FDA 510(k) Decisions During September, 1981  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K801550 09/17/1981 3M GERMICIDAL SURGICAL INCISE DRAPE 3M COMPANY
K812442 09/16/1981 3M INFUSION SYSTEM 3M COMPANY
K812297 09/28/1981 A.D.T. PROCEDURES TRAY A.D.T. LAB INDUSTRIES
K812504 09/23/1981 ACCRA LAB WRIGHT STAIN ACCRA LABORATORIES, INC.
K812210 09/11/1981 CREAT BRAND WAGNER CHIN IMPLANT AESTHETECH CORP.
K812454 09/23/1981 PAC-AID ALBERT J. ANTHONY, DMD
K810897 09/23/1981 ALPHA PLASTIC PLASMA BOTTLE ALPHA THERAPEUTIC CORP.
K812554 09/24/1981 TOMAC STERILE DISP. LAP SPONGE AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL
K812583 09/24/1981 BOVINE CHEMISTRY CONTROL I.X. & II.X. AMERICAN DADE
K812280 09/09/1981 HEMATOLOGY CONTROL AMERICAN DADE
K812237 09/09/1981 HEMOTOLOGY QUALITY CONTROL MIXTURE AMERICAN DADE
K812541 09/23/1981 PROTEIN-BASED BLOOD GAS CONTROL AMERICAN DADE
K812563 09/25/1981 SWAN-GANZ & EDSLAB HEPARIN COATED CATH. AMERICAN EDWARDS LABORATORIES
K812051 09/08/1981 PHOTOLITE AOLITE TINTOMATIC LENS AMERICAN OPTICAL CORP.
K812300 09/21/1981 LINGUAL BRACKET AMERICAN ORMCO
K812236 09/09/1981 GOLD(AU 195) GAMMA CAMERA CHECK(FLOOD) AMERSHAM CORP.
K812235 09/09/1981 GOLD(AU 195) SPOT MARKER SOURCES AMERSHAM CORP.
K812329 09/01/1981 ZETA-SERA D AMF BIOLOGICAL AND DIAGNOSTICS CO.
K812621 09/24/1981 DELTA-A.V. FISTULA CANNULATION SET AMISCO TRADING CORP.
K812622 09/24/1981 HEMODIALYSIS VENOUS & ARTERIAL SET AMISCO TRADING CORP.
K812105 09/11/1981 ANOGO DISPOSABLE SHOE COVER ANAGO, INC.
K812276 09/25/1981 DISPOSABLE ELECTRODE, #1610 ANDOVER MEDICAL, INC.
K812314 09/01/1981 CRITHIDNA ANTI-DNA TEST KIT ANTIBODIES INC.
K812425 09/23/1981 BECKMAN R.PR CONTROL SERUM SET BECKMAN INSTRUMENTS, INC.
K812120 09/08/1981 GINGI-PLAIN CORDS & BRAIDS BELPORT CO., INC.
K812224 09/09/1981 PLEURAL DRAINAGE SYSTEM #PDS-4300 BENTLEY LABORATORIES, INC.
K812582 09/23/1981 CANCEL BIO SYSTEMS, INC.
K812108 09/24/1981 LOW FIBRINOGEN CONTROL BIO/DATA CORP.
K812163 09/21/1981 AIRE-CUF TRACHEOSTOMY TUBE BIOANA SURGICAL INSTRUMENTS, INC.
K812222 09/23/1981 EM-X BIOLOGICAL CORP. OF AMERICA
K811718 09/18/1981 SURFACE REPLACEMENT HIP PROSTHESIS BIOMET, INC.
K812447 09/09/1981 AMYLASE REAGENT KIT BIOSCIENTIFIC
K812303 09/01/1981 GLUCOSE-HK SYSTEM PACK TEST BOEHRINGER MANNHEIM CORP.
K812305 09/08/1981 MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE BOSTON MEDICAL PRODUCTS, INC.
K811848 09/08/1981 MODEL SIX BEAM SYSTEM BRAINTECH, INC.
K811925 09/08/1981 UROFLOWMETER C.R. BARD, INC.
K812307 09/21/1981 USCI TRANSTHORACIC TEMP. PACING ELECTROD C.R. BARD, INC.
K812458 09/23/1981 PADAC CALBIOCHEM-BEHRING CORP.
K812470 09/14/1981 HIPP MICROTUBE CARR MICROBIOLOGICALS
K812466 09/14/1981 ONPX-INDOL MEDIUM MICROTUBES CARR MICROBIOLOGICALS
K812467 09/14/1981 PGUA-INDOL MICROTUBE CARR MICROBIOLOGICALS
K812465 09/14/1981 PHOS MICROTUBES CARR MICROBIOLOGICALS
K812468 09/14/1981 PYRR MICROTUBE CARR MICROBIOLOGICALS
K812469 09/14/1981 RAPID DECARBOXYLASE/DIHYDROLASE MICROTUB CARR MICROBIOLOGICALS
K812212 09/01/1981 ACRIDINE ORANGE STAIN CARR-SCARBOROUGH MICROBIOLOGICALS, INC.
K812668 09/29/1981 AFB STAIN SET CARR-SCARBOROUGH MICROBIOLOGICALS, INC.
K812274 09/01/1981 AURAMINE O MYCROBACTERIAL STAIN SET CARR-SCARBOROUGH MICROBIOLOGICALS, INC.
K812277 09/08/1981 PRISMA-FIL COMPULES CAULK CO., DIV. DENTSPLY
K812006 09/08/1981 LEGIONELLA DIRECT FLUORESCENT ANTIBODY CENTERS FOR DISEASE CONTROL AND PREVENTION
K812007 09/08/1981 LEGIONELLA INDIRECT FLUOR. ANTIBODY CENTERS FOR DISEASE CONTROL AND PREVENTION
K812330 09/29/1981 DIALYSATE CONCENTRATE CENTRAL BIOLOGICAL CO.
K811831 09/08/1981 MULTI-PURPOSE DENTAL SYRINGE CENTRIX, INC.
K812238 09/11/1981 D.I.V.A.S. CGR MEDICAL CORP.
K812227 09/24/1981 GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY CLINICAL ASSAYS, INC.
K812130 09/09/1981 SPIKE GUARD CLINIPAD CORP.
K812433 09/21/1981 LENSINE EXTRA STRENGTH CLEANER COOPERVISION, INC.
K812126 09/18/1981 ULTRASONIC TIPS COOPERVISION, INC.
K811830 09/21/1981 C-DAK DUO-FLUX ARTIFICIAL KIDNEY CORDIS CORP.
K812540 09/24/1981 CORDIA IM CORDIS CORP.
K812242 09/09/1981 CORDISNHYPERION HEMOGLOBIN A1 TEST SYS CORDIS CORP.
K812311 09/16/1981 CIRCULATING CYTO-THERMS CRYOSAN, INC.
K812309 09/16/1981 CRYOSAN NORMAL SALINE CRYOSAN, INC.
K812333 09/08/1981 CYCLES REUSABLE MENSTRUAL PADS CYCLES
K812661 09/29/1981 IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA DAKO CORP.
K812662 09/29/1981 IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA DAKO CORP.
K812496 09/23/1981 IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALBUM DAKO CORP.
K812495 09/23/1981 IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHA DAKO CORP.
K812491 09/23/1981 IMMUNOGL. FRCT. OF RABBIT ANTISER.-C3 DAKO CORP.
K812490 09/23/1981 IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4 DAKO CORP.
K812486 09/23/1981 IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL DAKO CORP.
K812494 09/23/1981 IMMUNOGL. FRCT. OF RABBIT ANTISER.-HAPTO DAKO CORP.
K812488 09/23/1981 IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA DAKO CORP.
K812489 09/23/1981 IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG DAKO CORP.
K812487 09/23/1981 IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM DAKO CORP.
K812493 09/23/1981 IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO DAKO CORP.
K812492 09/23/1981 IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN DAKO CORP.
K812429 09/23/1981 DALE COMBO TRACHEOSTOMY TUBE HOLDER DALE MEDICAL PRODUCTS, INC.
K812259 09/21/1981 NIVP MONITOR DATASCOPE CORP.
K810500 09/23/1981 BLOOD FREEZING BAG DELMED, INC.
K810913 09/21/1981 CAVITY VARNISH DENTSPLY INTL.
K812012 09/24/1981 TOWNLEY UNICONDYLAR KNEE DEPUY, INC.
K812270 09/16/1981 PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL DIAG CORP.
K812434 09/23/1981 DIAGNOSTIC KITS & KIT COMPONENTS DIAGNOSTICA, INC.
K812374 09/09/1981 ADULT CHICKEN BLOOD IN ALSEVER'S, C., D. DUTCHLAND LABORATORIES, INC.
K812375 09/09/1981 BABY CHICK BLOOD IN ALSEVER'S DUTCHLAND LABORATORIES, INC.
K812383 09/08/1981 CALF (BOVINE) SERUM - STERILE DUTCHLAND LABORATORIES, INC.
K812382 09/08/1981 DONOR CALF (BOVINE-SERUM) - STERILE DUTCHLAND LABORATORIES, INC.
K812381 09/08/1981 DONOR HORSE SERUM - STERILE DUTCHLAND LABORATORIES, INC.
K812386 09/08/1981 FETAL BOVINE SERUM - STERILE DUTCHLAND LABORATORIES, INC.
K812367 09/09/1981 GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD) DUTCHLAND LABORATORIES, INC.
K812372 09/09/1981 GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF DUTCHLAND LABORATORIES, INC.
K812370 09/08/1981 GUINEA PIG COMPLEMENT REGULAR DUTCHLAND LABORATORIES, INC.
K812369 09/08/1981 GUINEA PIG COMPLEMENT VIRUS ANTIBODY DUTCHLAND LABORATORIES, INC.
K812379 09/08/1981 GUINEA PIG SERUM - STERILE DUTCHLAND LABORATORIES, INC.
K812371 09/08/1981 HEMOLYSIN DUTCHLAND LABORATORIES, INC.
K812385 09/08/1981 NATAL CALF (BOVINE) SERUM - STERILE DUTCHLAND LABORATORIES, INC.
K812384 09/08/1981 NEWBORN CALF SERUM - STERILE DUTCHLAND LABORATORIES, INC.
K812365 09/09/1981 PARA 1 SENDAI HEMAGGLUTININ DUTCHLAND LABORATORIES, INC.
K812373 09/09/1981 RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBR DUTCHLAND LABORATORIES, INC.
K812602 09/29/1981 RABBIT COAGULASE PLASMA DUTCHLAND LABORATORIES, INC.
K812522 09/23/1981 RABBIT COMPLEMENT DUTCHLAND LABORATORIES, INC.
K812380 09/08/1981 RABBIT SERUM - STERILE DUTCHLAND LABORATORIES, INC.
K812368 09/09/1981 RAT BLOOD IN ALSEVER'S, CITRATED DUTCHLAND LABORATORIES, INC.
K812376 09/09/1981 SHEEP BLOOD IN ALSEVER'S, CITR., DEFIBR DUTCHLAND LABORATORIES, INC.
K812506 09/24/1981 THE ARTHROFILE DYONICS, INC.
K812631 09/29/1981 ACA IMMUNOGLOBIN A TEST PACK E.I. DUPONT DE NEMOURS & CO., INC.
K812632 09/29/1981 ACA IMMUNOGLOBIN M TEST PACK E.I. DUPONT DE NEMOURS & CO., INC.
K812633 09/29/1981 ACA IMMUNOGLOBULIN A/M CALIBRATORS E.I. DUPONT DE NEMOURS & CO., INC.
K812630 09/29/1981 ACA IMMUNOGLOBULIN G CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC.
K812625 09/29/1981 ACA PLASMINOGEN TEST PACK E.I. DUPONT DE NEMOURS & CO., INC.
K811706 09/24/1981 LACTIC ACID DIALYSATE ADDITIVE EDLAW PHARMACEUTICALS, INC.
K812014 09/16/1981 DYNEX-44 DIAGNOSTIC ULTRASOUND IMAGING ELSCINT, INC.
K812387 09/09/1981 DIGITRON ELECTRONIC THERMOMETERS - 4700 ERCONA CORP.
K812685 09/29/1981 ERICKA NEG. PRESSURE ARTERIAL BLOOD LINE ERICKA
K811974 09/16/1981 MICROCOIL 150 DIALYZER ERIKA, INC.
K812169 09/08/1981 VISIO-FIL ESPE GMBH (US)
K812291 09/11/1981 ETHICON MULTIPLE LIGATING CLIP APPLIER ETHICON, INC.
K811935 09/11/1981 PROLENE POLYPROPYLENE LIGATING CLIP ETHICON, INC.
K812648 09/29/1981 EHTOX GASTRIC LAVAGE KIT #2050 & #2070 ETHOX CORP.
K812459 09/25/1981 EXMOOR AURAL GROMMET AG/TI EXMOOR PLASTICS LTD.
K812460 09/21/1981 VARIOUS AURAL GROMMETS EXMOOR PLASTICS LTD.
K810902 09/11/1981 IP-758 BURN WOUND DRESSING EXOPACK
K812544 09/21/1981 RELIANCE OPHTHALMIC INSTRUMENT CONTROL F. & F. KOENIGKRAMER
K810876 09/21/1981 SPECTACLE FRAMES FASHIONLINE CORP.
K812175 09/21/1981 ENDOCERVICAL ASPIRATOR FERTILITY INSTRUMENTATION, INC.
K812553 09/23/1981 AQUEOUS BLOOD GAS CONTROLS FISHER SCIENTIFIC CO., LLC.
K812335 09/09/1981 TRYPTICASE SOY BROTH BLOOD CULTURE BOTT FISHER SCIENTIFIC CO., LLC.
K812340 09/23/1981 TITERTEK MICROPLATE INCUBATOR FLOW LABORATORIES, INC.
K812346 09/11/1981 ALUMINUM SCOOP DISK FRED SAMMONS, INC.
K812345 09/11/1981 ARM SLINGS FRED SAMMONS, INC.
K812348 09/11/1981 DESK ARM WHEELCHAIR ARM EXTENSION FRED SAMMONS, INC.
K812349 09/11/1981 HAND SPLINTS & COMPONENTS FRED SAMMONS, INC.
K812344 09/11/1981 HEEL OR ELBOW PROTECTOR FRED SAMMONS, INC.
K812352 09/14/1981 HYGIENE ADAPTORS FRED SAMMONS, INC.
K812351 09/14/1981 NON-MEASURING EXERCISERS FRED SAMMONS, INC.
K812343 09/11/1981 PINCH METER FRED SAMMONS, INC.
K812347 09/11/1981 RAISED CHAIR W/FOOT PLATFORM FRED SAMMONS, INC.
K812350 09/11/1981 WHEELCHAIR ACCESSORIES FRED SAMMONS, INC.
K812568 09/25/1981 "CAVITRON" G-C INTL. CORP.
K812600 09/23/1981 GER 540, GER 541 MANUAL BED G.W. HEALTHCARE, INC.
K812131 09/21/1981 PORTAPULSE GAVON, INC.
K812253 09/01/1981 GELMAN IG-FIX KIT GELMAN SCIENCES, INC.
K812241 09/09/1981 CT/T 9800 GENERAL ELECTRIC CO.
K812451 09/23/1981 CAMPY THIOGLYCOLLATE (TUBE) GRANITE DIAGNOSTICS, INC.
K812595 09/29/1981 ULTRA CHEM E-GLU #64976 & 65040 HARLECO
K812589 09/24/1981 ULTRA CHEM E-TRIG #65024 HARLECO
K812596 09/29/1981 ULTRA ZYME PLUS ALP #64962, 65029 & 30 HARLECO
K812592 09/24/1981 ULTRA ZYME PLUS GOT #64953, 65033 & 34 HARLECO
K812591 09/24/1981 ULTRA ZYME PLUS GPT, #64956, 65035 & 36 HARLECO
K812590 09/24/1981 ULTRA ZYME PLUS LDH #64950, 65038 & 39 HARLECO
K812500 09/23/1981 ULTRACHEM URIC ACID ALDH, ITEM #65047 HARLECO
K812507 09/14/1981 THE KEOFEED STOMACH TUBE HEDECO
K812226 09/01/1981 HELENA HBF QUIPLATE CONTROL HELENA LABORATORIES
K812533 09/29/1981 PLATELET AGITATOR HELMER LABS, INC.
K812317 09/21/1981 DEFIBRILLATOR/MONITOR HEWLETT-PACKARD CO.
K812068 09/08/1981 PROPOSED CONTROLS FOR DOSIMETRIC RELEASE HEXCEL MEDICAL
K811959 09/01/1981 TANDEM PAP KIT - (PARTS I & II) HYBRITECH, INC.
K812497 09/23/1981 IMMULIK STAIN PLATE IMMULOK, INC.
K812427 09/23/1981 CARTMILL/BARRY FEEDING TUBE IMPRA, INC.
K812289 09/01/1981 CELESTIN DILATOR INMED CORP.
K801337 09/23/1981 CYBERLITH IX IMPLANTABLE PULSE GENERATOR INTERMEDICS, INC.
K811464 09/23/1981 MODEL 535-01 TRACE-A-PACE EKG/TELEMETRY INTERMEDICS, INC.
K801339 09/23/1981 TELEMETRY DECODER INTERMEDICS, INC.
K812355 09/09/1981 IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2 INTL. BUSINESS MACHINES
K812318 09/01/1981 LIPO-SEP CHOLESTEROL AUDIT SYSTEM ISOLAB, INC.
K812449 09/25/1981 ADAPTIC* C.F.S. JOHNSON & JOHNSON PROFESSIONALS, INC.
K812414 09/14/1981 KALLESTAD 125I ANTISERUM TO HUMAN IGE KALLESTAD LABORATORIES, INC.
K812415 09/09/1981 KALLESTAD ANTISERA TO TOBRAMYCIN KALLESTAD LABORATORIES, INC.
K812327 09/01/1981 KAPPA & LAMBDA BENCE JONES CONTROLS KALLESTAD LABORATORIES, INC.
K812399 09/14/1981 CHAIR, ADJUSTABLE, MECHANICAL KAYE PRODUCTS, INC.
K812332 09/16/1981 KERMATH L/C ARM KERMATH MFG. CORP.
K812217 09/16/1981 FLUORO AUTOMATIC BRIGHTNESS SYS KEYSTONE X-RAY, INC.
K812450 09/21/1981 KOI DIAMOND KNIFE KOI, INC.
K812354 09/25/1981 KONTRON PMS 7000 KONTRON INSTRUMENTS, INC.
K812519 09/25/1981 2000 SERIES PORTABLE RESUSCITATION SYST. LIFE SCIENCE INSTRUMENTATION, INC.
K812520 09/25/1981 280/4 MINI-DEFIBRILLATOR LIFE SCIENCE INSTRUMENTATION, INC.
K812145 09/25/1981 CARDIORATER CR-3 LIFE SCIENCE INSTRUMENTATION, INC.
K812146 09/25/1981 CARDIORATER CR-5 LIFE SCIENCE INSTRUMENTATION, INC.
K812147 09/25/1981 CARDIORATER CR-7 LIFE SCIENCE INSTRUMENTATION, INC.
K812144 09/25/1981 CENTERAL MONITOR 360 LIFE SCIENCE INSTRUMENTATION, INC.
K812177 09/09/1981 LIFE-TECH #1857 PRESSURE/POLOT MODULE LIFE-TECH INSTRUMENTS, INC.
K812158 09/16/1981 LKB-BROMMA 2188 ULTROTOME NOVA LKB INSTRUMENTS, INC.
K812123 09/23/1981 CYTOMEGELISA TEST KIT M.A. BIOPRODUCTS
K810958 09/16/1981 GLYCOHEMOGLOBIN MACOMB CHEMICAL CO.
K812477 09/14/1981 ARM SLING, POUCH TYPE MADDAK, INC.
K812474 09/14/1981 BABY WALKER W/TOY CHEST MADDAK, INC.
K812481 09/14/1981 BACKREST MADDAK, INC.
K812482 09/24/1981 FOAM WEDGE MADDAK, INC.
K812480 09/14/1981 LIMB HOLDER ARM SLING MADDAK, INC.
K812478 09/14/1981 MADDACOMFORT SLING MADDAK, INC.
K812483 09/14/1981 SECURA BATH SEAT MADDAK, INC.
K812475 09/14/1981 TRANSFER BENCH MADDAK, INC.
K812654 09/25/1981 VELCRO FINGER/TOE SPLINT MADDAK, INC.
K812655 09/25/1981 VELCRO SPLINT STRAP FASTENERS MADDAK, INC.
K812249 09/23/1981 SKIN ADHESIVE-50XX MANFRED SAUER CORP.
K811441 09/16/1981 MANUFACTURING PROCESS CHANGE MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
K812152 09/09/1981 MEDI VIEW MEDICAL SYNERGY
K812353 09/16/1981 KF-E SERIES OF HOLLOW FIBER DIALYZERS MEDISYSTEMS CORP.
K811839 09/08/1981 MEDISYSTEM NEGATIVE PRESSURE MEDISYSTEMS CORP.
K811838 09/08/1981 MEDISYSTEMS FISTULA NEEDLE MEDISYSTEMS CORP.
K812045 09/24/1981 INFANT APNEA MONITOR MODEL 100 MEDIX MEDICAL ELECTRONICS (U.S.A.), INC.
K812040 09/21/1981 OXYGEN MONITOR 140/141 MEDIX MEDICAL ELECTRONICS (U.S.A.), INC.
K812039 09/25/1981 SPIROMETER 210/211 MEDIX MEDICAL ELECTRONICS (U.S.A.), INC.
K812041 09/25/1981 VENTI-MONITOR MODEL 101 MEDIX MEDICAL ELECTRONICS (U.S.A.), INC.
K811783 09/11/1981 ENDOPUMP MEDTRON DEVELOPMENT LTD.
K812418 09/16/1981 MEDTRONIC #3798 ELECTRODE MEDTRONIC VASCULAR
K812096 09/16/1981 MEDTRONIC ENERTRAX MODEL 7100 MEDTRONIC VASCULAR
K812580 09/23/1981 MEDTRONIC MODEL 2409 MEDTRONIC VASCULAR
K812162 09/24/1981 HEMODIALYSIS TRANSDUCER PROTECTOR MEMBRANA
K812394 09/08/1981 MRI GENTAMICIN RIA KIT MICROANALYTIC RESEARCH, INC.
K812518 09/23/1981 AMES TDA THEOPHYLLINE TEST MILES LABORATORIES, INC.
K811342 09/01/1981 REAGENT STRIPS FOR URINALYSIS MILES LABORATORIES, INC.
K812558 09/29/1981 TISSUE-TEK III ACCU-CUT ROTARY MICROTOME MILES LABORATORIES, INC.
K812513 09/21/1981 MINI O2 MOUNTAIN MEDICAL EQUIPMENT, INC.
K811821 09/24/1981 CAROTID ARTERY CLAMP & TOOLS NEW ENGLAND SURGICAL INSTRUMENT CORP.
K811893 09/08/1981 NOVAMETRIX PHYSIOLOGICAL MONITOR #910 NOVAMETRIX MEDICAL SYSTEMS, INC.
K812404 09/09/1981 BUTTERFLY NEEDLE ASSEMBLY NU TECH MEDICAL SYSTEMS
K812499 09/16/1981 INFUSION PUMP NU TECH MEDICAL SYSTEMS
K812334 09/01/1981 B-NEOCEPT ORGANON, INC.
K811567 09/16/1981 ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S ORTHO DIAGNOSTIC SYSTEMS, INC.
K812215 09/01/1981 ANTITHROMBIN III SCREEN KIT PACIFIC HEMOSTASIS
K812658 09/29/1981 CEA CONTROL PLASMA PACIFIC HEMOSTASIS
K812505 09/16/1981 PALL ULTIPOR VACUUM LINE BACTERIA FITLER PALL BIOMEDICAL PRODUCTS CO.
K811995 09/21/1981 FORAMATRON APICAL FORAMEN LOCATOR PARKER LABORATORIES, INC.
K811629 09/08/1981 DYNA- MO PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K812534 09/21/1981 IMPROVED PLAYTEX TAMPON PLAYTEX, INC.
K812452 09/09/1981 ALKALINE PHOSPHATASE POINTE SCIENTIFIC, INC.
K812574 09/24/1981 HDL CHOLESTEROL REAGENT POINTE SCIENTIFIC, INC.
K812341 09/01/1981 UREA NITROGEN (BUN) POINTE SCIENTIFIC, INC.
K812430 09/09/1981 URIC ACID REAGENT SET POINTE SCIENTIFIC, INC.
K812403 09/09/1981 SCENTED MENSTRUAL PADS PROCTER & GAMBLE MFG. CO.
K812402 09/09/1981 UNSCENTED MENSTRUAL PADS PROCTER & GAMBLE MFG. CO.
K812125 09/24/1981 LAPIN CLEAR CUT II PROMED CORP.
K811761 09/21/1981 THE EMMETT IUD THREAD RETRIEVER PROTO-MED, INC.
K811425 09/16/1981 CARDIACMONITORS PULSE TIME PRODUCTS, LTD.
K812417 09/09/1981 BLOOD UREA NITROGEN(BUN-UV) REAGENTS APPLICATIONS, INC.
K812503 09/24/1981 BOSCH HEARING INSTRUMENTS RETLIF, INC.
K812198 09/11/1981 ACCESSORIES(PROBES, SUCTION TUBES, ETC.) REZNIK INSTRUMENTS
K812202 09/29/1981 FIBER OPTIC LIGHT SOURCE REZNIK INSTRUMENTS
K812200 09/29/1981 INSUFFLATOR REZNIK INSTRUMENTS
K811632 09/11/1981 UNSTERILIZED LAPAROTOMY SPONGES (CHINA) ROBERT I. CHIEN & ASSOC., INC.
K812299 09/11/1981 ELECTRO-SNAP RODEL PRODUCTS CORP.
K811863 09/21/1981 STERI-TRACT ROGO ENT.
K812313 09/01/1981 SANDARE URIC ACID PROCEDURE SANDARE CHEMICAL CO., INC.
K812547 09/23/1981 "BEAUBON" SCI-PHARM, INC.
K812550 09/25/1981 "BEAUCAV" SCI-PHARM, INC.
K812551 09/23/1981 "BEAUCOR" SCI-PHARM, INC.
K812546 09/25/1981 "BEAUDENT" SCI-PHARM, INC.
K812545 09/25/1981 "BEAUFILL" SCI-PHARM, INC.
K812549 09/25/1981 "BEAUSEAL" SCI-PHARM, INC.
K812548 09/25/1981 "COBEAU" SCI-PHARM, INC.
K812453 09/23/1981 SCRIPPSYSTEM IMMUNOGLOBIN RID KIT SCRIPPS-MILES, INC.
K812328 09/08/1981 SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT SCRIPPS-MILES, INC.
K812569 09/25/1981 SHERWOOD WATER TRAP SHERWOOD MEDICAL CO.
K812302 09/08/1981 SHILEY FENESTRATED LOW PRESS. CUFFED SHILEY, INC.
K812431 09/23/1981 FACTOR VIII DEFICIENT PLASMA #B8D SIGMA CHEMICAL CO.
K812472 09/14/1981 SPIN-CHEM LD-L REAGENT SMITH KLINE DIAGNOSTICS, INC.
K812471 09/14/1981 SPIN-CHEM TRIGLYCERIDES REAGENT SMITH KLINE DIAGNOSTICS, INC.
K812324 09/25/1981 FLOW-DIRECTED THERMODILUTION CATHETER SORENSEN RESEARCH
K812325 09/21/1981 INTK-08 8 FRENCH INTRODUCER KIT W/SIDE SORENSEN RESEARCH
K812326 09/25/1981 SORENSON SUBCLAVIAN CATHETER SSC-8 SORENSEN RESEARCH
K812234 09/11/1981 STORZ/OLYMPUS MICROSCOPE SYSTEM STORZ INSTRUMENT CO.
K811741 09/24/1981 CELL-CHEX RBC STRECK LABORATORIES, INC.
K812401 09/14/1981 CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O SURGICAL APPLIANCE INDUSTRIES, INC.
K812422 09/14/1981 CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS SURGICAL APPLIANCE INDUSTRIES, INC.
K812423 09/14/1981 NEOPRENE KNEE SUPPORT SURGICAL APPLIANCE INDUSTRIES, INC.
K812272 09/08/1981 CASTLE TEC-TEST BIOLOGICAL INDICATOR SYBRON CORP.
K811270 09/08/1981 "SCOPE MASTER" SYNEMED, INC.
K811523 09/09/1981 PLASMA FLEX TERUMO AMERICA, INC.
K812498 09/29/1981 CLIRANS TE12 HOLLOW FIBER DIALYZER TERUMO MEDICAL CORP.
K812338 09/23/1981 PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY TERUMO MEDICAL CORP.
K812339 09/09/1981 TERUFUSION INFUSION PUMP MODEL STC-502 TERUMO MEDICAL CORP.
K811942 09/08/1981 J & S IRON SATURATING REAGENT THYROID DIAGNOSTICS, INC.
K812419 09/21/1981 PRESET FLOWMETER TIMETER INSTRUMENT CORP.
K812552 09/23/1981 COROMETRICS MEDICAL SYST. 220 PH ANALY. TRANSIDYNE GENERAL CORP.
K811753 09/11/1981 SURGEON'S GLOVES TRAVENOL LABORATORIES, S.A.
K812510 09/16/1981 TRAVENOL INFUSION CONTROLLER 2M8052 TRAVENOL LABORATORIES, S.A.
K812457 09/21/1981 HIFLO-HP TRI-MED, INC.
K812527 09/16/1981 IVA SEAL II U.S. CLINICAL PRODUCTS, INC.
K812184 09/09/1981 ANGIOSCAN SPECTRUM ANALYZER UNIGON INDUSTRIES, INC.
K812536 09/23/1981 LINDE MARK II UNION CARBIDE CORP.
K812239 09/21/1981 UNITEK PALATAL BAR UNITEK CORP.
K812581 09/23/1981 SENSI-TECT UTI-TECT, INC.
K812357 09/01/1981 VENTREX DATA REDUCTION & QUAL. CONTR. SY VENTREX LABORATORIES, INC.
K812526 09/16/1981 MICRO BLADE II VXTRA CORP.
K811841 09/16/1981 GORE-TEX CARDIOVASCULAR PATCH W.L. GORE & ASSOCIATES,INC
K812284 09/08/1981 ZEE ELECTRODE-GEL ZEE MEDICAL PRODUCTS CO., INC.
K812342 09/21/1981 ZEE EXTRICATION DEVICE ZEE MEDICAL PRODUCTS CO., INC.
K811671 09/16/1981 CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM ZEUS SCIENTIFIC, INC.
K812085 09/01/1981 HERPES VIRUS HOMINIS ANTIBODY TEST SYS. ZEUS SCIENTIFIC, INC.
K812360 09/21/1981 PRECIOUS-METAL/PLASTIC ATTACH., AUXILL ZL-MICRODENT-ATTACHMENTS


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