAL NV 510(k) NO: K112679(TRADITIONAL) ATTN: CARL VAN LIERDE PHONE NO : 32 16 396714 TECHNOLOGIELAAN 15 SE DECISION MADE: 22-FEB-12 LEUVEN BE 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) VENTANA MEDICAL SYSTEMS, INC. 510(k) NO: K111755(TRADITIONAL) ATTN: TROY QUANDER PHONE NO : 520 229 4184 1910 E.INNOVATION PARK DR. SE DECISION MADE: 22-FEB-12 TUCSON AZ 85755 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEFORTE NEURO SYSTEM BONE PLATE JEIL MEDICAL CORPORATION 510(k) NO: K112812(SPECIAL) ATTN: PAUL SUMNER PHONE NO : 770 448 7529 5966 EXETER CIRCLE SE DECISION MADE: 22-FEB-12 NORCROSS GA 30071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP INTEGRA BURLINGTON MA, INC. 510(k) NO: K113570(TRADITIONAL)
ATTN: LINDSAY MIGNONE PHONE NO : 609 936 5583 22 TERRY AVE. SE DECISION MADE: 22-FEB-12 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTHEART SHL TELEMEDICINE INTERNATIONAL LTD510(k) NO: K113514(TRADITIONAL)
ATTN: YORAM LEVY PHONE NO : 972 463 88837 31 HAAVODA ST. SE DECISION MADE: 22-FEB-12 BINYAMINA IS 30500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INCONTROL INCONTROL MEDICAL, LLC 510(k) NO: K110179(TRADITIONAL) ATTN: MICHAEL LEIGH PHONE NO : 262 957 6797 12715 FALCON DRIVE SE DECISION MADE: 22-FEB-12 BROOKFIELD WI 53005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RL, UL, SL, EL, AND EPL VERTICAL PLATFORM LIFTS BELLA ELEVATOR, LLC 510(k) NO: K113065(TRADITIONAL)
ATTN: RICK CRANE PHONE NO : 309 689 8090 8915 N. PIONEER RD SE DECISION MADE: 22-FEB-12 PEORIA IL 61615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRA LASER SYSTEM LUTRONIC CORPORATION 510(k) NO: K113588(TRADITIONAL)
ATTN: JHUNG WON VOJIR PHONE NO : 215 205 2219 6 NESHAMINY INTERPLEX, SUITE 207 SE DECISION MADE: 22-FEB-12 TREVOSE PA 19053 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BONETRAP BERNI FARNS INCORPORATED 510(k) NO: K120189(TRADITIONAL)
ATTN: NICOLA BERNI PHONE NO : 352 438 4540 P.O. BOX 139 SE DECISION MADE: 22-FEB-12 FERNANDINA BEACH FL 32035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASPIRE MAX ASPIRATION CATHETER CONTROL MEDICAL TECHNOLOGY, LLC 510(k) NO: K113757(TRADITIONAL)
ATTN: SHAWN P FOJTIK PHONE NO : 435 602 9640 136 HEBER AVENUE, SUITE 101, PO BOSE DECISION MADE: 22-FEB-12 PARK CITY UT 84068 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INVENDO C20 COLONOSCOPY SYSTEM INVENDO MEDICAL GBMH 510(k) NO: K100624(TRADITIONAL) ATTN: OLIVER V RUEPPRECHT PHONE NO : 202 637 5794 PETERHOFSTRAUSSE 3B SE DECISION MADE: 23-FEB-12 KISSING GM 86438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLUESHINE'S GOLD SERIES BLUESHINE SRL 510(k) NO: K110375(TRADITIONAL) ATTN: CHIARA RICCI PHONE NO : 390 041 5055847 VIA G. QUERINI 27 SE DECISION MADE: 23-FEB-12 MESTRE IT 30171 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PILAIRO NASAL PILLOWS MASK FISHER & PAYKEL HEALTHCARE LIMITED510(k) NO: K120027(TRADITIONAL)
ATTN: TINA MASON PHONE NO : 649 574 0100 15 MAURICE PAYKEL PLACE EAST TAMAKSE DECISION MADE: 23-FEB-12 AUCKLAND NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE NAKAMURA DENTAL HANDPIECE MFG. CO.510(k) NO: K113222(TRADITIONAL)
ATTN: SHINICHI NAKAMURA PHONE NO : 813 395 55307 59-2 MINAMI-CHO SE DECISION MADE: 23-FEB-12 ITABASHI-KU, TOKYO JA 173-0027 510(k) STATEMENT DEVICE: KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT TORNIER 510(k) NO: K111970(TRADITIONAL) ATTN: STEPHANIE BERNARD PHONE NO : 330 476 613500 161 RUE LAVOISIER MONTBONNOT SE DECISION MADE: 23-FEB-12 SAINT-ISMIER CEDEX FR 38334 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UPSTREAM SUPPORT CATHETER UPSTREAM PERIPHERAL TECHNOLOGIES 510(k) NO: K112886(TRADITIONAL) ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET STREET 29TH FLOOR SE DECISION MADE: 23-FEB-12 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLLAGEN RIBBON WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K120019(TRADITIONAL)
ATTN: LESLIE FITCH PHONE NO : 901 867 4120 5677 AIRLINE RD. SE DECISION MADE: 23-FEB-12 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIXATE TISSUE BAND ANULEX TECHNOLOGIES, INC 510(k) NO: K113805(TRADITIONAL)
ATTN: RACHEL KENNEDY PHONE NO : 952 224 4034 5600 ROWLAND ROAD, STE 280 SE DECISION MADE: 23-FEB-12 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10 KAT IMPLANTS, LLC 510(k) NO: K112758(TRADITIONAL) ATTN: VITALI BONDAR PHONE NO : 603 427 0084 15 RYE STREET SUITE 115 SE DECISION MADE: 23-FEB-12 PORTSMOUTH NH 03801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROULTRA PIEZO ULTRASONIC SATELEC-ACTEON GROUP 510(k) NO: K113430(TRADITIONAL)
ATTN: RICK ROSATI PHONE NO : 800 289 6367 124 GAITHER DRIVE , SUITE 140 SE DECISION MADE: 23-FEB-12 MT LAUREL NJ 08054 510(k) STATEMENT DEVICE: SUREFIRE GUIDE SHEATH SUREFIRE MEDICAL, INC 510(k) NO: K113737(SPECIAL)
ATTN: MARIO ARBESU PHONE NO : 305 378 2651 12415 SW 136 AVENUE UNIT 3 SE DECISION MADE: 23-FEB-12 MIAMI FL 33186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Q. FREEZE (MOTION VUE2) GE MEDICAL SYSTEMS, LLC 510(k) NO: K113408(TRADITIONAL)
ATTN: DAVID DUERSTELER PHONE NO : 262 312 7029 3000 N GRANDVIEW BLVD. SE DECISION MADE: 24-FEB-12 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOL-M EXCHANGEABLE NEEDLES SOL-MILENNIUM MEDICAL, INC. 510(k) NO: K112777(TRADITIONAL) ATTN: JIM BARLEY PHONE NO : 949 481 5713 33822 MALAGA DRIVE SE DECISION MADE: 24-FEB-12 DANA POINT CA 92629 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONY LMD-2451MT LCD MONITOR SONY ELECTRONICS, INC. 510(k) NO: K113203(TRADITIONAL)
ATTN: CYNTHIA SINCLAIR PHONE NO : 508 643 0434 49 PLAIN STREET SE DECISION MADE: 24-FEB-12 NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JETSTREAM NAVITUS L SYSTEM PATHWAY MEDICAL TECHNOLOGIES, INC.510(k) NO: K120242(SPECIAL)
ATTN: BRIT BAIRD PHONE NO : 425 636 4079 10801 120th Avenue NE SE DECISION MADE: 24-FEB-12 Kirkland WA 98033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS LIMACORPORATE S.P.A. 510(k) NO: K113254(TRADITIONAL)
ATTN: CHERYL HASTINGS PHONE NO : 574 527 4220 P.O. BOX 696 SE DECISION MADE: 24-FEB-12 WINONA LAKE IN 46590 696 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINEAR HIP STEM, SIZE 5 ENCORE MEDICAL, L.P. 510(k) NO: K120241(SPECIAL)
ATTN: TEFFANY HUTTO PHONE NO : 512 832 9500 9800 METRIC BLVD. SE DECISION MADE: 24-FEB-12 AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM WELLDOC, INC 510(k) NO: K120314(SPECIAL)
ATTN: LAUREN BRONICH-HALL PHONE NO : 443 692 3100 1501 SAINT PAUL STREET SUITE 118 SE DECISION MADE: 24-FEB-12 BALTIMORE MD 21202 510(k) STATEMENT DEVICE: MEDIGUIDE TECHNOLOGY ST. JUDE MEDICAL, MEDIGUIDE NAVIGA510(k) NO: K120301(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202 637 5794 COLUMBIA SQUARE 555 THIRTEENTH, NWSE DECISION MADE: 24-FEB-12 WASHINGTON DC 20004 1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRU LEGIONELLA MERIDIAN BIOSCIENCE, INC. 510(k) NO: K113190(TRADITIONAL)
ATTN: SUSAN BOGAR PHONE NO : 513 271 3700 3471 RIVER HILLS DR. SE DECISION MADE: 24-FEB-12 CINCINNATI OH 45244 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENVOY DISTAL ACCESS GUIDING CATHETER CODMAN & SHURTLEFF, INC. 510(k) NO: K120229(SPECIAL)
ATTN: CATHERINE KILSHAW PHONE NO : 508 828 3312 325 PARAMOUNT DR. SE DECISION MADE: 24-FEB-12 RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM SINTEA PLUSTEK, LLC 510(k) NO: K112861(SPECIAL) ATTN: DANIELLE WERNIKOWSKI PHONE NO : 305 673 6226 407 LINCOLN ROAD, SUITE 10L SE DECISION MADE: 24-FEB-12 MIAMI BEACH FL 33139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SITESCRUB IPA DEVICE CR BARD 510(k) NO: K112791(TRADITIONAL) ATTN: LYNN M KIRCHOFF PHONE NO : 801 522 5636 605 NORTH 5600 WEST SE DECISION MADE: 24-FEB-12 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 14 WIRE STANDARD, 14 WIRE LS MICRO THERAPEUTICS, INC. 510(k) NO: K113454(TRADITIONAL)
ATTN: GREGORY J GEISSINGER PHONE NO : 949 297 9781 9775 TOLEDO WAY SE DECISION MADE: 24-FEB-12 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Q50 PLUS STENT GRAFT BALLOON CATHETER QXMEDICAL, LLC 510(k) NO: K120381(TRADITIONAL)
ATTN: PHONE NO : 1747 SUMMIT AVENUE SE DECISION MADE: 24-FEB-12 ST. PAUL MN 55105 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) SHANTOU WEALY MEDICAL INSTRUMENT C510(k) NO: K113587(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931 625 4938 77325 JOYCE WAY SE DECISION MADE: 24-FEB-12 ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO SET REUSABLE OXIMETRY SENSORS MASIMO CORPORATION 510(k) NO: K113596(SPECIAL)
ATTN: DAVID COLLETTE PHONE NO : 949 297 7473 40 PARKER SE DECISION MADE: 24-FEB-12 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOOD PRESSURE MONITOR NIHON SEIMITSU SOKKI CO., LTD. 510(k) NO: K112690(TRADITIONAL) ATTN: KOJI KUBO PHONE NO : 81 359 816880 6-5-3 BEAUNE HONKOMAGOME 2F HONKOMSE DECISION MADE: 24-FEB-12 BUNKYO-KU, TOKYO JA 113-0021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOOD PRESSURE MONITOR NIHON SEIMITSU SOKKI CO., LTD. 510(k) NO: K112691(TRADITIONAL) ATTN: KOJI KUBO PHONE NO : 81 359 816880 6-5-3 BEAUNE HONKOMAGOME 2F HONKOMSE DECISION MADE: 24-FEB-12 BUNKYO-KU, TOKYO JA 113-0021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONNEX WORKSTATION WELCH ALLYN, INC. 510(k) NO: K120343(SPECIAL)
ATTN: KEVIN CROSSEN PHONE NO : 315 685 2609 4341 STATE ST. RD. PO BOX 220 SE DECISION MADE: 24-FEB-12 SKANEATELES FALLS NY 13153 0220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIFORCE RX240 EIZO NANAO CORPORATION 510(k) NO: K113844(TRADITIONAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 817 627 42468 153 SHIMOKASHIWANO, HAKUSAN SE DECISION MADE: 27-FEB-12 ISHIKAWA JA 924-8566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARF BAND DOODLEBUG PRODUCTS, LLC 510(k) NO: K110821(TRADITIONAL) ATTN: BARRY E SANDS PHONE NO : 978 363 5277 5 HEMINGWAY LANE SE DECISION MADE: 27-FEB-12 WEST NEWBURY MA 01985 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K113545(TRADITIONAL)
ATTN: SUSAN KAGAN PHONE NO : 508 880 8097 325 PARAMOUNT DR. SE DECISION MADE: 27-FEB-12 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CATALYST C-RAD POSITIONING AB 510(k) NO: K113276(TRADITIONAL)
ATTN: JANINA OSTLING PHONE NO : 481 866 6930 BREDGRAND 18 SE DECISION MADE: 27-FEB-12 UPPSALA SW 75320 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-RAY VVA MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K112807(TRADITIONAL) ATTN: D.J.W. BIERHUIZEN PHONE NO : 317 152 23244 9 SCHUTTERSVELD SE DECISION MADE: 27-FEB-12 LEIDEN NL 2316 XG 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOURNEY II DEEP DISHED ARTICULAR INSERTS SMITH & NEPHEW, INC. 510(k) NO: K113482(TRADITIONAL)
ATTN: SHEREEN MYERS PHONE NO : 901 399 6325 1450 BROOKS RD. SE DECISION MADE: 27-FEB-12 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WARP10,WARP75 QUANTUM DEVICES, INC. 510(k) NO: K113231(TRADITIONAL)
ATTN: MORRIS WAXLER PHONE NO : 608 219 7547 1920 ARLINGTON PL. SE DECISION MADE: 27-FEB-12 MEDISON WI 53726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPRESSIBLE LIMB THERAPY SYSTEM WONJINMULSAN CO., LTD. 510(k) NO: K113275(TRADITIONAL)
ATTN: EILEEN YANG PHONE NO : 824 247 62977 D-524 MIGUN TECHNO WORLD 2 533-1 YSE DECISION MADE: 27-FEB-12 DAEJEON KS KS 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIONIME DIABETES MANAGEMENT SYSTEM VI.0 BIONIME CORPORATION 510(k) NO: K113007(TRADITIONAL) ATTN: FENG-YU LEE PHONE NO : 949 951 3046 27001 LA PAZ RD. SUITE 266B SE DECISION MADE: 27-FEB-12 MISSION VIEJO CA 92691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS THE BINDING SITE 510(k) NO: K103824(TRADITIONAL) ATTN: SUZANNE HORNE PHONE NO : 440 121 4361000 PO BOX 11712 SE DECISION MADE: 27-FEB-12 BIRMINGHAM UK B14 4ZB 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM TIANJIN EMPECS MEDICAL DEVICE CO.,510(k) NO: K111456(TRADITIONAL) ATTN: HL JUNG PHONE NO : 82 314 4457889 RM 1301, GYEONGGI VENT. ANYANG SCISE DECISION MADE: 28-FEB-12 MANAN-GU ANYANG-SI GYEONGGI-DO 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TISSUE MARKER FOCAL THERAPEUTICS 510(k) NO: K113202(TRADITIONAL)
ATTN: GEORGE HERMANN PHONE NO : 650 530 2394 4370 ALPINE RD. #101 SE DECISION MADE: 28-FEB-12 PORTOLA VALLEY CA 94028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE BIOMERIEUX, INC. 510(k) NO: K111893(TRADITIONAL) ATTN: JOLYN TENLLADO PHONE NO : 314 731 8386 595 ANGLUM RD. SE DECISION MADE: 28-FEB-12 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOSHIBA 1.5T CARDIAC COIL QUALITY ELECTRODYNAMICS 510(k) NO: K120290(TRADITIONAL)
ATTN: CHRISTIE ZYDYK PHONE NO : 440 484 2228 700 BETA DRIVE SUITE 100 SE DECISION MADE: 28-FEB-12 MAYFIELD VILLAGE OH 44143 0000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOSAIQ ONCOLOGY INFORMATION SYSTEM IMPAC MEDICAL SYSTEMS, INC. 510(k) NO: K120067(TRADITIONAL)
ATTN: KATHRYN STINSON PHONE NO : 408 830 8000 100 MATHILDA PLACE 5TH FLOOR SE DECISION MADE: 28-FEB-12 SUNNYVALE CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEON SYSTEM ULRICH GMBH & CO. KG 510(k) NO: K113346(TRADITIONAL)
ATTN: HANS STOVER PHONE NO : 636 519 0268 612 TRADE CENTER BLVD SE DECISION MADE: 28-FEB-12 CHESTERFIELD MO 63005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MECTALIF TRANSFORAMINAL MEDACTA INTERNATIONAL, SA 510(k) NO: K120024(SPECIAL)
ATTN: ADAM GROSS PHONE NO : 805 437 7085 4725 CALLE QUETZAL UNIT B SE DECISION MADE: 28-FEB-12 CAMARILLO CA 93012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-PASS SYNEXMED(SHENZHEN)COMPANY LIMITED 510(k) NO: K113148(TRADITIONAL)
ATTN: TONY ZHANG PHONE NO : 867 558 3580375 B-11/F,Z Z Y BUILD.,TAOHUA RD. FUTSE DECISION MADE: 28-FEB-12 SHENZHEN CH 518038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX REVISION KNEE SYSTEMS OMNI LIFE SCIENCE, INC. 510(k) NO: K112891(TRADITIONAL) ATTN: CHRISTINE NASSIF PHONE NO : 774 226 1871 50 O'CONNELL WAY SE DECISION MADE: 29-FEB-12 EAST TAUNTON MA 02718 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTUM BARIATRIC 451 PRIDE MOBILITY PRODUCT CORPORRATIO510(k) NO: K112815(SPECIAL) ATTN: KIMBERLY BLAKE PHONE NO : 570 655 5574 182 SUSQUEHANNA AVE. SE DECISION MADE: 29-FEB-12 EXETER PA 18643 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONO TAP, TUOHY SONO PAJUNK GMBH 510(k) NO: K113207(TRADITIONAL)
ATTN: CHRISTIAN QUASS PHONE NO : 049 770 49291586 KARL-HALL-STRASSE 1 SE DECISION MADE: 29-FEB-12 GEISINGEN GM D-78187 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNANAIL ANKLE ARTHRODESIS NAIL MEDSHAPE, INC 510(k) NO: K113828(TRADITIONAL)
ATTN: JEREMY BLAIR PHONE NO : 404 583 6889 1575 NORTHSIDE DRIVE, SUITE 440 SE DECISION MADE: 29-FEB-12 ATLANTA GA 30318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE SPINEOLOGY, INC. 510(k) NO: K120293(SPECIAL)
ATTN: BRYAN BECKER PHONE NO : 651 256 8534 7800 3RD ST N., SUITE 600 SE DECISION MADE: 29-FEB-12 ST. PAUL MN 55128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K120258(TRADITIONAL)
ATTN: JENNIFER BRENNAN PHONE NO : 203 492 5346 60 Middletown Ave SE DECISION MADE: 29-FEB-12 North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INOMAX DS(DELIVERY SYSTEMS INO THERAPEUTICS LLC/DBA IKARIA 510(k) NO: K113272(SPECIAL)
ATTN: LARRY LEPLEY PHONE NO : 608 226 3415 2902 Dairy Dr SE DECISION MADE: 29-FEB-12 MADISON WI 53718 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEANE / CLEANE POP MEDICON CO., LTD. 510(k) NO: K111341(TRADITIONAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080 951 STARBUCK ST. UNIT J SE DECISION MADE: 29-FEB-12 FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 7MM LCP ULNU OSTEOTOMY SYSTEM SYNTHES (USA) PRODUCTS LLC 510(k) NO: K113364(TRADITIONAL)
ATTN: REBECCA BLANK PHONE NO : 610 719 1268 1303 Goshen Pkwy SE DECISION MADE: 29-FEB-12 West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEALIX ADVANCE BR ANCHOR DEPUY MITEK INC., JOHNSON AND JOHN510(k) NO: K120078(TRADITIONAL)
ATTN: YAYOI FUJIMAKI PHONE NO : 508 828 3541 325 PARAMOUNT DRIVE SE DECISION MADE: 29-FEB-12 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANGUARD COMPLETE KNEE SYSTEM BIOMET MANUFACTURING CORP. 510(k) NO: K113550(TRADITIONAL)
ATTN: GARY BAKER PHONE NO : 574 371 6639 56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 29-FEB-12 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 238 TOTAL WITH SUMMARIES 219 TOTAL WITH STATEMENTS 19