SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-MAY-2008 THROUGH 31-MAY-2008 DEVICE: U-CLIP UNI-FIRE, MODEL M65 MEDTRONIC INC. 510(k) NO: K081082(TRADITIONAL)
ATTN: DAVID D COX PHONE NO : 651-247-7900 3051 S. NEWCOMBE WAY SE DECISION MADE: 07-MAY-08 LAKEWOOD, CO 80227 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO 3M TEGADERM CHG DRESSING 3M COMPANY-3M HEALTH CARE 510(k) NO: K080620(SPECIAL)
ATTN: MARIA RUIZ PHONE NO : 651-736-2733 3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 19-MAY-08 ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM ABIOMED, INC. 510(k) NO: K063723(TRADITIONAL)
ATTN: ROBERT T KUNG PHONE NO : 978-646-1440 22 CHERRY HILL DR. SE DECISION MADE: 30-MAY-08 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHELL CAGE, WAVE CAGE, LOOP CAGE ADVANCED MEDICAL TECHNOLOGIES AG 510(k) NO: K080401(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD. SE DECISION MADE: 09-MAY-08 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AOS PROXIMAL HUMERAL PLATE ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K080590(TRADITIONAL)
ATTN: PAUL DONER PHONE NO : 310-533-9966 2444 205TH STREET, UNIT 5 SE DECISION MADE: 06-MAY-08 TORRANCE, CA 90501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106 AESCULAP IMPLANT SYSTEM, INC. 510(k) NO: K080547(SPECIAL)
ATTN: MATTHEW M HULL PHONE NO : 610-984-9072 3773 CORPORATE PARKWAY SE DECISION MADE: 23-MAY-08 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METHA SHORT STEM HIP SYSTEM AESCULAP IMPLANT SYSTEM, INC. 510(k) NO: K080584(TRADITIONAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-984-9291 3773 CORPORATE PARKWAY SE DECISION MADE: 09-MAY-08 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPA AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K071983(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 610-984-9072 3773 CORPORATE PKWY. SE DECISION MADE: 01-MAY-08 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE AESCULAP, INC. 510(k) NO: K081031(SPECIAL)
ATTN: LISA BOYLE PHONE NO : 610-797-9300 3773 CORPORATE PKWY. SE DECISION MADE: 05-MAY-08 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESKULISA ANA HEP-2, REF 30-7115US AESKU.DIAGNOSTICS 510(k) NO: K081104(TRADITIONAL)
ATTN: JIM RADFORD PHONE NO : 770 982 6389 MIKROFORUM RING 2 SE DECISION MADE: 02-MAY-08 WENDELSHEIM, GERMANY D-55234 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: MODIFICATION TO AESKULISA DS DNA G AESKU.DIAGNOSTICS 510(k) NO: K081251(SPECIAL)
ATTN: SASCHA PFEIFFER PHONE NO : 49 673 496270 MIKROFORUM RING 2 SE DECISION MADE: 13-MAY-08 WENDELSHEIM, GERMANY D-55234 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AMPLATZER TORQVUE EXCHANGE SYSTEM AGA MEDICAL CORP. 510(k) NO: K080994(TRADITIONAL)
ATTN: MICHELLE NIVALA PHONE NO : 763-531-3061 5050 NATHAN LANE NORTH SE DECISION MADE: 16-MAY-08 PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALCON VISION SYSTEM ALCON 510(k) NO: K063583(TRADITIONAL)
ATTN: TERRY J DAGNON PHONE NO : 817-551-4325 6201 SOUTH FREEWAY, R7-20 SE DECISION MADE: 09-MAY-08 FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM ALMA LASERS LTD. 510(k) NO: K072564(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 925-426-8927 3637 BERNAL AVE. SE DECISION MADE: 23-MAY-08 PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BI-RADS COMPANION ALMEN LABORATORIES, INC. 510(k) NO: K072258(TRADITIONAL)
ATTN: ROGER H SCHNEIDER PHONE NO : 301-229-8442 6319 MASSACHUSETTS AVENUE SE DECISION MADE: 16-MAY-08 BETHESDA, MD 20816-1139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVEL SPINAL SPACER SYSTEM ALPHATEC SPINE, INC. 510(k) NO: K080699(TRADITIONAL)
ATTN: MARY STANNERS PHONE NO : 760-494-6771 2051 PALOMAR AIRPORT ROAD SE DECISION MADE: 21-MAY-08 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA CARLSBAD, CA 92011 DEVICE: RAPID TOX CUP AMERICAN BIO MEDICA CORP. 510(k) NO: K073078(TRADITIONAL)
ATTN: RICH REILLY PHONE NO : 856-241-2320 603 HERON DR. SE DECISION MADE: 30-MAY-08 UNIT 3 510(k) SUMMARY AVAILABLE FROM FDA LOGAN TOWNSHIP, NJ 08085 DEVICE: AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM AMERICAN DENTAL IMPLANT CORPORATIO510(k) NO: K080397(TRADITIONAL)
ATTN: GINA HENNON PHONE NO : 724-657-0718 2415 WILMINGTON RD. SE DECISION MADE: 06-MAY-08 NEW CASTLE, PA 16105 510(k) STATEMENT DEVICE: ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE ANGIODYNAMICS, INC. 510(k) NO: K080400(TRADITIONAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215 603 QUEENSBURY AVE. SE DECISION MADE: 13-MAY-08 QUEENSBURY, NY 12804 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER ANGIOSCORE, INC. 510(k) NO: K081220(SPECIAL)
ATTN: KIMBERLEY KLINE PHONE NO : 510-933-7989 5055 BRANDIN COURT SE DECISION MADE: 28-MAY-08 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE ANIMAS CORP. 510(k) NO: K080587(TRADITIONAL)
ATTN: JENNIFER BOSLEY PHONE NO : 484-568-1082 200 LAWRENCE DR. SE DECISION MADE: 15-MAY-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CPAP MASK ARCIMED LABORATORIES LLC 510(k) NO: K071915(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155 24301 WOODSAGE DRIVE SE DECISION MADE: 14-MAY-08 BONITA SPRINGS, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROVOX MICRON HME ATOS MEDICAL AB 510(k) NO: K072582(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155 24301 WOODSAGE DRIVE SE DECISION MADE: 30-MAY-08 BONITA SPRINGS, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 B-K MEDICAL APS 510(k) NO: K081154(SPECIAL)
ATTN: JENS RASMUSSEN PHONE NO : 011 45 44528100 MILEPARKEN 34 SE DECISION MADE: 23-MAY-08 HERLEV, DENMARK DK-2730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORONIS 5MP MAMMO SL, MODEL MDMG 6121 BARCOVIEW, MEDICAL IMAGING SYSTEMS510(k) NO: K081109(TRADITIONAL)
ATTN: NEIL PHILLIPS PHONE NO : 32 56 233211 35 PRESIDENT KENNEDYPARK SE DECISION MADE: 02-MAY-08 KORTRIJK, BELGIUM B-8500 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: BARD E LUMINEXX BILIARY STENT BARD PERIPHERAL VASCULAR, INC. 510(k) NO: K063532(TRADITIONAL)
ATTN: LINDSAY K PACK PHONE NO : 480-379-2838 P.O. BOX 1740 SE DECISION MADE: 30-MAY-08 TEMPE, AZ 85280-1740 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNI-TIGHT BASIC DENTAL IMPLANT SYSTEMS, INC.510(k) NO: K072595(SPECIAL)
ATTN: RICH WEISKOPF PHONE NO : 303-341-4255 535 ZANG STREET SE DECISION MADE: 09-MAY-08 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA LAKEWOOD, CO 80228 DEVICE: NRG TRANSSEPTAL NEEDLE BAYLIS MEDICAL CO., INC. 510(k) NO: K073326(TRADITIONAL)
ATTN: MEGHAL KHAKHAR PHONE NO : 905 602 4875 2645 MATHESON BLVD. E SE DECISION MADE: 28-MAY-08 MISSISSAUGA, ONTARIO, CANADA L4W 5510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG BECKMAN COULTER, INC. 510(k) NO: K080869(TRADITIONAL)
ATTN: DAVID M IKEDA PHONE NO : 952-368-1361 1000 LAKE HAZELTINE DR. SE DECISION MADE: 23-MAY-08 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DORIPENEM 10UG BBL SENSI-DISC BECTON DICKINSON & CO. 510(k) NO: K080998(TRADITIONAL)
ATTN: JANINE MATLAK PHONE NO : 410-316-4938 7 LOVETON CIR. SE DECISION MADE: 12-MAY-08 SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLATELIA LYME IGG ASSAY BIO-RAD 510(k) NO: K080012(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808 163 CABOT ST. SE DECISION MADE: 08-MAY-08 BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN BIO-RAD LABORATORIES INC., CLINICA510(k) NO: K080911(SPECIAL)
ATTN: J.B BARTILSON PHONE NO : 510-741-6114 4000 ALFRED NOBEL DR. SE DECISION MADE: 02-MAY-08 HERCULES, CA 94547 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMERS TRANSLUCENT ORTHODONTIC WIRE BIOMERS PRODUCT, LLC 510(k) NO: K081143(TRADITIONAL)
ATTN: GEORGE ALIPHTIRAS PHONE NO : 239-776-6344 2316 PINE RIDGE ROAD SE DECISION MADE: 02-MAY-08 SUITE 459 510(k) SUMMARY AVAILABLE FROM FDA NAPLES, FL 34109 THIRD PARTY REVIEW DEVICE: FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) BIOMET MICROFIXATION, INC. 510(k) NO: K081067(SPECIAL)
ATTN: KIM REED PHONE NO : 904-741-9443 1520 TRADEPORT DR. SE DECISION MADE: 09-MAY-08 JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM BIOMET SPINE 510(k) NO: K080646(TRADITIONAL)
ATTN: JACQUELYN A HUGHES PHONE NO : 973-299-9300 100 INTERPACE PARKWAY SE DECISION MADE: 02-MAY-08 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSYAG MEDICAL SYSTEM BIOS S.R.L. 510(k) NO: K080374(TRADITIONAL)
ATTN: ALESSANDRO FRANCHI PHONE NO : 240-305-6868 4235 E. BROADWAY SE DECISION MADE: 15-MAY-08 LONG BEACH, CA 90803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCOUTPRO CS LEAD INTRODUCER SYSTEM BIOTRONIK, INC. 510(k) NO: K080988(SPECIAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374 6024 JEAN ROAD SE DECISION MADE: 07-MAY-08 LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIRDENT CAD/CAM BLOCKS C5 MEDICAL WERKS, INC. 510(k) NO: K081253(TRADITIONAL)
ATTN: HOMER GREGORY PHONE NO : 970-683-7900 2451 RIVER RD. SE DECISION MADE: 15-MAY-08 GRAND JUNCTION, CO 81505 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: T34L SYRINGE DRIVER CAESAREA MEDICAL ELECTRONICS LTD. 510(k) NO: K080954(SPECIAL)
ATTN: EVA PARTAS PHONE NO : 972 462 71737 16 SHACHAM STREET SE DECISION MADE: 16-MAY-08 INDUSTRIAL PARK 510(k) STATEMENT CAESAREA, ISRAEL 38900 DEVICE: DESARA MESH SLING, MODEL CAL-DS01 CALDERA MEDICAL, INC. 510(k) NO: K072456(SPECIAL)
ATTN: CHRISTINE EMANUEL PHONE NO : 805-963-4312 1205 DE LA VINA SE DECISION MADE: 08-MAY-08 SANTA BARBARA, CA 93101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALYPSO 4D LOCALIZATION SYSTEM CALYPSO MEDICAL TECHNOLOGIES INC 510(k) NO: K080726(TRADITIONAL)
ATTN: ERIC MEIER PHONE NO : 206-774-4205 2101 FOURTH AVE SE DECISION MADE: 14-MAY-08 SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA SEATTLE, WA 98121 DEVICE: CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K081257(SPECIAL)
ATTN: ALEX GONOROVSKY PHONE NO : 972 8 9484070 2 PEKERIS ST., SCIENCE PARK SE DECISION MADE: 29-MAY-08 REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167 CELON AG MEDICAL INSTRUMENTS 510(k) NO: K073207(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 484-896-5688 3500 CORPORATE PARKWAY SE DECISION MADE: 08-MAY-08 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERABOND ANTIMICROBIAL BARRIER SYSTEMS CHOICE THERAPEUTICS 510(k) NO: K073213(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813 COLUMBIA SQUARE SE DECISION MADE: 28-MAY-08 555 THIRTEENTH STREET NW 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20004 DEVICE: COLLAGEN TENDON WRAP COLLAGEN MATRIX, INC. 510(k) NO: K080452(TRADITIONAL)
ATTN: PEGGY HANSEN PHONE NO : 201-405-1477 509 COMMERCE ST. SE DECISION MADE: 15-MAY-08 FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE COLUMBIA SCIENTIFIC DEVELOPMENT LL510(k) NO: K080386(TRADITIONAL)
ATTN: STEPHEN SHULMAN PHONE NO : 734-663-0132 420 NW 11TH AVENUE SE DECISION MADE: 30-MAY-08 SUITE 617 510(k) SUMMARY AVAILABLE FROM FDA PORTLAND, OR 97209 THIRD PARTY REVIEW DEVICE: CONCEIVEX LATEX-FREE SEMEN COLLECTOR CONCEIVEX INC. 510(k) NO: K080752(SPECIAL)
ATTN: BLIX WINSTON PHONE NO : 301-607-9185 2600 MULLINIX MILL ROAD SE DECISION MADE: 14-MAY-08 MT. AIRY, MD 21771-0031 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6. CONFORMIS, INC. 510(k) NO: K080936(TRADITIONAL)
ATTN: S. MICHAEL SHARP PHONE NO : 781-860-5111 2 FOURTH AVENUE SE DECISION MADE: 12-MAY-08 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX CONMED ENDOSCOPIC TECHNOLOGIES, IN510(k) NO: K080946(TRADITIONAL)
ATTN: BETH ZIS PHONE NO : 978-964-4251 129 CONCORD RD. SE DECISION MADE: 20-MAY-08 BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FINGERTIP PULSE OXIMETER, MODEL CMS-50C CONTEC MEDICAL SYSTEM CO., LTD. 510(k) NO: K073454(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467 SUITE 8D , ZHONGXIN ZHONGSHAN SE DECISION MADE: 05-MAY-08 MANSION, NO. 19, LANE 999, 510(k) SUMMARY AVAILABLE FROM FDA ZHONG SHAN, SHANGHAI, CHINA 20030 DEVICE: AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING CONVATEC, A DIVISION OF E.R. SQUIB510(k) NO: K080383(TRADITIONAL)
ATTN: MARILYN KONICKY PHONE NO : 908-904-2541 200 HEADQUARTERS PARK DR. SE DECISION MADE: 02-MAY-08 SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVOLUTION ESOPHAGEAL STENT SYSTEM COOK IRELAND LTD 510(k) NO: K080359(TRADITIONAL)
ATTN: NOREEN BARRY PHONE NO : 353 61 334400 O'HALLORAN ROAD SE DECISION MADE: 09-MAY-08 NATIONAL TECHNOLOGY PARK 510(k) SUMMARY AVAILABLE FROM FDA LIMERICK, IRELAND DEVICE: TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRU CORDIS NEUROVASCULAR, INC. 510(k) NO: K080967(SPECIAL)
ATTN: AMARILYS MACHADO PHONE NO : 786-313-6493 14201 NW 60TH AVENUE SE DECISION MADE: 02-MAY-08 MIAMI LAKES, FL 33014 510(k) STATEMENT DEVICE: AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR COVIDIEN LP, FORMERLY REGISTERED A510(k) NO: K081169(SPECIAL)
ATTN: TIM LOHNES PHONE NO : 203-492-5462 60 MIDDLETOWN AVENUE SE DECISION MADE: 23-MAY-08 NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM CREASPINE 510(k) NO: K080860(TRADITIONAL)
ATTN: CYNTHIA J NOLTE PHONE NO : 919-859-4207 49 PLAIN ST. SE DECISION MADE: 29-MAY-08 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL CURBELL ELECTRONICS INC. 510(k) NO: K080605(SPECIAL)
ATTN: MICHAEL J WINTER PHONE NO : 716-667-3377 20 CENTRE DR. SE DECISION MADE: 05-MAY-08 ORCHARD PARK, NY 14127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATHWAY CUSTOM SPINE, INC. 510(k) NO: K080281(TRADITIONAL)
ATTN: SAAD ATTIYAH PHONE NO : 973-265-5036 1140 PARSIPPANY BLVD. SE DECISION MADE: 01-MAY-08 SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA PARSIPPANY, NJ 07054 DEVICE: SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULS CYNOSURE, INC. 510(k) NO: K081181(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200 5 CARLISLE ROAD SE DECISION MADE: 05-MAY-08 WESTFORD, MA 01886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTRON SENSOR DENTRON SYSTEMS LLC 510(k) NO: K080738(TRADITIONAL)
ATTN: CLAUDE D BERTHOIN PHONE NO : 800-323-2690 11 EAST GRANADA BLVD. SE DECISION MADE: 13-MAY-08 SUITE 207 510(k) SUMMARY AVAILABLE FROM FDA ORMOND BEACH, FL 32176 DEVICE: PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION DENTSPLY INTERNTIONAL 510(k) NO: K081291(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511 221 W. PHILADELPHIA ST. STE.60 SE DECISION MADE: 22-MAY-08 SUSQUEHANNA COMMERCE CRT. WEST 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17405 DEVICE: CAIS STAPLE DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K073281(TRADITIONAL)
ATTN: RUTH C FORSTADT PHONE NO : 508-977-3988 325 PARAMOUNT DR. SE DECISION MADE: 02-MAY-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTSET MV BONE CEMENT DEPUY ORTHOPAEDICS, INC. 510(k) NO: K081155(SPECIAL)
ATTN: SUZANA OTANO PHONE NO : 305-269-6386 700 ORTHOPAEDIC DR. SE DECISION MADE: 14-MAY-08 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTSET GMV GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC. 510(k) NO: K081163(SPECIAL)
ATTN: SUZANA OTANO PHONE NO : 305-269-0386 700 ORTHOPAEDIC DR. SE DECISION MADE: 14-MAY-08 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VIPER SPINE SYSTEM DEPUY SPINE, INC. 510(k) NO: K073562(TRADITIONAL)
ATTN: CHRISTOPHER KLACZYK PHONE NO : 508-828-2852 325 PARAMOUNT DR. SE DECISION MADE: 15-MAY-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. 510(k) NO: K080313(SPECIAL)
ATTN: CHRISTOPHER KLACZYK PHONE NO : 508-828-2852 325 PARAMOUNT DR. SE DECISION MADE: 08-MAY-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-MESH EXPANDABLE CAGE SYSTEM DEPUY SPINE, INC. 510(k) NO: K080568(SPECIAL)
ATTN: HANDE TUFAN PHONE NO : 508-828-3065 325 PARAMOUNT DR. SE DECISION MADE: 01-MAY-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPEDIUM 4.5MM SPINE SYSTEM DEPUY SPINE, INC. 510(k) NO: K081252(SPECIAL)
ATTN: CHRISTOPHER KLACZYK PHONE NO : 508-828-2852 325 PARAMOUNT DR. SE DECISION MADE: 30-MAY-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEMPTOUCH DERMAL THERMOMETER DIABETICA SOLUTIONS, INC. 510(k) NO: K081162(TRADITIONAL)
ATTN: J.S. ALLINSON PHONE NO : 210-692-1114 12665 SILICON DRIVE SE DECISION MADE: 08-MAY-08 SAN ANTONIO, TX 78249 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PROLYTE ELECTROLYTE ANALYZER DIAMOND DIAGNOSTICS, INC. 510(k) NO: K070104(TRADITIONAL)
ATTN: RANDOLPH QUINN PHONE NO : 508-429-0450 333 FISKE ST. SE DECISION MADE: 07-MAY-08 HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS DIMA ITALIA SRL 510(k) NO: K072290(TRADITIONAL)
ATTN: LEWIS WARD PHONE NO : 303-530-3279 4655 KIRKWOOD CT. SE DECISION MADE: 29-MAY-08 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIO BIOTITE-H IMPLANT SYSTEM DIO DEPARTMENT DSI, INC. 510(k) NO: K073070(TRADITIONAL)
ATTN: STEVE CHANG PHONE NO : 562-404-8466 13340 E. FIRESTONE BLVD SE DECISION MADE: 16-MAY-08 SUITE J 510(k) SUMMARY AVAILABLE FROM FDA SANTA FE SPRINGS, CA 90670 DEVICE: SM-EXTRA WIDE (RBM) IMPLANT SYSTEM DIO DEPARTMENT DSI, INC. 510(k) NO: K080128(TRADITIONAL)
ATTN: HYUNGICK KIM PHONE NO : 213-365-2875 3540 WILSHIRE BLVD. SE DECISION MADE: 14-MAY-08 SUITE 1104 510(k) SUMMARY AVAILABLE FROM FDA LOS ANGELES, CA 90010 DEVICE: SECURE IMPLANT SYSTEM (2.5/3.0MM) DIO DEPARTMENT DSI, INC. 510(k) NO: K080129(TRADITIONAL)
ATTN: HYUNGICK KIM PHONE NO : 213-365-2875 3540 WILSHIRE BLVD. SE DECISION MADE: 30-MAY-08 SUITE 1104 510(k) SUMMARY AVAILABLE FROM FDA LOS ANGELES, CA 90010 DEVICE: DENTAL CERAMIC DMG USA, INC. 510(k) NO: K080479(ABBREVIATED)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVE. SE DECISION MADE: 21-MAY-08 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NANOCOMPOSITE RESTORATIVE KIT DMG USA, INC. 510(k) NO: K080480(ABBREVIATED)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVE. SE DECISION MADE: 30-MAY-08 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR E1 ENT., INC. 510(k) NO: K080385(TRADITIONAL)
ATTN: JACK CHENG PHONE NO : 800-367-6160 1290 S.W. 30TH AVE. SE DECISION MADE: 13-MAY-08 POMPANO BEACH, FL 33069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEMUS SYSTEM; NEMUS PC PERIPHERAL EB NEURO, S.P.A. 510(k) NO: K073415(TRADITIONAL)
ATTN: ALLISON SCOTT PHONE NO : 317-569-9500 11460 N. MERIDIAN ST. SE DECISION MADE: 23-MAY-08 SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA CARMEL, IN 46032 DEVICE: MUCOGRAFT COLLAGEN MATRIX ED. GEISTLICH SOEHNE AG FUER CHEMI510(k) NO: K073711(TRADITIONAL)
ATTN: PETER S REICHERTZ PHONE NO : 202-772-5333 1300 I STREET, N.W. SE DECISION MADE: 30-MAY-08 11TH FLOOR EAST 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: DEL SOL RED LIGHT THERAPY SYSTEM EDGE SYSTEMS, INC. 510(k) NO: K072399(TRADITIONAL)
ATTN: GARY MOCNIK PHONE NO : 949-433-0413 24372 MCCLOUD CT. SE DECISION MADE: 23-MAY-08 LAGUNA NIGUEL, CA 92677 510(k) STATEMENT DEVICE: 3-D IMAGING WORKSTATION EIGEN LLC 510(k) NO: K081093(TRADITIONAL)
ATTN: MARK A HOFFMAN PHONE NO : 530-274-1240 13366 GRASS VALLEY AVE. SE DECISION MADE: 01-MAY-08 GRASS VALLEY, CA 95945 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LEKSELL SURGIPLAN, MODEL 1006947 ELEKTA INSTRUMENT AB 510(k) NO: K080250(SPECIAL)
ATTN: PETER LOWENDAHL PHONE NO : 011 468 58725400 KUNGSTENSGATAN 18 SE DECISION MADE: 13-MAY-08 P.O.BOX 7593 510(k) SUMMARY AVAILABLE FROM FDA STOCKHOLM, SWEDEN S-103 93 DEVICE: ESA BIOSCIENCES INC. VITAMIN D HPLC TEST ESA BIOSCIENCES INC. 510(k) NO: K072536(TRADITIONAL)
ATTN: HAROLD ASP PHONE NO : 978-250-7106 22 ALPHA RD. SE DECISION MADE: 07-MAY-08 CHELMSFORD, MA 01824-4171 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHELON GRAY CARTRIDGE, MODEL ERC45M ETHICON ENDO-SURGERY, LLC 510(k) NO: K080839(TRADITIONAL)
ATTN: RUTH ANN WOOD PHONE NO : 513-337-3566 4545 CREEK ROAD SE DECISION MADE: 21-MAY-08 CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS ETHICON, INC. 510(k) NO: K071512(TRADITIONAL)
ATTN: BRYAN A LISA PHONE NO : 908-218-3392 P.O. BOX 151 SE DECISION MADE: 15-MAY-08 SOMERVILLE, NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURESKIN SILVER BANDAGES EUROMED, INC. 510(k) NO: K081274(TRADITIONAL)
ATTN: SUBHASH CHANDER PHONE NO : 845-359-4039 25 CORPORATE DRIVE SE DECISION MADE: 28-MAY-08 ORANGEBURG, NY 10962 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS EXACTECH, INC. 510(k) NO: K080980(SPECIAL)
ATTN: XAVIER SARABIA PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 06-MAY-08 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP GAYMAR INDUSTRIES, INC. 510(k) NO: K073675(TRADITIONAL)
ATTN: BETHANY J GILBERT PHONE NO : 716-848-1554 140 PEARL STREET, SUITE 100 SE DECISION MADE: 08-MAY-08 BUFFALO, NY 14202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A GE HEALTHCARE 510(k) NO: K071889(SPECIAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685 86 PILGRIM ROAD SE DECISION MADE: 19-MAY-08 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) GE HEALTHCARE 510(k) NO: K081105(TRADITIONAL)
ATTN: ANDREW MENDEN PHONE NO : 262-312-7086 3000 N. GRANDVIEW BLVD. SE DECISION MADE: 09-MAY-08 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OEC 9900 ELITE GE OEC MEDICAL SYSTEMS 510(k) NO: K073543(TRADITIONAL)
ATTN: MARIA C FRAME PHONE NO : 801-517-6440 384 WRIGHT BROTHERS DR. SE DECISION MADE: 02-MAY-08 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR GENZYME CORPORATION 510(k) NO: K080662(TRADITIONAL)
ATTN: ERIC LAWSON PHONE NO : 508-271-6774 31 NEW YORK AVENUE SE DECISION MADE: 15-MAY-08 FRAMINGHAM, MA 01701-9322 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVERE UNIPLANAR SCREWS GLOBUS MEDICAL INC. 510(k) NO: K081195(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 28-MAY-08 AUDUBON, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE GX CORPORATION SDN BHD 510(k) NO: K080937(TRADITIONAL)
ATTN: FOO K PU PHONE NO : 603 329 11600 LOT 6487A, BATU 5 3/4, SEMENTA SE DECISION MADE: 23-MAY-08 JALAN KAPAR 510(k) STATEMENT KLANG, MALAYSIA 42100 DEVICE: PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK GYRUS ACMI, INC. 510(k) NO: K080093(TRADITIONAL)
ATTN: TERRENCE E SULLIVAN PHONE NO : 508-804-2739 136 TURNPIKE RD. SE DECISION MADE: 02-MAY-08 SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DR HEMCON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K080818(TRADITIONAL)
ATTN: KEVIN HAWKINS PHONE NO : 503-245-0459 10575 SW CASCADE AVENUE SE DECISION MADE: 15-MAY-08 SUITE 130 510(k) SUMMARY AVAILABLE FROM FDA PORTLAND, OR 97223-4363 DEVICE: MAMMOSITE CAVITY EVALUATION DEVICE HOLOGIC, INC. 510(k) NO: K081179(TRADITIONAL)
ATTN: RANDALL J COVILL PHONE NO : 508-263-8853 250 CAMPUS DRIVE SE DECISION MADE: 09-MAY-08 MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OMEGA 3 TROCHANTERIC STABILIZING PLATE HOWMEDICA OSTEONICS CORP. 510(k) NO: K081278(SPECIAL)
ATTN: ANDREA DWYER PHONE NO : 201-831-6250 325 CORPORATE DRIVE SE DECISION MADE: 29-MAY-08 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM HYCOR BIOMEDICAL, INC. 510(k) NO: K081217(SPECIAL)
ATTN: P. NARAYAN NAYAK PHONE NO : 714-933-3145 7272 CHAPMAN AVE. SE DECISION MADE: 22-MAY-08 GARDEN GROVE, CA 92841 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HYGIA HEALTH SERVICES, INC. 510(k) NO: K080424(TRADITIONAL)
ATTN: JEROME JAMES PHONE NO : 205-314-3920 434 INDUSTRIAL LN. SE DECISION MADE: 28-MAY-08 BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRADUATED ADAPTER WITH CLAVE ICU MEDICAL, INC 510(k) NO: K080007(TRADITIONAL)
ATTN: TRACY BEST PHONE NO : 801-264-1332 4455 ATHERTON DR. SE DECISION MADE: 13-MAY-08 SALT LAKE CITY, UT 84123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIVERSAL VIAL ACCESS SPIKE ICU MEDICAL, INC 510(k) NO: K080989(SPECIAL)
ATTN: TRACY BEST PHONE NO : 801-264-1332 4455 ATHERTON DR. SE DECISION MADE: 02-MAY-08 SALT LAKE CITY, UT 84123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IB NEURO, VERSION 1.0 IMAGING BIOMETRICS, LLC 510(k) NO: K080762(TRADITIONAL)
ATTN: MICHAEL SCHMAINDA PHONE NO : 262-385-1796 1035 KATHERINE DR. SE DECISION MADE: 15-MAY-08 ELM GROVE, WI 53122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REACTIVE DENTAL IMPLANT SYSTEM IMPLANT DIRECT LLC 510(k) NO: K080713(TRADITIONAL)
ATTN: THOMAS GOTTENBOS PHONE NO : 818-444-3317 27030 MALIBU HILLS RD. SE DECISION MADE: 16-MAY-08 CALABASAS HILLS, CA 91301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ILUMA VISION IMTEC CORP. 510(k) NO: K081347(TRADITIONAL)
ATTN: BRAD VANCE PHONE NO : 580-223-4456 2401 NORTH COMMERCE SE DECISION MADE: 28-MAY-08 ARDMORE, OK 73401 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: INCLUSIVE IMPLANT ABUTMENTS INCLUSIVE DENTAL SOLUTIONS 510(k) NO: K073217(TRADITIONAL)
ATTN: KEITH D ALLRED PHONE NO : 949-440-2683 4141 MACARTHUR BLVD SE DECISION MADE: 14-MAY-08 NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LYRIC HEARING AID INSOUND MEDICAL INC. 510(k) NO: K081136(TRADITIONAL)
ATTN: SUSAN WHICHARD PHONE NO : 510-792-4000 39660 EUREKA DRIVE SE DECISION MADE: 08-MAY-08 NEWARK, CA 94560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS INSTITUT STRAUMANN AG 510(k) NO: K081005(SPECIAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168 60 MINUTEMAN ROAD SE DECISION MADE: 02-MAY-08 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONCAVE RN HEALING CAP INSTITUT STRAUMANN AG 510(k) NO: K081186(SPECIAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168 60 MINUTEMAN ROAD SE DECISION MADE: 23-MAY-08 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) INSTRUMENTATION LABORATORY CO. 510(k) NO: K073377(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 04-MAY-08 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES INTERNACIONAL FARMACEUTICA, S.A. D510(k) NO: K072859(TRADITIONAL)
ATTN: ALAN P SCHWARTZ PHONE NO : 516-482-9001 55 NORTHERN BLVD. SE DECISION MADE: 23-MAY-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL S INTERNACIONAL FARMACEUTICA, S.A. D510(k) NO: K072863(TRADITIONAL)
ATTN: ALLAN P SCHWARTZ PHONE NO : 516-482-9001 55 NORTHERN BLVD. SE DECISION MADE: 23-MAY-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS INTRA-LOCK INTERNATIONAL 510(k) NO: K080598(ABBREVIATED)
ATTN: JEFFREY SAKOFF PHONE NO : 561-447-8282 6560 WEST ROGERS CIRCLE SE DECISION MADE: 21-MAY-08 SUITE 24 510(k) SUMMARY AVAILABLE FROM FDA BOCA RATON, FL 33487 DEVICE: CORRIDOR4DM INVIA 510(k) NO: K080575(TRADITIONAL)
ATTN: F. DAVID ROTHKOPF PHONE NO : 508-231-8842 200 HOMER AVENUE SE DECISION MADE: 13-MAY-08 ASHLAND, MA 01721 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATCH-PAT MODEL 100S-2 ITAMAR MEDICAL 510(k) NO: K080427(TRADITIONAL)
ATTN: JONATHAN KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 23-MAY-08 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID JAS DIAGNOSTICS, INC. 510(k) NO: K080618(TRADITIONAL)
ATTN: SAMUEL BURGOS PHONE NO : 305-418-2320 7220 NW 58TH ST. SE DECISION MADE: 23-MAY-08 MIAMI, FL 33166 510(k) STATEMENT DEVICE: THERMOFLASH LX-26 JXB CO. LTD GUANGZHOU (CHINA) 510(k) NO: K080759(TRADITIONAL)
ATTN: TRAY CUI PHONE NO : 86 20 34936960 NO 38 HUANZHEN XI ROAD SE DECISION MADE: 12-MAY-08 DAGANG TOWN 510(k) SUMMARY AVAILABLE FROM FDA PANUY, GUANGZHOU, CHINA THIRD PARTY REVIEW DEVICE: KSEA CLEARVISION II, MODEL 40334120 KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K072410(TRADITIONAL)
ATTN: CRYSTAL DIZOL PHONE NO : 310-338-8100 600 CORPORATE POINTE SE DECISION MADE: 09-MAY-08 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BI KETTENBACH GMBH & CO KG 510(k) NO: K081120(TRADITIONAL)
ATTN: MICHAELA ZINKE PHONE NO : IM HEERFELD 7 SE DECISION MADE: 01-MAY-08 ESCHENBURG, GERMANY 35713 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT KRONUS MARKET DEVELOPMENT ASSOCIAT510(k) NO: K080159(TRADITIONAL)
ATTN: HEATHER VIELE PHONE NO : 208-377-4800 12554 WEST BRIDGER ST. SE DECISION MADE: 22-MAY-08 SUITE 108 510(k) STATEMENT BOISE, ID 83713 DEVICE: LAURIMED SPINAL INJECTION SYSTEM LAURIMED LLC 510(k) NO: K080140(TRADITIONAL)
ATTN: NANCY LINCE PHONE NO : 650-759-6186 500 ARGUELLO STREET, SUITE 100 SE DECISION MADE: 09-MAY-08 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM LB MEDICAL L.L.C. 510(k) NO: K080158(TRADITIONAL)
ATTN: TERRY SHERIDAN POWELL PHONE NO : 703-562-9800 901 KING STREET, SUITE 200 SE DECISION MADE: 02-MAY-08 ALEXANDRIA, VA 22314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LDR SPINE ROI-T IMPLANT LDR SPINE USA 510(k) NO: K080569(SPECIAL)
ATTN: NOAH BARTSCH PHONE NO : 512-344-3319 4030 WEST BRAKER LANE SE DECISION MADE: 07-MAY-08 SUITE 360 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78759 DEVICE: LDR SPINE ROI-C IMPLANT LDR SPINE USA 510(k) NO: K080728(SPECIAL)
ATTN: NOAH BARTSCH PHONE NO : 512-344-3319 4030 WEST BRAKER LANE SE DECISION MADE: 29-MAY-08 SUITE 360 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78759 DEVICE: LEICA FL800 LEICA MICROSYSTEMS (SCHWEIZ) AG 510(k) NO: K080612(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS SE DECISION MADE: 09-MAY-08 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLATEAU SPACER SYSTEM LIFE SPINE 510(k) NO: K080411(TRADITIONAL)
ATTN: REBECCA M BROOKS PHONE NO : 847-884-6117 2401 W. HASSELL RD. SE DECISION MADE: 15-MAY-08 SUITE 1535 510(k) SUMMARY AVAILABLE FROM FDA HOFFMAN ESTATES, IL 60169 DEVICE: CONQUEST SPINAL SYSTEM LIFE SPINE 510(k) NO: K080767(SPECIAL)
ATTN: REBECCA M BROOKS PHONE NO : 847-884-6117 2401 W. HASSELL RD. SE DECISION MADE: 21-MAY-08 SUITE 1535 510(k) SUMMARY AVAILABLE FROM FDA HOFFMAN ESTATES, IL 60169 DEVICE: LITEDUO LIGHT INSTRUMENTS 510(k) NO: K073411(TRADITIONAL)
ATTN: YORAM LEVY PHONE NO : 972 73 2442600 TAVOR BUILDING 1 SE DECISION MADE: 13-MAY-08 YOKNEAM IND. ZONE 510(k) SUMMARY AVAILABLE FROM FDA YOKNEAM ELETE, ISRAEL 20692 DEVICE: MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM MAKO SURGICAL CORP. 510(k) NO: K080029(TRADITIONAL)
ATTN: WILLIAM F TAPIA PHONE NO : 954-927-2044 2555 DAVIE RD., SUITE 110 SE DECISION MADE: 16-MAY-08 FT. LAUDERDALE, FL 33317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER MALLINCKRODT DEVELOPPEMENT FRANCE 510(k) NO: K080439(SPECIAL)
ATTN: TINA DREILING PHONE NO : 303-305-2512 6135 GUNBARELL AVE. SE DECISION MADE: 16-MAY-08 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTISTAR ELITE INJECTION SYSTEM MALLINCKRODT INC., LIEBEL-FLARSHEI510(k) NO: K073592(TRADITIONAL)
ATTN: DALE MOORE PHONE NO : 513-948-5771 2111 EAST GALBRAITH RD. SE DECISION MADE: 07-MAY-08 CINCINNATI, OH 45237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW S MASIMO CORPORATION 510(k) NO: K080238(TRADITIONAL)
ATTN: MARQUERITE THOMLINSON PHONE NO : 949-297-7258 40 PARKER SE DECISION MADE: 12-MAY-08 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100 MAX ENDOSCOPY INC. 510(k) NO: K080764(TRADITIONAL)
ATTN: RICHARD M WOLF PHONE NO : 330-425-7041 1410 HIGHLAND ROAD, SUITE 6 SE DECISION MADE: 06-MAY-08 MACEDONIA, OH 44056 510(k) STATEMENT DEVICE: SPINEASSIST SYSTEM MAZOR SURGICAL TECHNOLOGIES LTD. 510(k) NO: K073467(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 9 7670002 20 HATA'AS ST. SE DECISION MADE: 23-MAY-08 KFAR SABA, ISRAEL 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERISUITE 1.6, VERISUITE-PARTICLE 1.6 MEDCOM GMBH 510(k) NO: K080742(TRADITIONAL)
ATTN: STEFAN WALTER PHONE NO : 49 615 19514717 RUNDETURMSTR. 12 SE DECISION MADE: 09-MAY-08 DARMSTADT, HESSEN, GERMANY 64283 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 MEDI-PHYSICS, INC., DBA GE HEALTHC510(k) NO: K081066(SPECIAL)
ATTN: DAVID RISLEY PHONE NO : 609-514-6489 101 CARNEGIE CENTRE SE DECISION MADE: 05-MAY-08 PRINCETON, NJ 08540-6231 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDIAID M960 SERIES, VITAL SIGNS MONITOR AND MEDIAID M900 SERIES MEDIAID INC. 510(k) NO: K071642(TRADITIONAL)
ATTN: JAYESH PATEL PHONE NO : 714-367-2848 17517 FABRICA WAY, SUITE H SE DECISION MADE: 02-MAY-08 CERRITOS, CA 90703 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA MEDICATECH USA 510(k) NO: K080582(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 PO BOX 7007 SE DECISION MADE: 15-MAY-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSO MEDRAD, INC. 510(k) NO: K073051(ABBREVIATED)
ATTN: LESLIE S O'NAN PHONE NO : 412-767-2400 ONE MEDRAD DR. SE DECISION MADE: 30-MAY-08 INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SUR MEDTRONIC INC. 510(k) NO: K080509(TRADITIONAL)
ATTN: PREETI JAIN PHONE NO : 763-391-9533 7601 NORTHLAND DRIVE SE DECISION MADE: 05-MAY-08 MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-CONSOLE 560 MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K080824(TRADITIONAL)
ATTN: PREETI JAIN PHONE NO : 763-391-9533 7611 NORTHLAND DR. SE DECISION MADE: 07-MAY-08 MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROGENIX DBM PUTTY MEDTRONIC SOFAMOR DANEK 510(k) NO: K080462(TRADITIONAL)
ATTN: MICHELLE OBENAUER PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 13-MAY-08 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEEK PREVAIL CERVICAL INTERBODY DEVICE MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K073285(TRADITIONAL)
ATTN: MICHAEL SCOTT PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 15-MAY-08 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS MEDTRONIC XOMED, INC. 510(k) NO: K080257(TRADITIONAL)
ATTN: JAYME WILSON PHONE NO : 904-296-9600 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 22-MAY-08 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM MERETE MEDICAL GMBH 510(k) NO: K072251(TRADITIONAL)
ATTN: DONNA COLEMAN PHONE NO : 914-967-1532 49 PURCHASE STREET SE DECISION MADE: 08-MAY-08 RYE, NY 10580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLE MERZ DENTAL GMBH 510(k) NO: K080556(TRADITIONAL)
ATTN: RICHARD G HUNTER, M.S., RAC PHONE NO : 505-400-4992 5616 MARIOLA P1 NE SE DECISION MADE: 02-MAY-08 ALBUQURQUE, NM 87111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EAR THERMOMETER, MODELS ST66 AND ST67 MESURE TECHNOLOGY CO.,LTD. 510(k) NO: K080981(SPECIAL)
ATTN: JOHN CHEN PHONE NO : 886 2 85122747 7F,86, SEC.1,KWANG FU ROAD SE DECISION MADE: 02-MAY-08 SANCHUNG CITY, TAIPEI HSIEN, CHINA510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHRYSALIS META IMAGING SOLUTIONS, LLC 510(k) NO: K080655(TRADITIONAL)
ATTN: ROBERT J STAAB PHONE NO : 860-434-5872 30 NECK RD. SE DECISION MADE: 09-MAY-08 OLD LYME, CT 06371 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MO MICROLIFE CORP. 510(k) NO: K080337(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825 55 NORTHERN BLVD. SE DECISION MADE: 13-MAY-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: MICRUS MICROCOIL SYSTEM, "DELTAPAQ 10 CERECYTE", MODEL CDF MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K080437(TRADITIONAL)
ATTN: PATRICK LEE PHONE NO : 408-433-1400 821 FOX LANE SE DECISION MADE: 08-MAY-08 SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MPS ACACIA ENTERAL FEEDING TUBE MPS ACACIA 510(k) NO: K080328(TRADITIONAL)
ATTN: FERGIE FERGUSON PHONE NO : 714-257-0470 785 CHALLENGER ST. SE DECISION MADE: 14-MAY-08 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHUNTCHECK - CSF SHUNT FLOW DETECTOR NEURO DIAGNOSTIC DEVICES 510(k) NO: K080168(TRADITIONAL)
ATTN: FREDERICK J FRITZ PHONE NO : 215-645-0090 ONE NESHAMAMINY INTERPLEX SE DECISION MADE: 16-MAY-08 SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA TREVOSE, PA 19053 DEVICE: OPHTHALMOSCOPE F-10 NIDEK CO., LTD. 510(k) NO: K072259(ABBREVIATED)
ATTN: PAUL SUMNER PHONE NO : 770-448-3481 1733 CANTON LANE SE DECISION MADE: 06-MAY-08 MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV NIHON SEIMITSU SOKKI CO., LTD. 510(k) NO: K080177(TRADITIONAL)
ATTN: KOJI KOBO PHONE NO : 81 42 5481253 3F, 2-17-6 AKEBONO-CHO SE DECISION MADE: 09-MAY-08 TACHIKAWA- SHI, JAPAN 190-0012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER NONIN MEDICAL, INC. 510(k) NO: K080255(SPECIAL)
ATTN: LORI M ROTH PHONE NO : 763-577-3093 13700 1ST AVE. NORTH SE DECISION MADE: 23-MAY-08 PLYMOUTH, MN 55441-5443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORAS MR-BI320-PA 1.5T NORAS MRI PRODUCTS GMBH 510(k) NO: K081118(TRADITIONAL)
ATTN: MARTIN HEMPEL PHONE NO : 49 931 2992729 LEIBNITZSTRASSE 4 SE DECISION MADE: 02-MAY-08 HOECHBERG, GERMANY 97204 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FMRI HARDWARE SYSTEM NORDICNEUROLAB 510(k) NO: K080515(TRADITIONAL)
ATTN: STIAN SCISLY SAGEVIK PHONE NO : 47 95 203787 MOLLENDALSVEIEN 65C SE DECISION MADE: 16-MAY-08 BERGEN, NORWAY N-5009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUTROPHASE NOVABAY PHARMACEUTICALS 510(k) NO: K081009(TRADITIONAL)
ATTN: SHEILA W PICKERING PHONE NO : 510-899-8852 5980 HORTON ST. SUITE 550 SE DECISION MADE: 20-MAY-08 EMERYVILLE, CA 94608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT NOVABONE PRODUCTS, LLC 510(k) NO: K080009(TRADITIONAL)
ATTN: DAVID M GAISSER PHONE NO : 386-462-7660 13709 PROGRESS BLVD., #33 SE DECISION MADE: 06-MAY-08 ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SE NUCLETRON CORPORATION 510(k) NO: K080934(TRADITIONAL)
ATTN: LISA DIMMICK PHONE NO : 443-545-2196 8671 ROBERT FULTON DR. SE DECISION MADE: 28-MAY-08 COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) NUCLETRON CORPORATION 510(k) NO: K081281(TRADITIONAL)
ATTN: LISA DIMMICK PHONE NO : 410-312-4435 8671 ROBERT FULTON DR. SE DECISION MADE: 20-MAY-08 COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: I-MINI DENTAL IMPLANT OCO BIOMEDICAL 510(k) NO: K080115(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-254-5756 21525 RIDGETOP CIRCLE SE DECISION MADE: 30-MAY-08 SUITE 240 510(k) SUMMARY AVAILABLE FROM FDA STERLING, VA 20166 DEVICE: MOBLVAC W.C. OHIO MEDICAL CORPORATION 510(k) NO: K081185(SPECIAL)
ATTN: DAVID PLATT PHONE NO : 847-855-6272 1111 LAKESIDE DR. SE DECISION MADE: 02-MAY-08 GURNEE, IL 60031 510(k) STATEMENT DEVICE: OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS OLSEN MEDICAL 510(k) NO: K080187(TRADITIONAL)
ATTN: JOHN P WATERS PHONE NO : 502-772-4272 3001 WEST KENTUCKY ST. SE DECISION MADE: 09-MAY-08 LOUISVILLE, KY 40211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XTJF TYPE Q160VF1 OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K080403(TRADITIONAL)
ATTN: LAURA STORM-TYLER PHONE NO : 484-896-5688 3500 CORPORATE PARKWAY SE DECISION MADE: 20-MAY-08 PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA CENTER VALLEY, PA 18034-0610 DEVICE: OLYMPUS XCHF TYPE B180Y1 OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K080586(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 484-896-5688 3500 CORPORATE PARKWAY SE DECISION MADE: 06-MAY-08 PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA CENTER VALLEY, PA 18034-0610 DEVICE: OSFERION OLYMPUS TERUMO BIOMATERIALS CORPOR510(k) NO: K080065(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 484-896-5688 3500 CORPORATE PARKWAY SE DECISION MADE: 02-MAY-08 PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA CENTER VALLEY, PA 18034-0610 DEVICE: APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] OMNI LIFE SCIENCE, INC. 510(k) NO: K080842(SPECIAL)
ATTN: WILLIAM MCCALLUM PHONE NO : 508-824-2444 175 PARAMOUNT DRIVE SE DECISION MADE: 23-MAY-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT ONCOBIONICS, INC. 510(k) NO: K080202(SPECIAL)
ATTN: PAUL MIKUS PHONE NO : 949-888-6658 30211 AVENIDA DE LAS BANDERAS SE DECISION MADE: 08-MAY-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA RANCHO SANTA MARGARITA, CA 92679 DEVICE: CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLI ORAL HEALTH TECHNOLOGIES, LLC 510(k) NO: K080631(TRADITIONAL)
ATTN: ROBERT E TRICCA PHONE NO : 925-323-4284 1062 ALLEGHENY DRIVE SE DECISION MADE: 23-MAY-08 DANVILLE, CA 94526 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE ORE-MEDIX, LLC 510(k) NO: K080648(TRADITIONAL)
ATTN: DONALD F GRABARZ PHONE NO : 801-233-0075 7651 S. 700 WEST, SUITE 105 SE DECISION MADE: 07-MAY-08 MIDVALE, UT 84047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOMED MODULAR LOCKING FIXATION SYSTEM OSTEOMED L.P. 510(k) NO: K080694(TRADITIONAL)
ATTN: PIEDAD PENA PHONE NO : 972-677-4600 3885 ARAPAHO RD. SE DECISION MADE: 15-MAY-08 ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINI OSYPKA MEDICAL, INC. 510(k) NO: K081035(SPECIAL)
ATTN: MARKUS OSYPKA PHONE NO : 858-454-0021 7855 IVANHOE AVE., SUITE 226 SE DECISION MADE: 30-MAY-08 LA JOLLA, CA 92037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K080654(TRADITIONAL)
ATTN: CHRISTIAN QUASS PHONE NO : 49 770 49291586 KARL-HALL-STRASSE 01 SE DECISION MADE: 08-MAY-08 GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K080674(TRADITIONAL)
ATTN: CHRISTIAN QUASS PHONE NO : 49 770 49291586 KARL-HALL-STRASSE 01 SE DECISION MADE: 09-MAY-08 GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALOMAR ASPIRE LASER PLATFORM PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K081416(TRADITIONAL)
ATTN: SHARON TIMBERLAKE PHONE NO : 781-993-2414 82 CAMBRIDGE ST. SE DECISION MADE: 29-MAY-08 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DSS STABILIZATION SYSTEM PARADIGM SPINE 510(k) NO: K080963(SPECIAL)
ATTN: JUSTIN EGGLETON PHONE NO : 202-552-5800 1331 H STREET NW SE DECISION MADE: 02-MAY-08 12TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: MROPEN PARAMED SRL 510(k) NO: K073362(TRADITIONAL)
ATTN: MICHAEL A DOUGLAS PHONE NO : 978-975-7530 39 HIGH STREET SE DECISION MADE: 23-MAY-08 NORTH ANDOVER, MA 01845 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DURAFINISH ALL-CURE, MODEL S296 PARKELL, INC. 510(k) NO: K080549(TRADITIONAL)
ATTN: DANIEL R SCHECHTER, ESQ PHONE NO : 631-249-1134 300 EXECUTIVE DR. SE DECISION MADE: 13-MAY-08 EDGEWOOD, NY 11717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED PATTON SURGICAL CORP. 510(k) NO: K080161(TRADITIONAL)
ATTN: MICHAEL PATTON PHONE NO : 512-329-0469 6300 BRIDGEPOINT PKWY. SE DECISION MADE: 29-MAY-08 BLDG. 2, STE. 420 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78730 DEVICE: POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION PERUSAHAAN PELINDUNG GETAH (M) SDN510(k) NO: K072300(TRADITIONAL)
ATTN: THOMAS N TILLOTSON PHONE NO : 603-255-3791 2000 COLD SPRING ROAD SE DECISION MADE: 16-MAY-08 DIXVILLE NOTCH, NH 03576 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: PAGEWRITER CARDIOGRAPH PHILIPS MEDICAL SYSTEMS 510(k) NO: K080999(SPECIAL)
ATTN: PAUL SCHRADER PHONE NO : 978-659-2404 3000 MINUTEMAN RD. SE DECISION MADE: 09-MAY-08 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEA PHILIPS MEDIZIN SYSTEME BOEBLINGEN510(k) NO: K081203(SPECIAL) ATTN: MICHAEL ASMALSKY PHONE NO : 49 703 14631277 HEWLETT-PACKARD STR. 2 SE DECISION MADE: 28-MAY-08 BOEBLINGEN 510(k) SUMMARY AVAILABLE FROM FDA BADEN-WUERTTEMBERG, GERMANY D-71034 DEVICE: PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS PHOTONOVA OFSWEDEN AB 510(k) NO: K073477(TRADITIONAL)
ATTN: CONNIE HOY PHONE NO : 530-908-4903 908 STETSON STREET SE DECISION MADE: 09-MAY-08 WOODLAND, CA 95776 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM PIONEER SURGICAL TECHNOLOGY 510(k) NO: K073177(ABBREVIATED)
ATTN: JONATHAN M GILBERT PHONE NO : 906-226-4812 375 RIVER PARK CIRCLE SE DECISION MADE: 13-MAY-08 MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PLATINUM GLOVE INDUSTRIES SDN.BHD.510(k) NO: K080165(TRADITIONAL)
ATTN: SO SOON CHEAW PHONE NO : 603 334 18735 18-22-2 JALAN SETIA PRIMA (Q) SE DECISION MADE: 14-MAY-08 U13/Q, SETIA ALAM U13 510(k) STATEMENT SHAH ALAM, SELANGOR, MALAYSIA 40170 DEVICE: MODIFICATION TO PROFLU+ ASSAY PRODESSE, INC. 510(k) NO: K081030(SPECIAL)
ATTN: KAREN HARRINGTON PHONE NO : 262-446-0700 W229 N 1870 WESTWOOD DR. SE DECISION MADE: 02-MAY-08 WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE PT. SHAMROCK MANUFACTURING CORP. 510(k) NO: K081040(TRADITIONAL)
ATTN: EMMY TJOENG PHONE NO : 909-591-8855 5445 DANIELS ST. SE DECISION MADE: 20-MAY-08 CHINO, CA 91710 510(k) STATEMENT DEVICE: PULMODYNE CHF FLOW GENERATOR SYSTEM PULMODYNE 510(k) NO: K080256(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155 24301 WOODSAGE DRIVE SE DECISION MADE: 09-MAY-08 BONITA SPRINGS, FL 33134-2958 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROCHEM INDICATOR TAPE RAVEN LABORATORIES 510(k) NO: K080307(TRADITIONAL)
ATTN: WENDY ROYALTY-HANN PHONE NO : 402-593-0781 8607 PARK DR. SE DECISION MADE: 01-MAY-08 OMAHA, NE 68127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELEXOMA MEDIC REDPLANE AG 510(k) NO: K070412(TRADITIONAL)
ATTN: JAEN LABUSCHAGNE PHONE NO : 414 171 10365 BAARERSTRASSE 8 SE DECISION MADE: 21-MAY-08 ZUG, SWITZERLAND 6300 510(k) STATEMENT DEVICE: REVERA WOUND CARE, MODEL MDW0060 REVALESIO CORPORATION 510(k) NO: K070463(TRADITIONAL)
ATTN: GREG J ARCHAMBEAU PHONE NO : 253-922-2600 5102 20TH STREET EAST SE DECISION MADE: 07-MAY-08 BUILDING 100 510(k) SUMMARY AVAILABLE FROM FDA TACOMA, WA 98424 DEVICE: 3 CCD ENDOCAM 5550 RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K080977(TRADITIONAL)
ATTN: NIELS SCHMIDT PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 14-MAY-08 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AN RIO FLEXON TECHNOLOGY CO., LTD. 510(k) NO: K081256(TRADITIONAL)
ATTN: CHI-HUNG LIAO PHONE NO : 886 2 82218199 15F,868-2, JHONG JHENG RD., SE DECISION MADE: 27-MAY-08 JHONGHE CITY TAIPEI COUNTY, CHINA 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM ROCHE DIAGNOSTICS CORP. 510(k) NO: K080227(ABBREVIATED)
ATTN: SCOTT THIEL PHONE NO : 317-521-3362 9115 HAGUE RD. SE DECISION MADE: 15-MAY-08 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL ROCHE DIAGNOSTICS CORP. 510(k) NO: K080607(TRADITIONAL)
ATTN: KATHIE J CUNNINGHAM PHONE NO : 317-521-3831 9115 HAGUE RD. SE DECISION MADE: 12-MAY-08 P.O. BOX 50416 510(k) STATEMENT INDIANAPOLIS, IN 46250-3831 DEVICE: INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) RSB SPINE LLC. 510(k) NO: K081194(SPECIAL)
ATTN: KAREN E WARDEN PHONE NO : 440-729-8457 8202 SHERMAN ROAD SE DECISION MADE: 29-MAY-08 CHESTERLAND, OH 44026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTO-BAND LIGATOR SCANDIMED INTERNATIONAL 510(k) NO: K081142(SPECIAL)
ATTN: SALAH CHAMI PHONE NO : 011 454 4926444 409 SLOTSHERRENSVEJ SE DECISION MADE: 16-MAY-08 GLOSTROP, DENMARK DK 2600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCIENT'X TRIBECA VBR SCIENT'X USA, INC. 510(k) NO: K080588(TRADITIONAL)
ATTN: JOHN SANDERS PHONE NO : 407-571-2550 1015 MAITLAND CENTER COMMONS SE DECISION MADE: 30-MAY-08 SUITE 106A 510(k) SUMMARY AVAILABLE FROM FDA MAITLAND, FL 32751 DEVICE: GENESIS ECP SCOTTCARE CORPORATION 510(k) NO: K081359(SPECIAL)
ATTN: RONALD J CLINES PHONE NO : 216-362-0550 4791 WEST 150TH ST. SE DECISION MADE: 29-MAY-08 CLEVELAND, OH 44135 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY SENORX, INC. 510(k) NO: K081079(TRADITIONAL)
ATTN: EBEN GORDON PHONE NO : 949-362-4800 11 COLUMBIA SE DECISION MADE: 02-MAY-08 ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PROSTATE TISSUE MARKER SENORX, INC. 510(k) NO: K081170(TRADITIONAL)
ATTN: EBEN GORDON PHONE NO : 949-362-4800 11 COLUMBIA SE DECISION MADE: 28-MAY-08 ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 SERIM RESEARCH CORP. 510(k) NO: K080712(TRADITIONAL)
ATTN: PATRICIA RUPCHOCK PHONE NO : 574-264-3440 23565 REEDY DR. SE DECISION MADE: 06-MAY-08 ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM SHANTOU INSTITUTE OF ULTRASONIC IN510(k) NO: K081110(SPECIAL)
ATTN: BOB LEIKER PHONE NO : 925-556-1302 7263 CRONIN CIRCLE SE DECISION MADE: 16-MAY-08 DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL SHEFFIELD INDUSTRIES, DIV. OF FARI510(k) NO: K073684(TRADITIONAL)
ATTN: KATHLEEN HACKU PHONE NO : 860-442-4451 170 BROAD ST. SE DECISION MADE: 22-MAY-08 NEW LONDON, CT 06320 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,20 SHENZHEN ANT HI-TECH INDUSTRIAL CO510(k) NO: K072696(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467 SUITE 8D, ZHONGXIN ZHONGSHAN SE DECISION MADE: 02-MAY-08 NO.19, LANE 999 ZHONGSHAN NO.2 510(k) SUMMARY AVAILABLE FROM FDA SHANGHAI, CHINA 200030 DEVICE: DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K081320(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 27-MAY-08 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG PROSPEROUS PLASTIC CO510(k) NO: K073192(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 RM 1606 BLDG 1, JIANXIANG YUAN SE DECISION MADE: 02-MAY-08 NO 209 BEI SI HUAN ZHONG ROA 510(k) SUMMARY AVAILABLE FROM FDA BEIJING, CHINA 10083 DEVICE: SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION SHIMADZU CORP. 510(k) NO: K080701(ABBREVIATED)
ATTN: DON KARLE PHONE NO : 310-217-8855 20101 SOUTH VERMONT AVE. SE DECISION MADE: 14-MAY-08 TORRANCE, CA 90502-1328 510(k) STATEMENT DEVICE: SIALO BALLOON DILATATION CATHETER SIALO TECHNOLOGY, LTD. 510(k) NO: K072749(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 976 70002 20 HATA'AS ST. SE DECISION MADE: 14-MAY-08 KFAR SABA, ISRAEL 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K080578(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376 PO BOX 6101 SE DECISION MADE: 16-MAY-08 MAILBOX 514 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WIT SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K081074(SPECIAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626 PO BOX 6101 SE DECISION MADE: 23-MAY-08 MAILBOX 514 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: LOCI THYROID CALIBRATOR WITH MODEL RC610 SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K081103(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626 PO BOX 6101 SE DECISION MADE: 23-MAY-08 MAILBOX 514 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: SMITH & NEPHEW INSTRUMENT TRAYS SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K073551(ABBREVIATED)
ATTN: JULIE ACKER PHONE NO : 508-261-3618 130 FORBES BLVD. SE DECISION MADE: 21-MAY-08 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHELON TITANIUM HIP SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K072817(TRADITIONAL)
ATTN: MARLON D RIDLEY PHONE NO : 901-399-6055 1450 BROOKS RD. SE DECISION MADE: 15-MAY-08 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW MIS HIP STEM WITH STIKTITE SMITH & NEPHEW, INC. 510(k) NO: K080625(SPECIAL)
ATTN: RISHI SINHA PHONE NO : 901-399-6054 1450 BROOKS RD. SE DECISION MADE: 08-MAY-08 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM SNAP LABORATORIES, L.L.C. 510(k) NO: K080321(SPECIAL)
ATTN: GIL RAVIV PHONE NO : 847-777-0000 5210 CAPITOL DRIVE SE DECISION MADE: 23-MAY-08 WHEELING, IL 60090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOCA 180/195 WOUND CARE SYSTEM SOERING GMBH 510(k) NO: K072904(TRADITIONAL)
ATTN: CARL THOMAS PHONE NO : 940-300-8601 1600 MANCHESTER WAY SE DECISION MADE: 21-MAY-08 CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARIETEX PROGRIP MESH SOFRADIM PRODUCTION 510(k) NO: K081050(TRADITIONAL)
ATTN: SHARON ALEXANDER PHONE NO : 203-492-6060 60 MIDDLETOWN AVENUE SE DECISION MADE: 28-MAY-08 NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C SOMANETICS CORP. 510(k) NO: K080769(TRADITIONAL)
ATTN: RONALD A WIDMAN PHONE NO : 248-689-3050 1653 EAST MAPLE RD. SE DECISION MADE: 14-MAY-08 TROY, MI 48083-4208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPRASORB A +AG SPECIALTY FIBRES AND MATERIALS LTD510(k) NO: K071442(TRADITIONAL)
ATTN: COLIN LUDFORD PHONE NO : 011 442 476708210 101, LOCKHURST LN. SE DECISION MADE: 01-MAY-08 COVENTRY, UNITED KINGDOM CV6 5RS 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINAL USA INTERBODY FUSION DEVICE SPINAL USA 510(k) NO: K080314(TRADITIONAL)
ATTN: JEFFREY JOHNSON PHONE NO : 601-420-4244 644 LAKELAND EAST DR., STE. A SE DECISION MADE: 13-MAY-08 FLOWOOD, MS 39232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPSURE PS (R) SPINE SYSTEM SPINE WAVE, INC. 510(k) NO: K081228(SPECIAL)
ATTN: ROAIDA RIZKALLAH PHONE NO : 203-944-9494 TWO ENTERPRISE DR. SE DECISION MADE: 12-MAY-08 SUITE 302 510(k) SUMMARY AVAILABLE FROM FDA SHELTON, CT 06484 DEVICE: SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE SPIRUS MEDICAL, INC. 510(k) NO: K080050(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVENUE SE DECISION MADE: 06-MAY-08 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT SSL AMERICAS 510(k) NO: K072236(TRADITIONAL)
ATTN: CHRIS ROBINSON PHONE NO : 770-582-2174 3585 ENGINEERING DR. SE DECISION MADE: 07-MAY-08 NORCROSS, GA 30092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STD MED PRIMO PORT POLY STD MED, INC. 510(k) NO: K080645(SPECIAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVENUE SE DECISION MADE: 02-MAY-08 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STE STERIS CORPORATION 510(k) NO: K073244(TRADITIONAL)
ATTN: JOHN R SCOVILLE PHONE NO : 440-392-7330 5960 HEISLEY RD. SE DECISION MADE: 28-MAY-08 MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR STERIS CORPORATION 510(k) NO: K080750(TRADITIONAL)
ATTN: JOHN SCOVILLE PHONE NO : 440-392-7330 5960 HEISLEY RD. SE DECISION MADE: 12-MAY-08 MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL STRYKER GI 510(k) NO: K081004(SPECIAL)
ATTN: TIFFANI ROGERS PHONE NO : 972-410-7313 1420 LAKESIDE PARKWAY, #110 SE DECISION MADE: 02-MAY-08 FLOWER MOUND, TX 75028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DR SUNLIGHT MEDICAL, INC. 510(k) NO: K072600(TRADITIONAL) ATTN: DUNSONG YANG PHONE NO : 904-866-7978 12443 SAN JOSE BLVD. SE DECISION MADE: 19-MAY-08 SUITE 602 510(k) SUMMARY AVAILABLE FROM FDA JACKSONVILLE, FL 32223 DEVICE: SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC A SYNERGEYES, INC. 510(k) NO: K081034(ABBREVIATED)
ATTN: RICHARD E LIPPMAN PHONE NO : 240-683-3738 15825 SHADY GROVE ROAD SE DECISION MADE: 30-MAY-08 SUITE 30 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20850 DEVICE: SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM SYNTHES (USA) 510(k) NO: K080153(TRADITIONAL)
ATTN: ANDREA M TASKER PHONE NO : 610-719-6920 1301 GOSHEN PKWY SE DECISION MADE: 14-MAY-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES SYNTHES (USA) 510(k) NO: K080522(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-6940 1301 GOSHEN PKWY SE DECISION MADE: 23-MAY-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES 6.5MM MIDFOOT FUSION BOLT SYNTHES (USA) 510(k) NO: K081071(TRADITIONAL)
ATTN: KARL J NITTINGER PHONE NO : 610-719-6941 1301 GOSHEN PKWY SE DECISION MADE: 01-MAY-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCOFIX SYNTHES SPINE CO.LP 510(k) NO: K080020(TRADITIONAL)
ATTN: KIRSTEN STOWELL PHONE NO : 610-719-5534 1302 WRIGHTS LANE EAST SE DECISION MADE: 23-MAY-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYS SYSMEX AMERICA, INC. 510(k) NO: K080887(SPECIAL)
ATTN: NINA GAMPERLING PHONE NO : 847-996-4675 ONE NELSON C. WHITE PARKWAY SE DECISION MADE: 02-MAY-08 MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASY GRIP DENTAL IMPLANT SYSTEM T.F.I. SYSTEM S.R.L 510(k) NO: K073622(TRADITIONAL)
ATTN: DOTT. CLAUDIO MECHELLI PHONE NO : 390 687 201371 VIA ALESSANDRO D'ANCONA 23 SE DECISION MADE: 14-MAY-08 ROMA (RM), ITALY 00137 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM TAKIRON CO., LTD 510(k) NO: K073006(TRADITIONAL)
ATTN: KUNIHIRO HATA PHONE NO : 81 783 062601 7-1-19, MINATOJIMAMINAMIMACHI, SE DECISION MADE: 29-MAY-08 CHUO-KU, KOBE, HYOGO, JAPAN 650-00510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOTRANS-OT PIN TAKIRON CO., LTD 510(k) NO: K073311(TRADITIONAL)
ATTN: KUMIHIRO HATA PHONE NO : 81 78 3062601 7-1-19, MINATOJIMAMINAMIMACHI, SE DECISION MADE: 13-MAY-08 CHUO-KU, KOBE, HYOGO, JAPAN 650-00510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOTRANS-OT SCREW TAKIRON CO., LTD 510(k) NO: K073312(TRADITIONAL)
ATTN: KUNIHIRO HATA PHONE NO : 81 78 3062601 7-1-19, MINATOJIMAMINAMIMACHI, SE DECISION MADE: 13-MAY-08 CHUO-KU, KOBE, HYOGO, JAPAN 650-00510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG TALLEY MEDICAL 510(k) NO: K080763(TRADITIONAL)
ATTN: JACK VAN DYKE PHONE NO : 517-290-0089 1070 E. WIELAND RD. SE DECISION MADE: 30-MAY-08 LANSING, MI 48906 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) TANGSHAN HONGYUN PLASTIC PRODUCTS 510(k) NO: K071999(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606 BLDG. 1, SE DECISION MADE: 08-MAY-08 JIANZIANG YUAN NO 209 BEI SI 510(k) SUMMARY AVAILABLE FROM FDA HUAN ZHONG, ROA; BEIJING, CHINA 10008 DEVICE: TARRY MEDICAL TEMPERATURE PROBES TARRY MEDICAL PRODUCTS, INC. 510(k) NO: K071977(TRADITIONAL)
ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320 543 LONG HILL AVENUE SE DECISION MADE: 23-MAY-08 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES TECHNOMED EUROPE 510(k) NO: K073532(TRADITIONAL)
ATTN: MAURICE ROOST PHONE NO : 314 340 86868 AMERIKALAAN 71 SE DECISION MADE: 01-MAY-08 MAASTRICHT AIRPORT, NETHERLANDS 61510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TC MATRIX CLINICAL CHEMISTRY ANALYZER TECO DIAGNOSTICS 510(k) NO: K073370(TRADITIONAL)
ATTN: JIM VAECHHES PHONE NO : 714-693-7788 1268 NORTH LAKEVIEW AVE. SE DECISION MADE: 08-MAY-08 ANAHEIM, CA 92807 510(k) STATEMENT DEVICE: SPACER-G TEMPORARY HIP PROSTHESIS TECRES SPA 510(k) NO: K062273(TRADITIONAL)
ATTN: AMNON TALMOR PHONE NO : 352-377-1140 2320 N.W. 66TH COURT SE DECISION MADE: 22-MAY-08 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, TECRES SPA 510(k) NO: K062274(TRADITIONAL)
ATTN: DIANA TAYLOR PHONE NO : 352-377-1140 2320 N.W. 66TH COURT SE DECISION MADE: 22-MAY-08 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DESTINATION RENAL GUIDING SHEATH TERUMO MEDICAL CORP. 510(k) NO: K081045(SPECIAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7213 950 ELKTON BLVD. SE DECISION MADE: 28-MAY-08 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH TERUMO MEDICAL CORP. 510(k) NO: K081046(SPECIAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7213 950 ELKTON BLVD. SE DECISION MADE: 21-MAY-08 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UREA/BUN, SCAL, NORTROL, ABTROL THERMO FISHER SCIENTIFIC OY 510(k) NO: K073295(TRADITIONAL)
ATTN: PAIVI SORMUNEN PHONE NO : 358 932 9100 2 RATASTIE SE DECISION MADE: 29-MAY-08 VANTAA, FINLAND 01620 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: URIC ACID (AOX), SCAL, NORTROL, ABTROL THERMO FISHER SCIENTIFIC OY 510(k) NO: K073612(TRADITIONAL)
ATTN: PAIVI SORMUNEN PHONE NO : 358 9 32910762 2 RATASTIE SE DECISION MADE: 23-MAY-08 P.O. BOX 100 510(k) SUMMARY AVAILABLE FROM FDA VANTAA, FINLAND FIN-01621 DEVICE: REINFORCED CATHETER INTRODUCER SYSTEM (RCIS) THOMAS MEDICAL PRODUCTS, INC. 510(k) NO: K081341(TRADITIONAL)
ATTN: TIM STOUDT PHONE NO : 610-296-3000 65 GREAT VALLEY PKWY. SE DECISION MADE: 14-MAY-08 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: 19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A TOTOKU ELECTRIC CO., LTD 510(k) NO: K080951(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 812 683 45469 300 OYA SE DECISION MADE: 29-MAY-08 UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 15-INCH (38 CM) COLOR LCD MONITOR CDL1576A TOTOKU ELECTRIC CO., LTD 510(k) NO: K080952(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 812 683 45469 300 OYA SE DECISION MADE: 29-MAY-08 UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TSO3 OZONE STERILIZATION WRAP TSO3 INC. 510(k) NO: K080198(TRADITIONAL)
ATTN: CHARLES O HANCOCK PHONE NO : 585-223-1850 33 BLACK WATCH TRAIL SE DECISION MADE: 30-MAY-08 FAIRPORT, NY 14450 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TUTODENT DENTAL MEMBRANE TUTOGEN MEDICAL U.S., INC. 510(k) NO: K073097(TRADITIONAL)
ATTN: TRAVIS AROLA PHONE NO : 386-418-8888 13709 PROGRESS BLVD. SE DECISION MADE: 12-MAY-08 BOX 19 SOUTH WING 510(k) SUMMARY AVAILABLE FROM FDA ALACHUA, FL 32615 DEVICE: AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING U TYCO HEALTHCARE GROUP, LP 510(k) NO: K080898(TRADITIONAL)
ATTN: SHARON ALEXANDER PHONE NO : 203-492-6060 60 MIDDLETOWN AVE. SE DECISION MADE: 05-MAY-08 NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IV ADMINISTRATION SET U.S. SAFETY SYRINGES CO., INC. 510(k) NO: K080660(TRADITIONAL)
ATTN: CHRISTINE SMITH PHONE NO : 888-729-9674 1676 VILLAGE GREEN SE DECISION MADE: 13-MAY-08 CROFTON, MD 21114 510(k) STATEMENT THIRD PARTY REVIEW
DEVICE: NOVOLET U.S. SAFETY SYRINGES CO., INC. 510(k) NO: K080665(TRADITIONAL)
ATTN: CHRISTINA SMITH PHONE NO : 888-645-2795 1676 VILLAGE GREEN SE DECISION MADE: 13-MAY-08 CROFTON, MD 21114 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: WBR XPRESS3.CARDIAC ULTRASPECT LTD. 510(k) NO: K081201(SPECIAL)
ATTN: DAN LAOR PHONE NO : 972 482 46632 6 SIRENI SE DECISION MADE: 28-MAY-08 HAIFA, ISRAEL 32972 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEARTRAK AF UNIVERSAL MEDICAL, INC. 510(k) NO: K071130(ABBREVIATED)
ATTN: STEVEN ADAMSKY PHONE NO : 609-671-1790 275 PHILLIPS BLVD. SE DECISION MADE: 14-MAY-08 EWING, NJ 08618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC A UNIVERSITY OF UTAH HOSPITALS AND C510(k) NO: K080551(TRADITIONAL)
ATTN: BRENT ALM PHONE NO : 801-581-2847 50 NORTH MEDICAL DR. SE DECISION MADE: 28-MAY-08 SALT LAKE CITY, UT 84132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICAT VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K081036(SPECIAL)
ATTN: VY TRAN PHONE NO : 650-424-5731 3100 HANSEN WAY M/S E-110 SE DECISION MADE: 09-MAY-08 PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IVENT 2001 MRI CONDITIONAL VERSAMED MEDICAL SYSTEMS, INC. 510(k) NO: K073694(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155 3460 POINTE CREEK CT SE DECISION MADE: 30-MAY-08 SUITE 102 510(k) SUMMARY AVAILABLE FROM FDA BONITA SPRINGS, FL 34134-2015 DEVICE: VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM VISIONSENSE, LTD. 510(k) NO: K081102(TRADITIONAL)
ATTN: GERARD J PRUD'HOMME PHONE NO : 202-637-5735 555 13TH STREET, NW SE DECISION MADE: 29-MAY-08 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVOLUTION 45MHZ IVUS IMAGING CATHETER VOLCANO CORPORATION 510(k) NO: K080891(SPECIAL)
ATTN: JENNIFER MOTTO PHONE NO : 916-231-4509 2870 KILGORE RD. SE DECISION MADE: 12-MAY-08 RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAR MONITOR VORTRAN MEDICAL TECHNOLOGY 1, INC.510(k) NO: K073261(SPECIAL)
ATTN: JAMES LEE PHONE NO : 916-648-8460 21 GOLDEN LAND COURT SE DECISION MADE: 23-MAY-08 SACRAMENTO, CA 95834 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEPATOSTAT SET VYGON CORP. 510(k) NO: K073493(TRADITIONAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300 2495 GENERAL ARMISTEAD AVE SE DECISION MADE: 06-MAY-08 NORRISTOWN, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GORE INFINIT MESH W.L. GORE & ASSOCIATES,INC 510(k) NO: K081069(ABBREVIATED)
ATTN: MICHAEL J TITUS PHONE NO : 410-506-8125 301 AIRPORT RD. SE DECISION MADE: 30-MAY-08 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOYALA GEL VENTED WEINMANN GERATE FUR MEDIZIN GMBH +510(k) NO: K081014(SPECIAL)
ATTN: RALF EGENOLF PHONE NO : 011 49 4054702370 KRONSAALSWEG 40 SE DECISION MADE: 09-MAY-08 HAMBURG, GERMANY 22525 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFEMUR LX 5/8 COATED HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K081090(SPECIAL)
ATTN: RYAN ROSS PHONE NO : 901-867-4401 5677 AIRLINE RD. SE DECISION MADE: 15-MAY-08 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUBDERMAL NEEDLE ELECTRODES XIAN FRIENDSHIP ELECTRONICS CO.,LT510(k) NO: K072276(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 018 2387441 RM 1606 BLDG. 1, JIANXIANG YUA SE DECISION MADE: 16-MAY-08 NO. 229 BEI SI HUAN ZHONG RD. 510(k) SUMMARY AVAILABLE FROM FDA HAIDIAN DISTRICT, BEIJING, CHINA 100083 DEVICE: AXXENT VAGINAL APPLICATOR XOFT, INC. 510(k) NO: K072616(TRADITIONAL)
ATTN: ERIC HASHEMIAN PHONE NO : 510-580-2900 49000 MILMONT DRIVE SE DECISION MADE: 09-MAY-08 FREMONT, CA 94538-7301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STYLA MICROLASER AND STYLAORTHO ZAP LASERS, LLC 510(k) NO: K081214(TRADITIONAL)
ATTN: JAY GOBLE PHONE NO : 888-876-4546 2621 PLEASANT HILL RD. SE DECISION MADE: 14-MAY-08 PLEASANT HILL, CA 94523 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE ZELTIQ AESTHETICS 510(k) NO: K080118(TRADITIONAL)
ATTN: DONALD V JOHNSON PHONE NO : 925-474-2500 4698 WILLOW ROAD SE DECISION MADE: 02-MAY-08 PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM ZEUS SCIENTIFIC, INC. 510(k) NO: K072178(TRADITIONAL)
ATTN: EWA NADOLCZAK PHONE NO : 908-243-4924 200 EVANS WAY SE DECISION MADE: 30-MAY-08 BRANCHBURG, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLORISE RIGID ZHERMACK S.P.A. 510(k) NO: K081084(SPECIAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935 19379 BLUE LAKE LOOP SE DECISION MADE: 14-MAY-08 BEND, OR 97702 510(k) STATEMENT DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) ZIBO HONGYE SHANGQIN PLASTIC RUBBE510(k) NO: K072084(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 RM 1606 BLDG.1. JIANXIANG YUAN SE DECISION MADE: 08-MAY-08 NO 209 BEI SI HUAN ZHONG ROA 510(k) SUMMARY AVAILABLE FROM FDA BEIJING, CHINA 10083 DEVICE: ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM ZIMMER, INC. 510(k) NO: K081007(SPECIAL)
ATTN: BENJAMIN C CURSON PHONE NO : 574-372-4119 P.O. BOX 708 SE DECISION MADE: 06-MAY-08 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 278 TOTAL WITH SUMMARIES 256 TOTAL WITH STATEMENTS 22
Updated August 7, 2008
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