FDA 510(k) Decisions During December, 1980  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K801748 12/18/1980 3M I-125 SEEDS IN ABSORBABLE CARRIER 3M COMPANY
K803105 12/31/1980 SARNS INFANT ARTERIAL BUBBLE SENSOR 3M HEALTH CARE, SARNS
K802902 12/19/1980 CYBREX CARBAMAZEPINE ABBOTT LABORATORIES
K803075 12/22/1980 DIGOXIN RIABEAD DIAGNOSTIC KIT ABBOTT LABORATORIES
K802309 12/01/1980 MS-2 IDENTIFICATION SYSTEM ABBOTT LABORATORIES
K802861 12/11/1980 COMBINATION PADS STERILE SINGLES ABCO DEALERS, INC.
K803151 12/30/1980 ECG & ULTRASOUND GELS, CREAMS & LOTION ABCO DEALERS, INC.
K802992 12/30/1980 ELASTIC GAUZE ABCO DEALERS, INC.
K802862 12/11/1980 GAUZE PADS STERILE SINGLES ABCO DEALERS, INC.
K802863 12/11/1980 GAUZE SPONGES ABCO DEALERS, INC.
K802860 12/11/1980 POST OP. SPONGES STERILE ABCO DEALERS, INC.
K802991 12/30/1980 ROLL STRETCH GAUZE ABCO DEALERS, INC.
K802382 12/16/1980 SONIC EAR ACOUSTICON ELECTRONICS
K802998 12/22/1980 PATIENT CARE DISPOSABLE INFANT SHIRTS AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL
K803045 12/22/1980 IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. AMERICAN DADE
K802841 12/18/1980 DIGOXIN RADIOIMMUNOASSAY KIT AMERICAN DIAGNOSTIC CORP.
K802586 12/18/1980 AMERICAN HEYER-SCHULTE LOW PROFILE VALVE AMERICAN HEYER SCHULTE
K803080 12/22/1980 ALL PUPOSE URETHRAL CATHETER AMERICAN HOSPITAL SUPPLY CORP.
K803079 12/22/1980 FOLEY CATHETER AMERICAN HOSPITAL SUPPLY CORP.
K803117 12/23/1980 CUSTOM DRESSING TRAY WET TO DRY AMERICAN MEDICAL DISPOSABLE, INC.
K803114 12/22/1980 HYPERALIMENTATION DRESSING CHANGE TRAY AMERICAN MEDICAL DISPOSABLE, INC.
K803119 12/30/1980 LARGE WOUND DRESSING KIT AMERICAN MEDICAL DISPOSABLE, INC.
K803118 12/22/1980 SIMPLE DRESSING TRAY #82028 AMERICAN MEDICAL DISPOSABLE, INC.
K800746 12/16/1980 UNIFOCAL VP, MODELS 7501 AND 7502 AMERICAN PACEMAKER CORP.
K803097 12/22/1980 DIGOXIN & PHENYTOIN CONTROL SERA AMERSHAM CORP.
K802963 12/19/1980 101, 151, 161 PORTABLE AUDIOMETERS AMPLAID USA, INC.
K802838 12/11/1980 STERNUM SAW BLADE AMSCO CO.
K802980 12/19/1980 DISPOSABLE STERILE LAP SPONGE ANAGO, INC.
K802641 12/11/1980 GAMMEX SURGICAL GLOVES ANSELL, INC.
K802877 12/19/1980 AMIKACIN RIA KIT ANTIBODIES INC.
K802999 12/22/1980 BETA-TEC QUALITATIVE ARMKEL, LLC.
K802774 12/16/1980 FIBER OPTIC ADAPTER #60-0892 ASPEN LABORATORIES, INC.
K802772 12/16/1980 FIBER OPTIC ADAPTER #60-0894 ASPEN LABORATORIES, INC.
K802775 12/16/1980 FIBER OPTIC ADAPTER #60-0896 ASPEN LABORATORIES, INC.
K802768 12/16/1980 FIBER OPTIC ADAPTER #60-0897 ASPEN LABORATORIES, INC.
K802771 12/16/1980 FIBER OPTIC ADAPTER #60-895 ASPEN LABORATORIES, INC.
K802766 12/16/1980 FIBER OPTIC ADAPTER CAT#60-0898 ASPEN LABORATORIES, INC.
K802769 12/11/1980 FIBER OPTIC HEADLIGHT #60-0765 ASPEN LABORATORIES, INC.
K802770 12/11/1980 FIBER OPTIC HEADLIGHT #60-0766766 ASPEN LABORATORIES, INC.
K802773 12/16/1980 FIBER OPTIC LIGHT GUIDE #60-0767 ASPEN LABORATORIES, INC.
K802767 12/16/1980 FIBER OPTIC LIGHT GUIDE CAT#60-0768 ASPEN LABORATORIES, INC.
K802954 12/17/1980 DRESSING CHANGE TRAY-MEDIUM ASSOCIATED MEDICAL PRODUCTS CO.
K802644 12/22/1980 EMERG. OXYGEN KIT #65350 & #65399 CASE B & F MEDICAL PRODUCTS, INC.
K802869 12/11/1980 BACKTRAC 90-90 TRACTION BACKTRAC
K803027 12/22/1980 CDC ANAEROBE BL AGAR W/PHENYLETHYL ETC. BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K803022 12/22/1980 CDC ANAEROBE BLD AGAR W/KANAMYCIN ETC. BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K803025 12/22/1980 CDC ANAEROBE BLOOD AGAR BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K803024 12/22/1980 CDC ANAEROBE LAKED BL AGAR W/PARAMOMY. BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K803023 12/22/1980 ENRICHED THIOGLYCOLLATE MEDIUM BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K803026 12/22/1980 PEPTONE YEAST EXTRACT GLUCOSE BROTH BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K802688 12/18/1980 RHEUMATOID FACTOR TEST SYSTEMS BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K802923 12/19/1980 BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY BECKMAN INSTRUMENTS, INC.
K802854 12/11/1980 BECKMAN ICS DRUG CONTROL SERA BECKMAN INSTRUMENTS, INC.
K802339 12/18/1980 EIA RUBELLA-G BECKMAN INSTRUMENTS, INC.
K802810 12/10/1980 HEXOKINASE, GLUCOSE BECKMAN INSTRUMENTS, INC.
K802628 12/11/1980 PARAGON ELECTROPHORESIS LACTATE REAG.KIT BECKMAN INSTRUMENTS, INC.
K802821 12/11/1980 PARAGON HEMOGLOBIN ELECTRO. REAG. KIT BECKMAN INSTRUMENTS, INC.
K802822 12/11/1980 PARAGON LIPOPROTEIN ELECTRO. REAG. KIT BECKMAN INSTRUMENTS, INC.
K801633 12/18/1980 THE BRAVO NEW PARALLEL FLOW DIALYZER BELLCO ARTIFIDIAL ORGAN SPEC., INC.
K801634 12/17/1980 THE VITA 2 DISPOSABLE DIALYZER BELLCO ARTIFIDIAL ORGAN SPEC., INC.
K802848 12/11/1980 CARDIOPLEGIA COOLING SYST. CCAS-2 BENTLEY LABORATORIES, INC.
K802847 12/16/1980 OXYGEN SATURATION METER MODEL NO. SM-1 BENTLEY LABORATORIES, INC.
K802719 12/16/1980 SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S BENTLEY LABORATORIES, INC.
K802720 12/16/1980 SPIRAFLO BLOOD OXYGENATORS MODEL BOS-5S BENTLEY LABORATORIES, INC.
K802740 12/10/1980 FLUFF UNDERPAD TYPE UP1001 BIO D CORP.
K802730 12/10/1980 FLUFF UNDERPAD TYPE UP1002 BIO D CORP.
K802738 12/18/1980 URINE COLLECTION BAG TYPE 1505V BIO D CORP.
K802737 12/18/1980 URINE COLLECTION BAG TYPE 1590V BIO D CORP.
K802729 12/18/1980 URINE COLLECTION BAG TYPE 2132V BIO D CORP.
K802734 12/18/1980 URINE COLLECTION BAG TYPE 710 BIO D CORP.
K802739 12/18/1980 URINE COLLECTION BAG TYPE 710AP BIO D CORP.
K802735 12/18/1980 URINE COLLECTION BAG TYPE 740AP BIO D CORP.
K802733 12/18/1980 URINE COLLECTION BAG TYPE AP2090V BIO D CORP.
K802732 12/18/1980 URINE COLLECTION BAG TYPE AP2132V BIO D CORP.
K802736 12/18/1980 URINE COOLECTION BAG TYPE 2090V BIO D CORP.
K802092 12/18/1980 HF-100 DIALYZER BIO-MED CORP.
K802944 12/22/1980 QUANTIMUNE E3 RIA BIO-RAD
K803030 12/22/1980 THE BIO-TEK CHROMOSCAN BIO-TEK INSTRUMENTS, INC.
K802356 12/01/1980 VON WILLEBRAND FACTOR ASSAY BIO/DATA CORP.
K802752 12/10/1980 POROUS, BREATHING TAPE W/RELEASE LINER BIOADHESIVE SYSTEMS, INC.
K803014 12/22/1980 SENSOMAT BIOCHEM INTERNATIONAL, INC.
K802842 12/18/1980 SINGLE VIAL LIPASE TEST KIT BIODYNAMICS CORP.
K802308 12/01/1980 T/K (ATA/AMA) UNIVERSAL BIOPAK BIOWARE PRODUCTS
K802304 12/01/1980 SOLAR TONE BLOOMEX INTERNATIONAL, INC.
K802916 12/19/1980 MONTG. TRACHEAL CANNULA BOSTON MEDICAL PRODUCTS, INC.
K802915 12/19/1980 MONTG. TRACHEAL TREPHINE FENE STRATOR BOSTON MEDICAL PRODUCTS, INC.
K802662 12/16/1980 POLYCARBONATE TEMPORARY CEMENT BUFFALO DENTAL MFG. CO., INC.
K802906 12/16/1980 WILLIAM HARVEY OXYGENATING GAS FILTER C.R. BARD, INC.
K802102 12/18/1980 RUBELLA ELISA REAGENTS RUBELLA IGG ANTI CALBIOCHEM-BEHRING CORP.
K802352 12/22/1980 MICRO THIN-DII, #0521 CARDIAC PACEMAKERS, INC.
K802353 12/22/1980 MICRO THIN-PII, #0523 CARDIAC PACEMAKERS, INC.
K803035 12/22/1980 MICROTHIN-PII BIPOLAR PULSE GEN. #0621 CARDIAC PACEMAKERS, INC.
K803034 12/22/1980 MICROTHIN-PII BIPOLAR PULSE GEN. #0623 CARDIAC PACEMAKERS, INC.
K802230 12/22/1980 BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP CARDIO MED SUPPLIES, INC.
K803041 12/30/1980 SERUM FREE TISSUE CULTURE MEDIA CARTAYA ASSOC.
K802928 12/17/1980 SPIROMETRIC COMPUTER #SC-10 CAVITRON CORP.
K802704 12/11/1980 SIAM 80-INSTANTANEOUS SONOGRAPH W/STOR. CGR MEDICAL CORP.
K802651 12/17/1980 POSTOPERATIVE UV GLASSES (PLANO/APHAKIC) CHIRON VISION CORP.
K802814 12/10/1980 ORTHOFIX AXIALEXTERNAL FIXATION SYS. CINTOR ORTHOPAEDIC DIV.
K802627 12/16/1980 ORTRON 90* HIP PROSTHESIS CINTOR ORTHOPAEDIC DIV.
K802432 12/01/1980 GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT. CLINTECH DIAGNOSTICS CORP.
K802895 12/22/1980 COBE CENTRY 2 VARIABLE CONCENTRATE-18- COBE LABORATORIES, INC.
K802250 12/10/1980 DIALYSIS CONTROL UNIT-CENTRY 2000 COBE LABORATORIES, INC.
K802845 12/17/1980 CONCEPT CANALICULUS INTUBATION SET CONCEPT, INC.
K803174 12/30/1980 CONPHAR PERCUSSION HAMMER(BUCK TYPE) CONPHAR, INC.
K802884 12/22/1980 CORNING NORMAL GLYCOSYLATED HEMOGLOBIN CORNING MEDICAL & SCIENTIFIC
K803060 12/22/1980 FOLATE 125I RADIOIMMUNOASSAY CORNING MEDICAL & SCIENTIFIC
K802661 12/10/1980 LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT DAMON CORP.
K802859 12/31/1980 BEHIND-THE-EAR HEARING AID DANAVOX, INC.
K803102 12/22/1980 ARTERIAL BUBBLE TRAP K-20 DELTA MEDICAL INDUSTRIES
K803101 12/22/1980 PREBYPASS FILTER CAT.#K-5 DELTA MEDICAL INDUSTRIES
K803072 12/30/1980 HIGH FREQUENCY AUDIOMETER DELMAR #20-K DEMLAR MEDICAL, INC.
K802853 12/18/1980 CLEANSER, ROOT CANAL DENTSPLY INTL.
K802835 12/11/1980 COMPU-CHEM II CHEMISTRY ANALYZER DIAGNOSTIC AIDS, INC.
K801175 12/18/1980 SILASTIC II MAMMARY IMPLANT DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K802837 12/10/1980 DR. MICHAEL'S FOOT HELPER DR. MICHAEL'S FOOT-CARE PRODUCTS
K802168 12/20/1980 DRAGER AV2 ANESTHESIA VENTILATOR DRAEGER MEDICAL, INC.
K803177 12/31/1980 MOIST HEAT PACK DURO-MED IND., INC.
K802857 12/11/1980 IMMULON REMOVAWELL STRIPS #011-010-6301 DYNATECH CORP.
K802883 12/19/1980 T3-SQUIBB RIA KIT E. R. SQUIBB & SONS, INC.
K803002 12/22/1980 ELECATH FLUID-DRAIN ASSEMBLY ELECTRO-CATHETER CORP.
K802507 12/01/1980 TENSMATE EMPIMODEL 9980 EMPI
K802881 12/19/1980 ABSELE* ABSORBABLE BONE SEALANT ETHICON, INC.
K803038 12/30/1980 PROXIMATE*II DISPOSABLE SKIN STAPLER ETHICON, INC.
K802880 12/17/1980 EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K803059 12/22/1980 INTERSEPT* VENOUS RESERVOIR BAG & HOLDER EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K802381 12/17/1980 LEWICKY ANTERIOR CHAMBER MAINTEN. SYS. FIBRA SONICS, INC.
K802956 12/22/1980 GAMBRO A-V FISTULA NEEDLE SET GAMBRO, INC.
K802389 12/22/1980 GAMBRO LUNDIA PLATE DISP. DIALYZER GAMBRO, INC.
K802831 12/18/1980 GAMBRO PERITONEAL DIALYSIS MONITOR GAMBRO, INC.
K803039 12/22/1980 PROFILE ANTI-CONVUL. SET ASSAYED S. CTL. GENERAL DIAGNOSTICS
K803036 12/22/1980 PROFILE CARDIAC SET ASSAYED SERUM CONTR. GENERAL DIAGNOSTICS
K802548 12/02/1980 GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80 GENERAL ELECTRIC CO.
K802549 12/02/1980 GENERATOR, HIGH VOLT, X-RAY, MPX 100 GENERAL ELECTRIC CO.
K802550 12/02/1980 GENERATOR, HIGH VOLT, X-RAY, MPX 125 GENERAL ELECTRIC CO.
K802551 12/02/1980 GENERATOR, HIGH VOLT, X-RAY, MPX100/125 GENERAL ELECTRIC CO.
K802332 12/22/1980 INTRAJECT GENERAL MEDICAL ENGINEERING CORP.
K802678 12/10/1980 TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR GENERAL MEDICAL INDUSTRIES, INC.
K803121 12/30/1980 MENTOR 150 TRANSCUTANEOUS NERVE STIMULA GEORGE H. FRISCH
K803113 12/30/1980 MENTOR 402 TRANSCUTANEOUS ELEC. STIMULAT GEORGE H. FRISCH
K802957 12/22/1980 MUELLER HINTON BROTH GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K802632 12/11/1980 ALBUMIN/TOTAL PROTEIN STANDARDS GILFORD DIAGNOSTICS
K802633 12/11/1980 BUN/GLUCOSE STANDARDS GILFORD DIAGNOSTICS
K802631 12/11/1980 CREATININE STANDARDS GILFORD DIAGNOSTICS
K802750 12/31/1980 NUVOX BEDSIDE TINNITUS MASKER HAL-HEN CO., INC.
K802583 12/18/1980 INFANT VENTILATOR, (RESPIRATOR) PLAN B HEALTHDYNE, INC.
K802912 12/22/1980 HELENA AT-III QUIPLATE PROCEDURE HELENA LABORATORIES
K803016 12/30/1980 HELENA HEMESPEC II TOTAL HEMOGLOBIN MET. HELENA LABORATORIES
K803015 12/30/1980 HEMESPEC II HELENA LABORATORIES
K802608 12/11/1980 HEMATIC "BLOOD MIXER" HELMER LABS, INC.
K801954 12/16/1980 HP MODEL 77020A ULTRASOUND SYSTEM HEWLETT-PACKARD CO.
K802513 12/16/1980 DPA 207 PERSONAL HILL, FARRER & BORRILL TIM C BRUINSMA
K802951 12/17/1980 I.M PROBES HOGAN & HARTSON
K802783 12/16/1980 SURGEONS CHOICE STAPLE, REMOVE/IMPLANT HOSPITAL PRODUCTS INTL.
K802872 12/11/1980 AUFRANC-TURNER ATS TOTAL HIP SYSTEM HOWMEDICA CORP.
K802124 12/01/1980 GRISTINA GLENOID PROSTHESIS HOWMEDICA CORP.
K802106 12/17/1980 LEWIS TRAPEZO METACARPAL PROSTHESIS HOWMEDICA CORP.
K802922 12/17/1980 POROUS COATED ANATOMICAL-TOTAL KNEE HOWMEDICA CORP.
K801970 12/31/1980 UCLA SHOULDER HOWMEDICA CORP.
K802601 12/18/1980 ENDOTRACHEAL TUBE HOLDER HUDSON OXYGEN THERAPY SALES CO.
K803063 12/22/1980 STRAP EASE 400 INDEPENDENT TRANSFER EQUIPMENT CO.
K802973 12/19/1980 ISPVAC TM INNOVATIVE SURGICAL PRODUCTS INC.
K802865 12/18/1980 SAFE T COUNT INSTRANETICS, INC.
K801172 12/01/1980 INTERMEDICS' LIFELINE TLE ENDOCARDIAL INTERMEDICS, INC.
K802976 12/19/1980 CARBONACRYL IPOS LUNEBURG
K802977 12/19/1980 IPOCARBON STRETCH STOCKINETTE IPOS LUNEBURG
K802997 12/22/1980 HDL-CHOLESTEROL CONTROL SERUM ISOLAB, INC.
K803082 12/22/1980 ADHESIVE PERISTOMAL COVERING W/WO CONN. JOHNSON & JOHNSON PROFESSIONALS, INC.
K802967 12/30/1980 DISPERSALLOY-DISPERSED PHASE ALLOY SELF- JOHNSON & JOHNSON PROFESSIONALS, INC.
K802411 12/16/1980 BLOOD PRESSURE UNIT MODEL 310 JS & A GROUP
K802412 12/16/1980 BLOOD PRESSURE UNIT MODEL 410 JS & A GROUP
K802228 12/09/1980 BIOLOGICAL INDICATOR - KEMMED & BIOSURE KEM MEDICAL PRODUCTS CORP.
K802229 12/09/1980 CHEMICAL INDICATOR - KEM MED & BIO SURE KEM MEDICAL PRODUCTS CORP.
K802870 12/17/1980 RION ELECTRO-PALATOGRAPH MODEL DP-01 KINDEL & ANDERSON
K803050 12/30/1980 SPRAY, SYNTHETIC SMEAR LABORATORY PRODUCTS, INC.
K801535 12/16/1980 LARES HANDPIECE OIL LARES MANUFACTURING CO., INC.
K802781 12/10/1980 BEDDING PADS "EGGCREATE" PADS LEEMART BEDDING MFG. CO.
K802925 12/19/1980 6-415 FILTER, ELEMENT, 170-C LIFECARE SERVICES, INC.
K802914 12/19/1980 6-435 FILTER PAD, 5/PKG. LIFECARE SERVICES, INC.
K803004 12/22/1980 AMINO ACID ANALYSER SYSTEM LKB INSTRUMENTS, INC.
K802983 12/30/1980 THE INQUINAL RESORVOIR INSERTER LONE STAR MEDICAL PRODUCTS, INC.
K802181 12/31/1980 WISCONSIN BONE MINERAL ANALYZER LUNAR RADIATION CORP.
K802180 12/31/1980 WISCONSIN DUAL-PHOTON BONE ANALYZER LUNAR RADIATION CORP.
K802508 12/18/1980 RUBELISA IGM TEST KIT M.A. BIOPRODUCTS
K802823 12/11/1980 CHOLESTEROL STANDARDS MALLINCKRODT CRITICAL CARE
K802825 12/11/1980 COMBINED GLUCOSE AND BUN STANDARDS MALLINCKRODT CRITICAL CARE
K802824 12/11/1980 COMBUNED CALCIUM AND PHOSPHORUS STD. MALLINCKRODT CRITICAL CARE
K802836 12/11/1980 SERIES 1800 EXERCISE TREADMILL MARQUETTE ELECTRONICS, INC.
K801672 12/18/1980 MEDCOMP SUBCLAVIAN CATHETER MEDICAL COMPONENTS, INC.
K801284 12/01/1980 LOW PROFILE LEAD CONNECTOR MODIFICATION (4002) MEDTRONIC VASCULAR KEITH J PROCTOR
K802355 12/17/1980 METRICON #120 FLUOROPHOTOMETER METRICON, LTD.
K802743 12/10/1980 AMES SERA-PAK CHOLESTEROL REAGENT KIT MILES LABORATORIES, INC.
K802724 12/10/1980 AMES SERA-PAK URIC ACID REAGENT KIT MILES LABORATORIES, INC.
K803107 12/22/1980 AMES TDA AMIKACIN CONTROL SERUM MILES LABORATORIES, INC.
K802742 12/11/1980 SERA-PAK TOTAL PROTEIN REAGENT MILES LABORATORIES, INC.
K803019 12/22/1980 SERALYZER LDH REAGENT STRIPS, CALIBR MILES LABORATORIES, INC.
K802830 12/10/1980 MILLAR MIKRO-TIP CATHETER PHONOTRANS MILLAR INSTRUMENTS, INC.
K802351 12/17/1980 F110 PHOTO BINOCULAR OPHTHALMOSCOPE MINAMI, TOMINE & LEW
K802962 12/22/1980 CHEM-ASSAY STANDARD-CONTROLS NATIONAL BIO-TECHNICAL LABORATORIES
K802484 12/01/1980 SINVISION 2001 ULTRASOUND SCANNER NATIONAL ULTRASOUND CORP.
K802887 12/16/1980 MODEL EEG 4221 NIHON KOHDEN AMERICA, INC.
K802959 12/19/1980 NIKON URINE REFRACTOMER SG-1 NIPPON KOGAKU, INC.
K802945 12/19/1980 PRESSURE MONITORING SET NORTON PERFORMANCE PLASTICS CORP.
K802955 12/19/1980 MONITOR, AIRWAY PRESSURE NOVAMETRIX MEDICAL SYSTEMS, INC.
K802702 12/10/1980 NEONATAL PHOTOTHERAPY UNIT OHIO MEDICAL PRODUCTS
K802114 12/18/1980 NEPHROSS DIALYZER ORGANON TEKNIKA CORP.
K802693 12/10/1980 OREIA-Q-TY, ENZYME IMMUNOASSAY ORGANON, INC.
K802974 12/19/1980 RAPI-DOT ORGANON, INC.
K802634 12/11/1980 STERIGAGE EO ETHYL. OXIDE STERIL. INDIC. ORGANON, INC.
K802929 12/31/1980 ADENO VIRUS & CONTROLS ORION DIAGNOSTICA, INC.
K802939 12/31/1980 HERPES SIMPLEX TYPE I ORION DIAGNOSTICA, INC.
K802932 12/31/1980 MEASLES VIRUS & CONTROLS ORION DIAGNOSTICA, INC.
K802933 12/31/1980 MUMPS S & V ANTIGENS & CONTROLS ORION DIAGNOSTICA, INC.
K802946 12/22/1980 MYCOLOGY CULTURE SYSTEM ORION DIAGNOSTICA, INC.
K802934 12/31/1980 MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL ORION DIAGNOSTICA, INC.
K802947 12/22/1980 ORICULT DTM ORION DIAGNOSTICA, INC.
K802935 12/31/1980 PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR ORION DIAGNOSTICA, INC.
K802936 12/31/1980 RESPIRATORY SYNCYTIAL VIRUS ANTIGEN & ORION DIAGNOSTICA, INC.
K802937 12/31/1980 RUBELLA VIRUS ANTIGENS & CONTROLS ORION DIAGNOSTICA, INC.
K802938 12/31/1980 VARICELLA-ZOSTER ANTIGENS & CONTROLS ORION DIAGNOSTICA, INC.
K803073 12/31/1980 ORTHO HEMATOLOGY CONTROL ORTHO INSTRUMENTS
K803084 12/31/1980 ORTHO HEMATOLOGY CONTROL ABNORMAL LOW ORTHO INSTRUMENTS
K803083 12/31/1980 ORTHO HEMOTOLOGY CONTROL-NORMAL ORTHO INSTRUMENTS
K802911 12/17/1980 A/K SOCKET ORTHOMEDICS
K803033 12/22/1980 CRUSADER HYPEREXTENSION BRACE ORTHOMEDICS
K802909 12/17/1980 HUMERAL FRACTURE BRACE ORTHOMEDICS
K802910 12/22/1980 PLASTIC FRACTURE CAST BRACE KNEE JOINT ORTHOMEDICS
K802871 12/11/1980 TIBIAL FRACTURE BRACE ORTHOMEDICS
K802908 12/17/1980 ULNAR FRACTURE BRACE ORTHOMEDICS
K803029 12/22/1980 TLC SUPPORT PRODUCTS ORTHOPEDIC SYSTEMS, INC.
K803021 12/12/1980 UPPER EXTREMITY TRACTION DEVICE ORTHOPEDIC SYSTEMS, INC.
K802753 12/11/1980 CAMPYLOBACTER SELECTIVE SUPPLEMENT (BL.) OXOID U.S.A., INC.
K802495 12/18/1980 CLOSTRIDIUM DIFFICILE AGAR BASE OXOID U.S.A., INC.
K802593 12/22/1980 KERATOPLASTY SUTURING LENS PARIS CONTACT LENS LABORATORY
K803092 12/22/1980 MIC-BIOPLATE INOCULATOR PASCO LABORATORIES, INC.
K803047 12/22/1980 I-125 LABELED DIGOXIN PCL-RIA, INC.
K802529 12/18/1980 PFIZONIC 100 ULTRASOUND SCANNER PFIZER MEDICAL SYSTEMS, INC.
K802528 12/18/1980 PFIZONIC 150 ULTRASOUND SCANNER PFIZER MEDICAL SYSTEMS, INC.
K802531 12/18/1980 PFIZONIC 200 ULTRASOUND SCANNER PFIZER MEDICAL SYSTEMS, INC.
K802530 12/18/1980 PFIZONIC 250 ULTRASOUND SCANNER PFIZER MEDICAL SYSTEMS, INC.
K802532 12/18/1980 PFIZONIC 300 ULTRASOUND SCANNER PFIZER MEDICAL SYSTEMS, INC.
K802556 12/02/1980 PHADEBAS RAST TEST PHARMACIA, INC.
K802897 12/16/1980 ELECTRONIC DIGITAL THERMOMETER PHILIP J. TEDERS
K802578 12/18/1980 PACE-4-AUTOMATIC RIA GAMMA-COUTER PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K802779 12/10/1980 LOAD SENTINEL II, TRANS. ELEC. NERVE POWERS MEDICAL SYSTMES
K802400 12/16/1980 MS 16 SYRINGE DRIVER PRINCETON MEDICAL INSTRUMENTS, INC.
K802813 12/17/1980 PMR-2 PURITAN MANUAL RESUSCITATOR PURITAN BENNETT CORP.
K802268 12/31/1980 CRC(CYANMETHEMOGLOBIN REAGENT CONCENT R & D SYSTEMS, INC.
K802892 12/11/1980 CULTURE MEDIA FOR IN VITRO DIAG. USE RADIATION TECHNOLOGY, INC.
K802571 12/16/1980 CYE BIPHASIC BLOOD CULTURE MEDIUM REMEL CO.
K803054 12/22/1980 SAF FIXATIVE REMEL CO.
K802758 12/31/1980 SELECTIVE CHARCOAL YEAST EXTRACT AGAR REMEL CO.
K802873 12/19/1980 SHEA LOCKING BAIL PROSTHESIS RICHARD'S MEDICAL EQUIP., INC.
K802749 12/17/1980 BLENDED BIFOCAL ROBINSON-HOUCHIN, INC.
K802658 12/30/1980 RODEL ELECTRODERM PADS RODEL PRODUCTS CORP.
K802780 12/10/1980 JACKSON HYDRO SYSTEM S. JACKSON, INC.
K802994 12/22/1980 TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL SACKS FARMS BIOLOGICAL PRODUCTS
K802995 12/22/1980 TRYPTICASE SOY AGAR W/5% SHEEP BLD. CELL SACKS FARMS BIOLOGICAL PRODUCTS
K802926 12/19/1980 SCI-PHARM UNIVERSAL CAVITY VARNISH SCIENTIFIC PHARMACEUTICALS, INC.
K802792 12/10/1980 CELLONA SECOL CO.
K802785 12/11/1980 ELASTIC BANDAGE SECOL CO.
K802784 12/10/1980 ELASTIC OPEN WEAVE BANDAGE SECOL CO.
K802799 12/17/1980 EYE PADS SECOL CO.
K802793 12/18/1980 LOMATUELL OINTMENT DRESSING SECOL CO.
K802787 12/17/1980 METALLINE DRESSINGS SECOL CO.
K802797 12/17/1980 O.R. DRAPES SECOL CO.
K802798 12/11/1980 OPRATEX ABDOMINAL PAD SECOL CO.
K802795 12/10/1980 ORTHOPEDIC PADDING SECOL CO.
K802786 12/17/1980 POROPLAST-EYE DRESSING SECOL CO.
K802794 12/22/1980 PRO-OPHTA STICKS SECOL CO.
K802789 12/10/1980 TUBULAR BANDAGE SECOL CO.
K802791 12/17/1980 ZINC PASTE BANDAGE SECOL CO.
K802667 12/16/1980 ARGYLE CLOSED URINARY DRAINAGE SET SHERWOOD MEDICAL CO.
K802777 12/11/1980 ARGYLE CONNECT TUBE-CON & NON SHERWOOD MEDICAL CO.
K802891 12/19/1980 ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT SHERWOOD MEDICAL CO.
K802875 12/16/1980 ARGYLE HEMATURIA BALLOON CATHETER SHERWOOD MEDICAL CO.
K802692 12/10/1980 LANCER URIC ACID AUTO/STAT KIT SHERWOOD MEDICAL CO.
K802879 12/19/1980 BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL. SHILEY, INC.
K801879 12/16/1980 PUIG MASSANA-SHILEY ANNULOPLASTY RING SHILEY, INC.
K803012 12/30/1980 SHUR-PATCH TAPE PATCH SHUR MEDICAL CORP.
K803042 12/22/1980 SIEMENS-ELEMA ENDOCARDIAL LEAD 402S SIEMENS ELEMA AB
K801324 12/01/1980 SIEMENS-ELEMA PULSE GENERATOR 668 SIEMENS ELEMA AB
K802721 12/11/1980 GLYCOHEMOGLOBIN IN WHOLE BLOOD SIGMA CHEMICAL CO.
K802341 12/10/1980 DIOSCAN SONOMETRICS SYSTEMS, INC.
K803011 12/31/1980 DISPOSABLE DIAPHRAGM DONE SORENSEN RESEARCH
K802961 12/31/1980 TRANSDUCER DOME, CAT.#SD-101 SORENSEN RESEARCH
K802982 12/19/1980 GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG. STANFORD LABORATORIES
K802636 12/11/1980 PLATELET COUNTING KIT STRECK LABORATORIES, INC.
K802868 12/19/1980 ACCU-COUNTER SURGICAL SPONGE COUNTING SY SURGICAL SYSTEMS, INC.
K802987 12/30/1980 JOTA DIAMOND DENTAL BURS SWISS AMERICAN METAL CRAFT CORP.
K802988 12/30/1980 JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS SWISS AMERICAN METAL CRAFT CORP.
K802984 12/30/1980 MEISINGER DIAMOND DENTAL BURS SWISS AMERICAN METAL CRAFT CORP.
K802989 12/30/1980 MEISINGER TUNGSTEN CARBIDE & STEEL DT.B. SWISS AMERICAN METAL CRAFT CORP.
K802827 12/11/1980 BOUIE ELECTROSURGICAL TIP CLEANER SYBRON CORP.
K802452 12/18/1980 TOXOTEST-MT EIKEN KIT SYN-KIT, INC.
K802462 12/16/1980 SYNTHES SPINAL IMPLANT SYSTEM SYNTHES (USA)
K803077 12/05/1980 BIOLUMIN. SCREENING FOR BACT. BY ATP A. TECHNOLOGY, INC.
K802849 12/16/1980 TECNOL TELEMETRY UNIT POUCH TECNOL NEW JERSEY WOUND CARE, INC.
K802968 12/22/1980 UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC TELECTRONICS, INC.
K802441 12/18/1980 CLIRANS TH10 HOLLOW FIBER DIALYZER TERUMO AMERICA, INC.
K802122 12/18/1980 CLIRANS TH13 HOLLOW FIBER DIALYZER TERUMO AMERICA, INC.
K802833 12/10/1980 TETRA NATAL-MAT WATER FLOTATION MAT. TETRA GROUP U.S.A., INC.
K802846 12/17/1980 TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY. THE LONDON CO.
K802820 12/10/1980 TRAVENOL 24 HR. INFUSOR (ELASTOMERIC PP) TRAVENOL LABORATORIES, S.A.
K802901 12/17/1980 TRAVENOL INFUSION PUMP-2M8016 TRAVENOL LABORATORIES, S.A.
K802054 12/01/1980 TRAVENOL ULTRASONIC NEBULIZER CUPS TRAVENOL LABORATORIES, S.A.
K802474 12/15/1980 CMR 300, ROWATER TREATMENT UNIT U-MARC, INC.
K802741 12/10/1980 CENTRIFICHEM COMB. SERUM-BASED CALIB. UNION CARBIDE CORP.
K803048 12/22/1980 VANCE UROSTOMY APPLIANCE VANCE PRODUCTS, INC.
K802725 12/11/1980 VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS VARIAN ASSOC., INC.
K802986 12/22/1980 POWERED WHEELCHAIR VESSA LTD.
K802279 12/15/1980 VIDA 55 PULSE-ECHO ULTRASONIC DEVICE VIDA, INC.
K802679 12/17/1980 SILANIT VIVADENT (USA), INC.
K802535 12/18/1980 HYDROXYLATE DENTAL COMPOSITE RESTROATIVE WALLACE A. ERICKSON & CO.
K803201 12/17/1980 LEMON GLYCERINE SWABS WALPAK CO.
K803053 12/22/1980 APEXLINE OF PULMONARY FUNCT. INSTRUM. WARREN E. COLLINS, INC.
K803069 12/22/1980 SHELL KRATON THERMO-PLASTIC RUBBER COMP. WARREN E. COLLINS, INC.
K802728 12/11/1980 125I-TESTOSTERONE TEST SET WIEN LABORATORIES, INC.
K803165 12/31/1980 ACETABULAR CEMENT COMPRESSOR ZIMMER, INC.
K803064 12/31/1980 ZIMMER ELECTRICAL MUSCLE STIMULATOR ZIMMER, INC.
K802899 12/19/1980 CERAMIBOND ZULAUF, INC.


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