FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K091632 |
09/03/2009 |
SPK SEALANT |
3M COMPANY |
SHARI MYSZKA |
K090718 |
09/21/2009 |
BELLUS SHADING KIT |
3M ESPE AG DENTAL PRODUCTS |
DESI W SOEGIARTO |
K091826 |
09/25/2009 |
ELEGANT |
3M ESPE AG DENTAL PRODUCTS |
DESI W SOEGIARTO |
K091825 |
09/25/2009 |
HI-TORQUE PROGRESS GUIDE WIRE FAMILY |
ABBOTT VASCULAR INC. |
MICHELE WALZ |
K091999 |
09/18/2009 |
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM |
ACCURAY, INC. |
ANNE SCHLAGENHAFT |
K092594 |
09/16/2009 |
ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX |
ACE SURGICAL SUPPLY CO., INC. |
J.EDWARD CARCHIDI |
K092393 |
09/01/2009 |
EK/P. AERUGINOSA PNA FISH |
ADVANDX, INC. |
PAULA E BULGER |
K092143 |
09/22/2009 |
EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM |
AESCULAP IMPLANT SYSTEMS, INC. |
KATHY A RACOSKY |
K092635 |
09/10/2009 |
ALCATEL-LUCENT TELEHEATH MANAGER |
ALCATEL-LUCENT CANADA INC. |
ALEX GIOSA |
K091544 |
09/09/2009 |
S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 |
ALFA WASSERMANN, INC. |
HYMAN KATZ |
K091930 |
09/23/2009 |
ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB |
ANCHOR PRODUCTS CO. |
GARY S THRUN |
K091619 |
09/08/2009 |
ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW) |
ANGLEFIX |
RICHARD JANSEN |
K092327 |
09/21/2009 |
MICRO-TOUCH NITRA FREE |
ANSELL HEALTHCARE PRODUCTS LLC |
CYNTHIA A INGRAM |
K091647 |
09/21/2009 |
INJECTAFIL |
APEX DENTAL MATERIALS, INC. |
CHRIS KULTON |
K091228 |
09/28/2009 |
SPINEWAND SURGICAL DEVICE |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
K091239 |
09/22/2009 |
ASTRA TECH IMPLANT SYSTEM |
ASTRA TECH AB |
LINDA K SCHULZ |
K091920 |
09/28/2009 |
ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL |
ASTRA TECH, INC. |
BETSY A BROWN |
K091406 |
09/04/2009 |
ATLAS SPINE SPACER |
ATLAS SPINE LLC |
JEANNETTE DAILEY |
K090117 |
09/29/2009 |
AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET |
AUTOSAFE-REFLEX INC. |
JOHN STEPHENS |
K083868 |
09/25/2009 |
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 |
AXIS-SHIELD DIAGNOSTICS, LTD. |
Claire Dora |
K091321 |
09/11/2009 |
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY |
BACTERIN INTERNATIONAL INC. |
HOWARD J SCHRAYER |
K091718 |
09/02/2009 |
NEUTRASAL |
BARTOR PHARMACAL CO., INC. |
EDWARD D KOBUS |
K092533 |
09/15/2009 |
FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES |
BEERE PRECISION MEDICAL INSTRUMENTS, KMEDIC, TELEF |
JOY VOIGT |
K090339 |
09/23/2009 |
BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2 |
BELIMED SAUTER AG |
CHRIS P MANNARINO |
K083744 |
09/01/2009 |
BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 |
BINAX, INC. |
Anne Jepson |
K091489 |
09/04/2009 |
CLEARVIEW ADVANCED STREP A , MODEL 737-430 |
BINAX, INC. |
ERIN E KENALEY |
K083536 |
09/11/2009 |
DENSICHEK PLUS |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
K091608 |
09/17/2009 |
COBALT MV BONE CEMENT |
BIOMET MANUFACTURING CORP. |
SUSAN ALEXANDER |
K090757 |
09/25/2009 |
BIOMET MODULAR FEMORAL REVISION SYSTEM |
BIOMET, INC. |
BECKY EARL |
K090898 |
09/04/2009 |
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER |
BIOSENSE WEBSTER, INC. |
NATALIE BENNINGTON |
K092624 |
09/25/2009 |
FIREBIRD SPINAL FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
WHITNEY G TORNING |
K082841 |
09/09/2009 |
SPINAL FORAMINOSCOPE |
BLAZEJEWSKI MEDI-TECH GMBH |
ANGELIKA SCHERP |
K090871 |
09/04/2009 |
CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12 |
BONESUPPORT AB |
ANN-CHRISTINE PROVOOST |
K083715 |
09/15/2009 |
BELTBEAT WF-400 |
BONUS COMMUNICACIONES SRL |
BENNY ARAZY |
K090175 |
09/10/2009 |
UNITY BETA PLLA SYSTEM |
BONUTTI RESEARCH, INC. |
PATRICK BALSMANN |
K091135 |
09/14/2009 |
RUTTER SUPRA STOMAL STENTS |
BOSTON MEDICAL PRODUCTS, INC. |
MICHAEL A WARREN |
K092666 |
09/30/2009 |
INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250 |
BOSTON SCIENTIFIC CORP. |
JAMES LEATHLEY |
K092455 |
09/04/2009 |
MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM |
Boston Scientific Corporation |
SHANNON PETIT |
K091841 |
09/02/2009 |
BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 |
BRIDGEPOINT MEDICAL |
JILL MUNSINGER |
K090496 |
09/01/2009 |
QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH |
CARDIAC LEAD TECHNOLOGIES, INC. |
CLAUDIA LEWIS-ENG |
K091943 |
09/10/2009 |
POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A |
CARDIAC SCIENCE CORPORATION |
BEVERLY MAGRANE |
K092304 |
09/15/2009 |
ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES |
CARDINAL HEALTH, INC. |
TATYANA BOGDAN |
K082118 |
09/18/2009 |
XPERT HEMOSIL FACTOR II & FACTOR V ASSAY |
CEPHEID |
RUSSEL K ENNS |
K091559 |
09/18/2009 |
MARKSMANN CATHETER |
CHESTNUT MEDICAL TECHNOLOGIES, INC. |
DANIEL CHER |
K091877 |
09/02/2009 |
CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL |
CHISON MEDICAL IMAGING CO., LTD. |
BOB LEIKER |
K083567 |
09/14/2009 |
GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW |
CO-LIGNE AG |
DAVID W SCHLERF |
K083783 |
09/11/2009 |
VF LIQUIGEL |
COAPT SYSTEMS, INC. |
LOUIS-PIERRE MARCOUX |
K091921 |
09/08/2009 |
CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP |
Codman & Shurtleff, Inc. |
PAUL AMARAL |
K090216 |
09/18/2009 |
COLLAGEN DENTAL MEMBRANE IV |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
K092132 |
09/24/2009 |
XIO RTP SYSTEM |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
KATHRYN STINSON |
K090193 |
09/25/2009 |
CONDUCTOR CORONARY GUIDEWIRE |
CONCERT MEDICAL, LLC |
PAMELA PAPINEAU |
K092441 |
09/09/2009 |
MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM |
CONFORMIS, INC. |
AMITA SHAH |
K090773 |
09/18/2009 |
CFI ULTRASOUND PROBE DRAPE |
CONTOUR FABRICATORS, INC. |
JOHN W SCHAEFER |
K090254 |
09/04/2009 |
SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. |
PATRICIA KEARINS |
K090183 |
09/25/2009 |
HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON |
COOK ENDOSCOPY |
TIFFANNY THOMAS |
K082939 |
09/03/2009 |
COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 |
COOK UROLOGICAL, INC. |
CINDY FOOTE |
K091637 |
09/29/2009 |
CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 |
CORPAK MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
K091223 |
09/11/2009 |
VALLEYLAB SUCTION COAGULATOR, MODEL E3305 |
COVIDIEN LP |
PHILIP AKE |
K091869 |
09/01/2009 |
SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS |
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
ROBERT ZOTT |
K091800 |
09/23/2009 |
LIPOEZE LASER ASSISTED ASPIRATION CANNULA |
CURVE MEDICAL |
F. DAVID ROTHKOPF |
K091537 |
09/03/2009 |
CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH |
CYNOSURE, INC. |
ANTHONY BURNS |
K092319 |
09/16/2009 |
STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 |
DANVILLE MATERIALS, INC. |
CRAIG BRUNS |
K090911 |
09/11/2009 |
IST SNORING APPLIANCE |
DENTAL CRAFTERS |
AMY NYSTROM |
K092626 |
09/25/2009 |
MODIFICATION TO: EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
FRANK JURCZAK |
K091171 |
09/11/2009 |
D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT |
DIAGNOSTIC HYBRIDS, INC. |
Ronald H Lollar |
K090104 |
09/09/2009 |
LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603 |
DIASORIN, INC. |
KELLY R SAUER |
K092130 |
09/21/2009 |
RASCAL WE GO 250 POWERED WHEELCHAIR |
ELECTRIC MOBILITY CORP. |
W. STEPHEN BEVERSLUIS |
K092083 |
09/22/2009 |
EXTEND FRAME SYSTEM, MODEL 1009633 |
ELEKTA INSTRUMENT AB |
ABDERS SKOGLUND |
K091350 |
09/15/2009 |
ESTECH HAWKEYE INTRODUCER SYSTEMS |
ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH |
TAMER IBRAHIM |
K090855 |
09/18/2009 |
EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE |
ETEX CORP. |
CHRISTOPHER KLACZYK |
K091211 |
09/04/2009 |
EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORS |
ETHICON ENDO-SUGERY, LLC |
ASIFA VONHOF |
K092577 |
09/15/2009 |
ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75) |
ETHICON ENDO-SURGERY, LLC |
Abhilasha Mukherjee |
K092495 |
09/22/2009 |
HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315 |
EV3 NEUROVASCULAR |
LAURIE E CARTWRIGHT |
K092562 |
09/18/2009 |
MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS |
FHC, INC. |
LEE D MARGOLIN |
K083428 |
09/01/2009 |
F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY |
FIAB SPA |
SILVIA CALABRO |
K081996 |
09/15/2009 |
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM |
FLEXIBLE STENTING SOLUTIONS, INC. |
JOSEPH C GRIFFIN |
K092629 |
09/25/2009 |
SNM FIRMGRIP |
FLEXICATH LTD. |
TALI HAZAN |
K091488 |
09/14/2009 |
FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C |
FOOTPRINT MEDICAL |
CLYDE BAKER |
K091214 |
09/25/2009 |
FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER |
FOOTPRINT MEDICAL |
CLYDE BAKER |
K091213 |
09/25/2009 |
FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN |
FOOTPRINT MEDICAL |
CLYDE BAKER |
K092645 |
09/05/2009 |
FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 |
FUJIREBIO DIAGNOSTICS, INC. |
JOHN GORMLEY |
K092189 |
09/18/2009 |
POGO SCREW |
FXDEVICES |
RICH LIPSCHUTZ |
K092020 |
09/29/2009 |
AADVA ZR COLORING LIQUID |
GC AMERICA INC. |
MARK HEISS |
K092680 |
09/23/2009 |
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN |
GE HEALTHCARE FINLAND OY |
RAUNO RUOHO |
K092756 |
09/28/2009 |
GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM |
GE VINGMED ULTRASOUND AS |
JAN T THOLLEFSEN |
K092576 |
09/04/2009 |
GEM HEART ONE/ONE+ |
GEM-MED S.L. |
WILSON TSENG |
K092633 |
09/25/2009 |
OSOM INFLUENZA A&B TEST , MODEL PN190 |
GENZYME CORPORATION |
FIL BUENVIAJE |
K090449 |
09/18/2009 |
MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT |
GISH BIOMEDICAL, INC. |
JANET PEETS |
K090450 |
09/18/2009 |
MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT |
GISH BIOMEDICAL, INC. |
JANET PEETS |
K090557 |
09/28/2009 |
GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM |
GIVEN IMAGING LTD. |
Tim Thomas |
K092851 |
09/29/2009 |
MODEL GDCH-2000 |
GLOBAL DENTAL DIRECT, INC. |
DON TEMPLE |
K092610 |
09/24/2009 |
MODIFICATION TO BEACON STABILIZATION SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
K092373 |
09/03/2009 |
ICS CHARTR EP 200 |
GN OTOMETRICS |
DANIEL KAMM |
K091359 |
09/02/2009 |
GSO PCT SPINAL SYSTEM |
GOLD STANDARD ORTHOPAEDICS, LLC |
DAVID BAUGHMAN |
K091187 |
09/14/2009 |
GRACE DYNAMIC TORP |
Grace Medical, Inc. |
JEFF COBB |
K092200 |
09/16/2009 |
POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED) |
GX CORPORATION SDN BHD |
FOO KHON PU |
K092278 |
09/29/2009 |
GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 |
GYRUS ACMI, INC. |
GRAHAM A.L. BAILLIE |
K083157 |
09/29/2009 |
HS AMICA |
H.S HOSPITAL SERVICE S.P.A. |
LUCIO IMPROTA |
K091808 |
09/10/2009 |
SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 |
HANSEN MEDICAL, INC. |
KATE WHITIN |
K091652 |
09/04/2009 |
NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS |
HARTALEGA SDN BHD |
NURUL AISYAH KONG BT ABDULLAH |
K092161 |
09/30/2009 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF |
HEALTH & LIFE CO., LTD. |
SARAH SU |
K091220 |
09/21/2009 |
HEALTHANYWHERE SYSTEM |
HEALTHANYWHERE, AN IGEACARE SYSTEM COMPANY |
SHAWN SLADE |
K092155 |
09/21/2009 |
HEARTWAY POWER MOBILITY SCOOTER, S8 |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
Ke-Min Jen |
K092154 |
09/21/2009 |
HEARTWAY POWER MOBILITY SCOOTER, S9 |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
Ke-Min Jen |
K091635 |
09/03/2009 |
VENUS DIAMOND FLOW |
HERAEUS KULZER, LLC |
CHERYL ZIMMERMAN |
K090652 |
09/25/2009 |
ALPHA DUO LAP INSUFFLATOR |
HIPPOKRATEC GMBH |
CHRISTIAN SIEDERSBERGER |
K091268 |
09/18/2009 |
HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS |
HOSPIRA, INC. |
DANIELA WEKSLER |
K092419 |
09/01/2009 |
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS |
HOWMEDICA OSTEONICS CORP. |
MELISSA A MATARESE |
K092671 |
09/23/2009 |
VARIAX ELBOW SYSTEM LINE EXTENSION |
HOWMEDICA OSTEONICS CORP. |
MELISSA A MATARESE |
K092018 |
09/18/2009 |
OMNIPRO INCLINE |
IBA DOSIMETRY GMBH |
CHUCK LINDLEY |
K091166 |
09/02/2009 |
IMRX |
IMRIS, INC. |
THOMAS M TSAKERIS |
K083378 |
09/29/2009 |
SYNERGY |
INNERSPACE, INC. |
DON BOBO |
K083288 |
09/03/2009 |
DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER |
INNOVA VISION INC. |
JENNIFER REICH |
K092715 |
09/28/2009 |
IROOT BP PLUS |
INNOVATIVE BIOCERAMIX INC. |
QUANZU YANG |
K091980 |
09/22/2009 |
ACL TOP 700 LAS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
K092430 |
09/04/2009 |
1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES |
INVIRO MEDICAL DEVICES, INC. |
JIM BARLEY |
K092413 |
09/04/2009 |
INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES |
INVIRO MEDICAL DEVICES, INC. |
JIM BARLEY |
K091117 |
09/15/2009 |
ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA |
ISOAID, L.L.C. |
BENJAMIN ROEDELL |
K083559 |
09/04/2009 |
YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B |
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. |
NORMAN F ESTRIN |
K091968 |
09/14/2009 |
KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
CRYSTAL DIZOL |
K090863 |
09/21/2009 |
PERSONAL WHEEZOMETER |
KARMELSONIX |
YORAM LEVY |
K091685 |
09/03/2009 |
KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600 |
KIMBERLY-CLARK CORP. |
LISA PEACOCK |
K091562 |
09/08/2009 |
DOCTOR SMILE A-810 AND B-980 LASERS |
LAMBDA SCIENTIFIC SPA |
BOSCHI ALESSANDRO |
K091818 |
09/23/2009 |
LAURIMED SPINAL INJECTION SYSTEM |
LAURIMED LLC |
SEVRINA CIUCCI |
K091366 |
09/03/2009 |
INSUFLOW DEWHEART |
LEXION MEDICAL, LLC. |
BERNARD HORWATH |
K091981 |
09/28/2009 |
LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER |
LIGHTMED CORP. |
ANITA CHEN |
K091534 |
09/18/2009 |
LIGHTLAS MODEL 532 |
LIGHTMED CORP. |
ANITA CHEN |
K091962 |
09/30/2009 |
POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 |
LUMENIS, INC. |
MIKE AYMAMI |
K083846 |
09/01/2009 |
XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
GLORIA LEE |
K091998 |
09/28/2009 |
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP |
MAKO SURGICAL CORP. |
WILLIAM TAPIA |
K091280 |
09/25/2009 |
FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT |
MAXX ORTHOPEDICS, INC. |
MARY MCNAMARA-CULLINANE |
K092038 |
09/23/2009 |
APTUS K-WIRE SYSTEM |
MEDARTIS AG |
KEVIN THOMAS |
K092653 |
09/18/2009 |
VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 |
MEDCOM GMBH |
STEFAN WALTER |
K091953 |
09/16/2009 |
PRO-PICC |
MEDCOMP |
JEAN CALLOW |
K092347 |
09/16/2009 |
PRO-PICC CT |
MEDCOMP |
JEAN CALLOW |
K090394 |
09/01/2009 |
VALVED TEARWAY INTRODUCER |
MEDCOMP |
JEAN CALLOW |
K091991 |
09/04/2009 |
EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 |
MEDICA CORP. |
Photios Makris |
K092506 |
09/16/2009 |
EASYRA GLU-H REAGENT, MODEL 10200 |
MEDICA CORP. |
Photios Makris |
K092284 |
09/01/2009 |
LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200 |
MEDICAL DEVICE RESOURCE CORP. |
MELBOURNE KIMSEY |
K091202 |
09/16/2009 |
WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS, |
MEDSHAPE SOLUTIONS |
JACK GRIFFIS |
K091312 |
09/02/2009 |
PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM |
MEDTRONIC NEUROSURGERY |
JEFFERY HENDERSON |
K090353 |
09/29/2009 |
PERIMETER INTERBODY FUSION DEVICE |
MEDTRONIC SOFAMOR DANEK |
LEE GRANT |
K091974 |
09/02/2009 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CHRIS MCKEE |
K091883 |
09/21/2009 |
T2 SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
THERESA LEISTER |
K091798 |
09/02/2009 |
MERETE COMPRESSION SCREWS |
MERETE MEDICAL GMBH |
JORG MIETZNER |
K092553 |
09/11/2009 |
TRU FLU, MODEL 751230 |
MERIDIAN BIOSCIENCE, INC. |
SUSAN ROLIH |
K090810 |
09/18/2009 |
THERMO SCIENTIFIC CYTO-CAL COUNT TUBES |
MICROGENICS CORP. |
LISA CHARTER |
K092051 |
09/21/2009 |
THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 |
MICROGENICS CORP. |
LISA CHARTER |
K091887 |
09/18/2009 |
LED CURING LIGHT, MODEL GT-1500 |
MONITEX INDUSTRIAL CO., LTD. |
SHU-LUNG WANG |
K083840 |
09/28/2009 |
MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE |
MSI MEDSERV INTERNATIONAL DEUTSCHLAND GMBH |
CHRISTINE STROBEL |
K091218 |
09/28/2009 |
DBX DEMINERALIZED BONE MATRIX PUTTY |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY BENNEWITZ JOY |
K092003 |
09/30/2009 |
CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE |
MyCardio, LLC |
ROBERT SCHUEPPERT |
K091155 |
09/03/2009 |
ASCEND |
NEUROMETRIX, INC. |
RAINER MAAS |
K092742 |
09/22/2009 |
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YANGFANG |
K092237 |
09/09/2009 |
NSM-S15 SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YUEHUI |
K090932 |
09/24/2009 |
NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000 |
NEXGEN MEDICAL SYSTEMS, INC. |
JOHN KUCHARCZYK |
K091553 |
09/21/2009 |
BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE |
NINGBO DIAIER ELECTRONIC CO., LTD. |
LAO XIKUN |
K091756 |
09/22/2009 |
NOBELPROCERA TI ABUTMENT |
NOBEL BIOCARE AB |
HERBERT CRANE |
K091904 |
09/25/2009 |
NOBELPROCERA ZI ABUTMENT |
NOBEL BIOCARE AB |
HERBERT CRANE |
K091853 |
09/21/2009 |
WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014 |
NSPIRE HEALTH, INC. |
KIMBERLY STARK |
K091937 |
09/09/2009 |
OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM |
OBP CORPORATION |
KEITH ISAACSON |
K090174 |
09/14/2009 |
TSI; ERI |
OCO BIOMEDICAL |
JACK BLOOM |
K091495 |
09/03/2009 |
SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY ABBATIELLO |
K091759 |
09/18/2009 |
SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY ABBATIELLO KLUESNER |
K091676 |
09/01/2009 |
MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
K091411 |
09/25/2009 |
KNEEALIGN SYSTEM |
ORTHALIGN, INC |
AMY WALTERS |
K091861 |
09/03/2009 |
VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927 |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
K091614 |
09/10/2009 |
OSTEOMED FOOT PLATING SYSTEM |
OSTEOMED L.P. |
ALMA RELJA |
K091093 |
09/30/2009 |
PARCUS PPEK CF INTERFERENCE SCREW |
PARCUS MEDICAL, LLC |
BARTON BRACY |
K091094 |
09/30/2009 |
PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264 |
PARCUS MEDICAL, LLC |
BARTON BRACY |
K092332 |
09/03/2009 |
JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE) |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIAN CLEARY |
K090752 |
09/21/2009 |
PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054 |
PENUMBRA, INC. |
LOUISE MUSANTE |
K090846 |
09/03/2009 |
GSP INSTRUMENT AND GSP NEONATAL HTSH KIT |
PERKINELMER, INC. |
KAY A TAYLOR |
K091572 |
09/22/2009 |
DISPOSABLE SPO2 SENSOR M1134A |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
JENS-PETER SEHER |
K082391 |
09/01/2009 |
PRIMAEVA MEDICAL RENESIS SYSTEM |
PRIMAEVA MEDICAL, INC. |
BRIAN GRIGSBY |
K092012 |
09/25/2009 |
PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70 |
PRIMED MEDICAL PRODUCTS INC. |
RAYMOND MARUSYK |
K091964 |
09/24/2009 |
CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS |
PROCTER & GAMBLE CO. |
VICTORIA P SCHOFIELD |
K092698 |
09/15/2009 |
QUICKVUE INFLUENZA A+B TEST |
QUIDEL CORP. |
JOHN D TAMERIUS |
K091852 |
09/10/2009 |
BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205 |
REFRACTRON TECHNOLOGIES CORP. |
JOHN GAGLIARDI |
K091947 |
09/28/2009 |
S8 ASPEN WITH H4I PLUS |
RESMED LTD. |
DAVID D'CRUZ |
K091843 |
09/10/2009 |
COMFORT TWIN NASAL MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA A YURKO |
K091066 |
09/03/2009 |
COMFORT TWIN NASAL MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA A YURKO |
K092059 |
09/24/2009 |
RP CUTTING NEEDLE |
RIVERPOINT MEDICAL |
DOUG ROWLEY |
K091601 |
09/25/2009 |
ELECYS ANTI-CCP CALCHECK |
ROCHE DIAGNOSTICS CORP. |
Sarah Baumann |
K091735 |
09/25/2009 |
DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT |
S & C POLYMER GMBH |
CHRISTIAN BOETTCHER |
K092412 |
09/03/2009 |
STRONG IMPLANT HANDPIECES |
SAESHIN PRECISION CO., LTD. |
SEONG NAM KIM |
K092758 |
09/21/2009 |
X-CUBE |
SAESHIN PRECISION CO., LTD. |
Y.S. LEE |
K090742 |
09/18/2009 |
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A |
SAMSUNG MOBILE DISPLAY CO., LTD |
VINCENT LEE |
K092552 |
09/04/2009 |
CLO-SURPLUS P.A.D. |
SCION CARDIO-VASCULAR, INC. |
DENNIS HAMMOND |
K083602 |
09/03/2009 |
KAPPA LIGHT CHAINS |
SENTINEL CH. SpA |
YANGTSE PORTELLES |
K092000 |
09/18/2009 |
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES |
SHANGDONG ZIBO SHANCHUAN MEDICAL INSTRUMENTS CO. |
JOHN ZHAO |
K092683 |
09/25/2009 |
DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143 |
SHANGHAI LITTLE DOCTOR CO. LIMITED |
JANUSUN WANG |
K092719 |
09/18/2009 |
DIGITAL BLOOD PRESSURE MONITOR |
SHANGHAI LITTLE DOCTOR ELECTRONIC CO., LTD |
SELINA QIAN |
K091828 |
09/28/2009 |
SHEATHESISO ULTRASOUND TRANSDUCER COVER |
SHEATHING TECHNOLOGIES, INC. |
JENNIFER DOWNING |
K092415 |
09/25/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG ELEGANCE PLASTIC PRODUCT |
CHU XIAOAN |
K092416 |
09/16/2009 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG ELEGANCE PLASTIC PRODUCT |
CHU XIAOAN |
K092375 |
09/04/2009 |
MODIFICATION TO SI JOINT FUSION SYSTEM |
SI-BONE, INC. |
HOWARD M HOLSTEIN |
K092067 |
09/18/2009 |
ABVS WORKPLACE |
SIEMENS AG, MEDICAL SOLUTIONS |
SHELLY PEARCE |
K092145 |
09/18/2009 |
160MLC OPTION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNBAR |
K091122 |
09/18/2009 |
DIANA FUSION CAGE |
SIGNUS MEDICAL |
RICHARD JANSEN |
K090387 |
09/28/2009 |
KAINOS+ |
SIGNUS MEDIZINTECHNIK GMBH |
KAREN WARDEN |
K091014 |
09/29/2009 |
JOURNEY BCS KNEE SYSTEM |
SMITH & NEPHEW, INC. |
JASON SELLS |
K092497 |
09/11/2009 |
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1 |
SMITH & NEPHEW, INC. |
REGINA HOLMES |
K092637 |
09/24/2009 |
PACSCAN PLUS, MODELS 300P AND 300AP |
SONOMED, INC. |
CHARLES C O'NEAL |
K083597 |
09/25/2009 |
SONOWAND INVITE |
SONOWAND AS |
CONSTANCE G BUNDY |
K092396 |
09/04/2009 |
SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS |
SPECTRANETICS CORP. |
CHERYL HASTINGS |
K092128 |
09/14/2009 |
MODIFICATION TO: PSS SYSTEM |
SPINAL USA |
JEFFREY JOHNSON |
K092193 |
09/25/2009 |
SPINAL USA INTERBODY CAGES |
SPINAL USA |
JEFFREY JOHNSON |
K090315 |
09/03/2009 |
STAXX XD SYSTEM |
SPINE WAVE, INC. |
ROAIDA RIZKALLAH |
K091873 |
09/18/2009 |
TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA 12 O6-S |
SPINEART |
FRANCK PENNESI |
K091638 |
09/14/2009 |
DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031 |
SPINEFRONTIER, INC. |
JOHN SULLIVAN |
K092134 |
09/15/2009 |
STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS) |
STATRAD, LLC |
|
K091731 |
09/17/2009 |
AMSCO EVOLUTION MEDIUM STEAM STERILIZER |
STERIS Corporation |
ROBERT F SULLIVAN |
K083665 |
09/01/2009 |
VERIFY SCBI 275F 3-10 |
STERIS Corporation |
JOHN ROBERT SCOVILLE, JR. |
K091972 |
09/23/2009 |
MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01 |
STETHOSCOPE TECHNOLOGIES, INC |
DAVID STARK |
K092631 |
09/25/2009 |
MANTIS REDUX SPINAL SYSTEM |
STRYKER SPINE |
CURTIS D TRUESDALE |
K091946 |
09/25/2009 |
VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX |
STRYKER SPINE |
KIMBERLY LANE |
K092019 |
09/15/2009 |
MODEL 1014 PC ELECTROMETER |
SUN NUCLEAR CORP. |
NOEL DOWNEY |
K091919 |
09/28/2009 |
DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST |
SUNRISE MEDICAL |
BETTY L MILLER |
K092365 |
09/04/2009 |
INREACH SYSTEM, MODEL AAS00161-02 |
SUPERDIMENSION, LTD. |
JONATHAN KOVACH |
K091343 |
09/22/2009 |
MRI NEURO DRAPE |
SURGIVISION, INC. |
J. HARVEY KNAUSS |
K083817 |
09/16/2009 |
M. DIOR BRAND |
SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD. |
CHU XIAOAN |
K092646 |
09/25/2009 |
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW |
SYNTHES (USA) |
KARL J NITTINGER |
K092247 |
09/25/2009 |
SYNTHES LOCKING HAND PLATES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K091898 |
09/18/2009 |
BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234 |
TaiDoc Technology Corporation |
ERICA LI |
K082648 |
09/25/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN DAR PLASTIC & RUBBER PRODUCTS CO. LTD. |
WANG JINCHENG |
K092100 |
09/18/2009 |
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN HONGXING PLASTIC PRODUCTS CO., LTD. |
JOHN ZHAO |
K092372 |
09/11/2009 |
HEARTRAIL III GUIDING CATHETER |
TERUMO CORP. |
MARK UNTERREINER |
K090760 |
09/03/2009 |
THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 |
THERATEST LABORATORIES, INC. |
GABRIELLA LAKOS |
K090429 |
09/18/2009 |
NUNC IVF CENTERWELL AND ICSI DISHES |
THERMO FISHER SCIENTIFIC (NALGE NUNC INTL) |
ROBERT PRESCOTT |
K092248 |
09/25/2009 |
SPI CUSTOMIZABLE GINGIVA FORMER |
THOMMEN MEDICAL, AG |
LINDA K SCHULZ |
K092470 |
09/02/2009 |
OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 |
TOPCON CORP. |
TAKAO SUGAWARA |
K092621 |
09/25/2009 |
PASCAL STREAMLINE PHOTOCOAGULATOR |
TOPCON MEDICAL LASER SYSTEMS, INC |
JOHN JOSSY |
K091870 |
09/21/2009 |
TORNIER, PITON FIXATION IMPLANT SYSTEM |
TORNIER |
HOWARD L SCHRAYER |
K091697 |
09/28/2009 |
SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015 |
TRANSENTERIX, INC. |
TAMMY CARREA |
K092716 |
09/17/2009 |
ESOPHAGEAL STETHOSCOPE |
TRUER MEDICAL INC. |
TIM TRUITT |
K091415 |
09/04/2009 |
TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M |
TRULY INSTRUMENT CO., LTD. |
YANG JIAN-HAO |
K091434 |
09/04/2009 |
TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M |
TRULY INSTRUMENT CO., LTD. |
YANGJIAN HAO |
K091246 |
09/28/2009 |
ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M) |
TRUMPF MEDIZIN SYSTEME GMBH + CO. KG |
LINDSEY HENGEL |
K091588 |
09/04/2009 |
UCP HOME DRUG SCREENING TESTS |
UCP BIOSCIENCES, INC. |
NANCY CHEN |
DEN080006 |
09/11/2009 |
ULTHERA SYSTEM, MODEL 8850-0001 |
ULTHERA, INC. |
RANDALL E MILLER |
K082811 |
09/11/2009 |
URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS |
URIT MEDICAL ELECTRONIC CO., LTD. |
MARIA GRIFFIN |
K083679 |
09/11/2009 |
UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 |
UROVAL |
SHARON IVERSON |
K092612 |
09/11/2009 |
D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505 |
VASCULAR SOLUTIONS, INC. |
LISA GALLATIN |
DEN090004 |
09/11/2009 |
OVA1 TEST |
VERMILLION |
GILLIAN CRUTCHER |
K091060 |
09/23/2009 |
VESOCCLUDE LIGATING CLIP |
VESOCCLUDE MEDICAL, LLC |
DIANE N PEPER |
K092324 |
09/03/2009 |
SPIROPRO |
VIASYS HEALTHCARE GMBH |
THOMAS RUST |
K090156 |
09/01/2009 |
ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000 |
WCM WASTE & COMPLIANCE MANAGEMENT, INC. |
SARA BETH WATSON |
K092496 |
09/18/2009 |
COPRAN ZR/ORIGIN YZ |
WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG |
OLIVER PUCKERT |
K083724 |
09/02/2009 |
WIENER LAB. URINE STRIP 10 AND 11 |
WIENER LABORATORIOS S.A.I.C. |
VIVINA CETOLA |
K091942 |
09/21/2009 |
POWDER-FREE, VINYL PATIENT EXAMINATION GLOVES |
ZIBO INTCO MEDICAL PRODUCTS CO., LTD. |
JOHN ZHAO |
K091799 |
09/11/2009 |
CABLE READY CABLE GRIP SYSTEM CABLE BUTTON |
ZIMMER, INC. |
ANTHONY FRANCALANCIA |
K091508 |
09/11/2009 |
ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM |
ZIMMER, INC. |
BENJAMIN C CURSON |
K090989 |
09/23/2009 |
ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES |
ZOLL MEDICAL CORP. |
CHARLES W KOLIFRATH |