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Medical Devices
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May 2008 510(k) Clearances
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
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