FDA 510(k) Decisions During January, 1978  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K780028 01/17/1978 ORTHODONTIC. PLASTIC BRACKET PRIMER 3M COMPANY
K781504 11/22/1978 125I-ALDOSTERONE RIA DIAG. KIT ABBOTT LABORATORIES
K771972 01/03/1978 5UM FILTERSET WITH Y-INJECTION SITE ABBOTT LABORATORIES
K772312 01/26/1978 FILTERSET W/Y-INJECTION SITE, 0.2 ABBOTT LABORATORIES
K781770 11/15/1978 SKIN MARKING PEN ABCO DEALERS, INC.
K781841 11/08/1978 BAR, DISTRACTION ACE ORTHOPEDIC MANUFACTURING CO.
K781839 11/08/1978 BONE CLAMP, ACE EXTERNAL ACE ORTHOPEDIC MANUFACTURING CO.
K781840 11/08/1978 EXTERNAL ARTICULATION ACE ORTHOPEDIC MANUFACTURING CO.
K780060 01/26/1978 CAMERA, GAMMA ACKERMAN-SCHMEHL INDUSTRIES, INC.
K781672 11/08/1978 ACU-DOT ACU-DOT PHARMACEUTICAL INTL., INC.
K772173 01/24/1978 STETHOSCOPE, ELECTRONIC AFFILIATED MAILORDER CO. SALES, INC.
K772228 01/03/1978 ALSITE MAGNIVISION AL NYMAN & SON, INC.
K781765 11/22/1978 LDH REAGENT SYSTEM AMERICAN MONITOR CORP.
K781845 11/20/1978 CAMSCAN SYSTEM AMERICAN OPTICAL CORP.
K781698 11/03/1978 EXAMINER 10 AMERICAN STERILIZER CO.
K772324 01/03/1978 WIREDRIVER AMERICAN STERILIZER CO.
K781667 11/03/1978 AMPLAID MARK 4 AND MARK 5 AMPLAID USA, INC.
K781856 11/22/1978 PLATE, LD PRESUMPTO ANAEROBE SYSTEMS
K781654 11/08/1978 NEPHELRATE ANTIPERUMS LGM ANTIBODIES INC.
K781655 11/08/1978 NEPHELRATE ANTISERUMS 1GA ANTIBODIES INC.
K781653 11/08/1978 NEPHELRATE ANTISERUMS C3C ANTIBODIES INC.
K781656 11/08/1978 NEPHELRATE ANTISERUMS, IGG ANTIBODIES INC.
K780128 01/31/1978 BLOOD PRESSURE MONITOR, ARTERIAL APPLIED MEDICAL RESEARCH
K780127 01/31/1978 DINAMAP MODEL 850 APPLIED MEDICAL RESEARCH
K771981 01/24/1978 MINIMAP MODEL 810 APPLIED MEDICAL RESEARCH
K781847 11/03/1978 LATEX, IN-HOUSE COMPOUNDED ARBROOK MFG. CORP.
K772369 01/24/1978 NEEDLES USED IN ANGIOGRAPHIC PROCED. ARGON MEDICAL CORP.
K772366 01/26/1978 BAG, DRAINAGEW/ADHESIVE; PROSTHESIS ATLANTIC SURGICAL
K772141 01/03/1978 AEROSOL & OXYGEN MASKS B & F MEDICAL PRODUCTS, INC.
K781793 11/03/1978 FRAME, UNIVERSAL DAY B.G. ORTHOPEDIC CORP.
K780053 01/17/1978 BRACE, TENNIS ELBOW BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781674 11/15/1978 MACRO-VUE TEST, GENTAMICIN BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781662 11/08/1978 RIA, T3 UPTAKE SOLID PHASE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K772330 01/12/1978 T4 RIA KIT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780573 11/07/1978 TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780040 01/31/1978 ALANINE TRANSAMINASE BECKMAN INSTRUMENTS, INC.
K780039 01/31/1978 ASPARTATE TRANSAMINASE BECKMAN INSTRUMENTS, INC.
K781842 11/08/1978 OXYGENATOR, BLOOD BOS-10 BENTLEY LABORATORIES, INC.
K772423 01/26/1978 SPIRAFLOW DIALYZERS BENTLEY LABORATORIES, INC.
K771983 01/05/1978 SCALP VEIN SET BERMAN, PCP & CONSULTANTS, INC.
K781786 11/15/1978 QUANTICEL HHR # L500 AND L501 BHP DIAGNOSTIX, INC.
K781745 11/15/1978 QUANTICEL HHR, L531 AND L532 BHP DIAGNOSTIX, INC.
K772358 01/30/1978 ETHYLENE OXIDE STERILI. INDICATOR BIO-MEDICAL SCIENCES, INC.
K781702 11/15/1978 CALIBRATOR, BOVINE SERUM BIO-REAGENTS & DIAGNOSTICS, INC.
K772221 01/30/1978 LENS, HARD RESIN BORANI INTL.
K781838 11/21/1978 CALCULATOR, WITH CHARGER C.R. BARD, INC.
K781954 11/29/1978 CATHETER INTRODUCERS, ARTERISE C.R. BARD, INC.
K781736 11/03/1978 DISC, COLOPLAST PRE-OP STOMA C.R. BARD, INC.
K772296 01/17/1978 INSPIRON MANIFOLD C.R. BARD, INC.
K772294 01/17/1978 INSPIRON MANIFOLD (DOUBLE) C.R. BARD, INC.
K772295 01/17/1978 INSPIRON MANIFOLD (SINGLE) C.R. BARD, INC.
K772338 01/26/1978 SYRINGE, BLOOD, SAMPLING, ARTERIAL C.R. BARD, INC.
K780032 01/17/1978 URINARY LEG BAG C.R. BARD, INC.
K771933 01/26/1978 CILCO ANTERIOR CHAMBER LENS CALIFORNIA INTRAOCULAR LENS
K772241 01/30/1978 PULSE GENERATOR, BIPOLAR, DEMAND CARDIAC PACEMAKERS, INC.
K772239 01/30/1978 PULSE GENERATOR, BIPOLAR, PROGRAMMABLE CARDIAC PACEMAKERS, INC.
K772240 01/30/1978 PULSE GENERATOR, UNIPOLAR, DEMAND CARDIAC PACEMAKERS, INC.
K772238 01/30/1978 PULSE GENERATOR, UNIPOLAR, PROGRAMABLE CARDIAC PACEMAKERS, INC.
K781911 11/30/1978 ECG ANALYZER, HIGH SPEED CARDIO-DYNAMICS LABORATORIES, INC.
K781932 11/29/1978 BLOOD PRESSURE RECORDER CARDIODYNE, INC.
K772351 01/17/1978 DENTAL LIGHT CHEMETRON DENTAL PRODUCTS
K781833 11/14/1978 EXERCISER, AIR-EZE INCENTIVE CHESEBROUGH-POND'S U.S.A. CO.
K781807 11/22/1978 REAGENT, FIREFLY #395 CHRONO-LOG CORP.
K771415 01/05/1978 RIA FOR SERUM THYROXINE CLINICAL IMMUNO-DIAGNOSTICS
K780109 01/31/1978 TILL-U=TEST CLINIFAX INDUSTRIES, LTD.
K781507 11/15/1978 RETINOMETER COBURN OPTICAL IND., INC.
K772355 01/26/1978 BLOOD LINE COMP. NEG. PRESS. PILLOW CORDIS CORP.
K780066 01/30/1978 CARDIAC PACER, MODEL 208 CORDIS CORP.
K772063 01/03/1978 CATHETER, INTRACRANIAL PRESS. MONITOR. CORDIS CORP.
K772194 01/06/1978 IMMO PHASE FT4 ASSAY CORNING MEDICAL & SCIENTIFIC
K781907 11/22/1978 EAR STOPPLES FOR NOISE ATTENTION CROWN DELTA CORP.
K781521 11/22/1978 CUTTER RESIFLEX URINE METER CUTTER LABORATORIES, INC.
K781668 11/03/1978 GAMMA RADIATION STERILIZATION PRECEDURE CUTTER LABORATORIES, INC.
K781480 11/08/1978 ANTITHROMBIN III ASSAY DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K781478 11/15/1978 PLASMINOGEN ASSAY DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K772197 01/30/1978 PACEMAKER, PERM. & TEMP., ELECTRODE DAIG CORP.
K781881 11/15/1978 HEARING AID, MODEL 781 DANAVOX, INC.
K781671 11/16/1978 BLOOD PRESSURE CUFF COVER DAVID COTT CO.
K772315 01/03/1978 KWIKAP DEN-MAT CORP.
K772316 01/03/1978 MATRIX STRIP, DEAD-SOFT DEN-MAT CORP.
K771974 01/12/1978 SOLVENEX I-0 DEN-MAT CORP.
K772314 01/03/1978 WEDGES, RETAINING, MATRIX DEN-MAT CORP.
K772368 01/30/1978 SPECTACLE FRAME, OP-TITE DENTSPLY INTL.
K780052 01/20/1978 PROSTHESIS, DOUBLE CUP DEPUY, INC.
K781754 11/08/1978 SPLINT, HOAKE INFLATABLE AIR DEPUY, INC.
K781791 11/08/1978 BOARD, DISPOSABLE CONTROL COUNT DEXIDE, INC.
K780022 01/20/1978 CULTURE MEDIA/ISOLA. PATHO. NEISSERIA DIAGNOSTIC CULTURE SYSTEM
K772192 01/12/1978 NEONATAL TSH RIA KIT (125I) DIAGNOSTIC PRODUCTS CORP.
K772191 01/12/1978 TESTOSTERONE RIA KIT (125I) DIAGNOSTIC PRODUCTS CORP.
K772359 01/05/1978 PREGNANCY TEST KIT, ANSWER DIAGNOSTIC TESTING, INC.
K781759 11/27/1978 RESCAL DIEMOLDING CORP.
K781756 11/15/1978 SILASTIC H.P. TRAPEXIAL IMPLANT DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K772322 01/03/1978 DEPILATORY, ELECTRONIC DURA CORP., THE
K772285 01/06/1978 ACA LIPASE VERIFIERS E.I. DUPONT DE NEMOURS & CO., INC.
K772396 01/17/1978 ALLIGATOR CUP FORCEPS EDWARD WECK, INC.
K772392 01/17/1978 ALLPORT MASTOID RETRACTORS EDWARD WECK, INC.
K772370 01/17/1978 BARRAQUER OVAL SPECULUM-VARIOUS SIZES EDWARD WECK, INC.
K772371 01/06/1978 BAYONET SURGICAL INSTRUMENTS EDWARD WECK, INC.
K772391 01/17/1978 BOIES NASAL FRACTURE ELEVATOR EDWARD WECK, INC.
K772388 01/20/1978 CONVERSE-GILLIES NEEDLE HOLDER EDWARD WECK, INC.
K772397 01/17/1978 COTTLE COLUMELLA FORCEP EDWARD WECK, INC.
K772398 01/17/1978 COTTLE LOWER LATERAL FORCEPS EDWARD WECK, INC.
K772389 01/06/1978 DANDY HEMOSTATIC FORCEPS EDWARD WECK, INC.
K772390 01/17/1978 DAY EAR HOOK EDWARD WECK, INC.
K772399 01/17/1978 DINGMAN ZYGOMA ELEVATOR EDWARD WECK, INC.
K772380 01/17/1978 FARRIOR OVAL SPECULUM EDWARD WECK, INC.
K772377 01/17/1978 HILDYARD POST NASAL FORCEP EDWARD WECK, INC.
K772384 01/17/1978 MYRINGOTOMY KNIFE EDWARD WECK, INC.
K772381 01/17/1978 RING HANDLE & RETRACTORS EDWARD WECK, INC.
K772372 01/17/1978 ROLLER KNIFE EDWARD WECK, INC.
K772385 01/17/1978 THIN-BLADED NASAL SPECULUM EDWARD WECK, INC.
K780091 01/30/1978 MICROPULSE 22U EDWARDS PACEMAKER SYSTEMS
K770999 01/12/1978 LITTON 300L ULTRASOUND SYSTEM ELECTRA-PHYSICS LABORATORIES, INC.
K772143 01/10/1978 GENERATOR ELECTRIC FIELD TECHNOLOGY CORP.
K780045 01/24/1978 ELECTRODE CAP ELECTRO-CAP INTL., INC.
K780107 01/30/1978 ANALYZER-PLUG-IN, CO2 MODEL M 3104 ELECTRONICS FOR MEDICINE, INC.
K780027 01/26/1978 ACCELERATOR, LINEAR, MED. EMI THERAPY SYSTEMS, INC.
K771817 01/13/1978 EMI THERAPY SIMULATOR EMI THERAPY SYSTEMS, INC.
K780819 11/07/1978 GLYCOHEMOGLOBIN-SKREEN TEST KIT EPPENDORF-BRINKMANN, INC.
K772337 01/12/1978 URINARY 17-KETOSTERIOD/17 EPPENDORF-BRINKMANN, INC.
K781863 11/06/1978 DEVICE, FEMALE INCONTINENCE ESCHMANN BROS. & WALSH LTD.
K781670 11/07/1978 STIMULATOR, E.S.I. NEURO EVOLUTIONARY SYSTEMS, INC.
K781522 11/08/1978 THE VISUAL SPEECH AID EXETER MEDICAL LABS, INC.
K781740 11/22/1978 REAGENT, HDL FISHER SCIENTIFIC CO., LLC.
K772406 01/06/1978 AESTHESIOMETER FRED SAMMONS, INC.
K780085 01/30/1978 CANE/REACHER FRED SAMMONS, INC.
K772415 01/05/1978 DYNAMETER 50 LB. FRED SAMMONS, INC.
K772419 01/26/1978 HEEL OR ELBOW PROTECTOR FRED SAMMONS, INC.
K772401 01/05/1978 LAP BOARD W/RIM FRED SAMMONS, INC.
K772413 01/05/1978 PINCH GUAGE FRED SAMMONS, INC.
K772411 01/05/1978 PLATFORM SPLINTS FRED SAMMONS, INC.
K772416 01/05/1978 PRE-FORMED SPLINT BLANKS FRED SAMMONS, INC.
K772402 01/26/1978 QUADRIPLEGIC URINARY DRAINAGE VALVE FRED SAMMONS, INC.
K772420 01/05/1978 REAR FASTENING SAFETY STRAP FRED SAMMONS, INC.
K772410 01/05/1978 RESTING PAN SPLINTS FRED SAMMONS, INC.
K772417 01/05/1978 SLIDING BOARD FRED SAMMONS, INC.
K772405 01/26/1978 TUBING CLAMP FRED SAMMONS, INC.
K772421 01/05/1978 WHEELCHAIR BELT FRED SAMMONS, INC.
K772361 01/30/1978 LASER IMMUNONEPHELOMETRIC ANALYZER G.D. SEARLE AND CO.
K772325 01/12/1978 DENSITOMETER 18, COMPUTING, AUTO. GELMAN INSTRUMENT CO.
K772304 01/03/1978 DENTAL IMPLANT, CARBON COATED METAL GENERAL ATOMIC CO.
K781814 11/08/1978 SULFATE, FIBRIQUIK PROTAMINE GENERAL DIAGNOSTICS
K772360 01/12/1978 ARRHYTHMIA MODULE GENERAL ELECTRIC CO.
K772317 01/11/1978 CT/T SYSTEM MODEL B7800A GENERAL ELECTRIC CO.
K781571 11/27/1978 L/U ARM-VASCULAR GENERAL ELECTRIC CO.
K772139 01/05/1978 RE-CELL SLIDE RECAP GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K772288 01/30/1978 CATHETER, CHOLANGIOGRAM, OPERATIVE GESCO INTL., INC.
K781773 11/22/1978 ALBUMIN REAGENT GILFORD DIAGNOSTICS
K781775 11/22/1978 LDH GILFORD DIAGNOSTICS
K781774 11/22/1978 TOTAL PROTEIN GILFORD DIAGNOSTICS
K772319 01/12/1978 ANALYZER, CLINICAL, SYSTEM 3 GILFORD INSTRUMENT LABORATORIES, INC.
K772344 01/31/1978 DATA ACQUISITION & COLLATING SYS. GILFORD INSTRUMENT LABORATORIES, INC.
K772258 01/05/1978 CLINICARD CK-II HARLECO
K781940 11/29/1978 EKG ELECTRODES, DISPOSABLE HAYES PRODUCTS, INC.
K772346 01/11/1978 PHONIC MIRROR HANDIVOCIE MODEL 110 HC ELECTRONICS
K772347 01/11/1978 PHONIC MIRROR HANDIVOICE MODEL 120 HC ELECTRONICS
K772161 01/03/1978 HEMODIALYSIS APPARATUS HEALD MANUFACTURING, INC.
K781530 11/14/1978 TEMPERATURE CONTROLLER MODEL 17000 HEALTHDYNE, INC.
K781471 11/08/1978 PNEUMATIC VITRECTOMY CONTROL UNIT HELFGOTT MEDICAL INSTRUMENTS
K772364 01/05/1978 AUTO. SAMPLING SYSTEM HEWLETT-PACKARD CO.
K772234 01/05/1978 CARDIAC OUTPUT MODULE-78231C HEWLETT-PACKARD CO.
K781891 11/15/1978 PIPETTES, PLASTIC DISPOSABLE HILLWOOD CORP.
K781768 11/14/1978 CATHETERS, H-H ATRIAL AND PERITONEAL HOLTER-HAUSNER INTL.
K780017 01/30/1978 AUTO. SLIDE STAINER HONEYWELL, INC.
K772367 01/11/1978 CHEST BELLOWS, SMALL HONEYWELL, INC.
K781908 11/27/1978 BREATHING CIRCUIT PRODUCTS, ANESTHESIA HOSPITAK, INC.
K781843 11/03/1978 RECORDER, HOLTER ELECTROCARDIOGRAM HOVIK CORP.
K771016 01/12/1978 INTERMEDULLARY BRUSH HOWMEDICA CORP.
K781837 11/15/1978 WOUND SPAN BRIDGE III HOWMEDICA CORP.
K772216 01/05/1978 PORT-A-BOUT 240 HUDSON OXYGEN THERAPY SALES CO.
K772426 01/30/1978 17-HYDROXY TEST HYCEL, INC.
K772084 01/24/1978 LAS-R HUMAN C3 PROACTIVATOR TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K772085 01/24/1978 LAS-R HUMAN PLASMINOGEN TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K772219 01/20/1978 FIAX TEST FOR ANTI-RUBELLA ANTIBODY IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS
K781589 11/22/1978 VOLUMETRIC CONTROLLER MODEL 310 IMED CORP.
K771977 01/03/1978 CARDIAC OUTPUT COMPUTER MODEL 701 INSTRUMENTATION LABORATORY CO.
K771953 01/20/1978 GASTRIN RIA MODULE INTER SCIENCE INSTITUTE
K771948 01/20/1978 GLUCAGON RIA MODULE INTER SCIENCE INSTITUTE
K771947 01/20/1978 INSULIN RIA MODULE INTER SCIENCE INSTITUTE
K772353 01/06/1978 EKG ACQUISITION & ANALYSIS CART INTL. BUSINESS MACHINES
K781851 11/07/1978 HEMOGLOBIN, TESTING SYSTEM ISOLAB, INC.
K772230 01/03/1978 CANNULA, PERFUSION, FALLOPIAN TUBE J. SKLAR MFG. CO., INC.
K772229 01/03/1978 MINICLAMPS, STABILIZ., FALLOPIAN TUBE J. SKLAR MFG. CO., INC.
K772336 01/26/1978 GLOVE & LATEX FINGER COTS JAMAR HEALTH PRODUCTS
K780020 01/26/1978 GENERATOR, OXYGEN, PORTABLE JET RESEARCH CENTER, INC.
K772256 01/03/1978 CROWN & BRIDGE ALLOY JOHNSON & JOHNSON PROFESSIONALS, INC.
K772278 01/03/1978 FOTOFILL ACTIVATOR LIGHT JOHNSON & JOHNSON PROFESSIONALS, INC.
K772279 01/03/1978 FOTOFILL DENTAL RESTORATIVE JOHNSON & JOHNSON PROFESSIONALS, INC.
K772255 01/05/1978 CERULOPLASMIN NEPHEL. ASSAY KALLESTAD LABORATORIES, INC.
K772345 01/05/1978 FLUORESCEIN CONJUG. FRACT. MONO. ANTI. KALLESTAD LABORATORIES, INC.
K781866 11/15/1978 CANNULA CADDY KATENA PRODUCTS, INC.
K781689 11/15/1978 REFLECT IMPRESSION MATERIAL KERR CORPORATION (DANBURY)
K780058 01/26/1978 TAMPON, HEAVY DUTY, & STICK KIMBERLY-CLARK CORP.
K772297 01/05/1978 INSUFFLATOR, MODEL G100 & 200 KLI
K780038 01/20/1978 DENTAL HANDPIECE LARES MANUFACTURING CO., INC.
K781433 11/03/1978 AKRON MALE EXTERNAL CATHETER LATEX IND., INC.
K772126 01/03/1978 TEMP. BRIDGE, POSTERIOR 3-UNIT LEE PHARMACEUTICALS
K781461 11/08/1978 MODEL 7320 VISUAL STIMULATOR LIFE-TECH INSTRUMENTS, INC.
K781476 11/15/1978 MULAR GOLD LEAF ELECTRODE MODEL 7501 LIFE-TECH INSTRUMENTS, INC.
K772244 01/20/1978 ILLUMINATED DENTAL HANDPIECE LITTON DENTAL PRODUCTS
K780340 11/27/1978 IMV SYSTEM LKB INSTRUMENTS, INC.
K772204 01/05/1978 EYEGLASS FRAMES LOGO PARIS, INC.
K780013 01/30/1978 SERUM GLUTAMIC OXALOACETIC TRANSAMINASE MACOMB CHEMICAL CO.
K780067 01/20/1978 HEARING AID, BEHIND-THE-EAR MAICO HEARING INSTRUMENTS, INC.
K781869 11/22/1978 DROPPER, CEPTI-SEAL KOH SOLUTION MARION LABORATORIES, INC.
K781868 11/22/1978 DROPPER, CEPTI-SEAL LAVTOPHENOL MARION LABORATORIES, INC.
K781700 11/03/1978 IONOTPHORETIC APPLICATOR MCGHAN MEDICAL CORP.
K781087 11/22/1978 MEDICAL GRADE SILICONE ELASTOMER TUBING MCGHAN MEDICAL CORP.
K781239 11/03/1978 MYO-STIM MED GENERAL
K781906 11/16/1978 BLOOD PRESSURE DEVICE, 400 SERIES MED-TEK CORP.
K781818 11/15/1978 LAPARATOMY SPONGE MEDEN MEDICAL SALES DIVISION
K772266 01/20/1978 INSTRUMENT TRAY MEDFUSION SYSTEMS, INC.
K772260 01/26/1978 TELESCOPING BEDRAILS MEDFUSION SYSTEMS, INC.
K772262 01/26/1978 TRAPEZE BAR KNOCKED DOWN MEDFUSION SYSTEMS, INC.
K772261 01/26/1978 TRAPEZE FLOOR BASE MEDFUSION SYSTEMS, INC.
K781718 11/03/1978 ALP REAGENT SET, ALKALINE PHOSPHATASE MEDICAL ANALYSIS SYSTEMS, INC.
K781719 11/03/1978 CPK REAGENT SET, NAD REDUCTION MEDICAL ANALYSIS SYSTEMS, INC.
K781723 11/03/1978 GLUCOSE HEXOKINASE, AUTO K MEDICAL ANALYSIS SYSTEMS, INC.
K781720 11/03/1978 HBDH ENZYME KINETIC REAGENT SET MEDICAL ANALYSIS SYSTEMS, INC.
K781724 11/03/1978 NAD REDUCTION METHOD, LACTATE PYRIVATE MEDICAL ANALYSIS SYSTEMS, INC.
K781721 11/03/1978 REAGENT SET, CHOLESTEROL MEDICAL ANALYSIS SYSTEMS, INC.
K781726 11/03/1978 REAGENT SET, SGPT SERUM GLUTAMIC MEDICAL ANALYSIS SYSTEMS, INC.
K781722 11/03/1978 REAGENT SET, TOTAL PROTEIN MEDICAL ANALYSIS SYSTEMS, INC.
K781725 11/03/1978 REAGENT SET, U.V. ENZMATIC KINETIC, SGOT MEDICAL ANALYSIS SYSTEMS, INC.
K781829 11/22/1978 NEUROPAC ULTRA II MEDICAL DEVICES, INC.
K781924 11/22/1978 POUCHES AND TUBING, MEDI-SEAL MEDICARE INDUSTRIES, INC.
K781925 11/22/1978 POUCHES, GAS STERILIZATION MEDICARE INDUSTRIES, INC.
K772365 01/26/1978 THERMOMETER SHEATHS MEDLINE INDUSTRIES, INC.
K771786 01/04/1978 CARDIAC PULSE GENERATORS 5982/5983 MEDTRONIC VASCULAR
K780001 01/17/1978 EPIDURAL LEAD - MODEL 3481 MEDTRONIC VASCULAR
K772357 01/17/1978 PULSE GENERATORS MEDTRONIC VASCULAR
K780061 01/24/1978 PULSE GENERATORS, MODELS 5972/5973 MEDTRONIC VASCULAR
K772203 01/11/1978 VENTRICULAR LEADS MEDTRONIC VASCULAR
K771770 01/04/1978 XYREL-RA MODELS 5994/5995 MEDTRONIC VASCULAR
K780996 11/22/1978 RUBELISA TEST KIT MICROBIOLOGICAL ASSOC.
K772095 01/05/1978 HEMAGGLUTINATION INHIBITION TEST MILES LABORATORIES, INC.
K772099 01/26/1978 PRINTER MILES LABORATORIES, INC.
K772236 01/24/1978 FILTER, PERITONEAL DIALY. ADMIN. SET MILLIPORE CORP.
K772038 01/12/1978 KANAMYCIN RIA MONITOR SCIENCE CORP.
K772321 01/03/1978 ARTHROSTRESS MTD, INC.
K772354 01/31/1978 I.V. CATHETER NDM CORP.
K781222 11/08/1978 ACCUSCREEN T4 NEOMETRICS, INC.
K772323 01/05/1978 RIANEN ESTRIOL RIA KIT NEW ENGLAND NUCLEAR
K772425 01/05/1978 RIANEN GENTAMICIN RIA KIT NEW ENGLAND NUCLEAR
K781539 11/03/1978 ISO-CARE KIT NICE-PAK PRODUCTS, INC.
K780048 01/20/1978 AMINOGLYCOSIDE TEST SYSTEM NICHOLS INSTITUTE DIAGNOSTICS
K780004 01/20/1978 GOAT ANTI-INFLUENZA ANTISERA NORTHEAST BIOMEDICAL LABS., INC.
K780005 01/20/1978 GOAT ANTI-INFLUENZA ANTISERA NORTHEAST BIOMEDICAL LABS., INC.
K780006 01/20/1978 GOAT ANTI-INFLUENZA ANTISERA NORTHEAST BIOMEDICAL LABS., INC.
K780007 01/20/1978 GOAT ANTI-INFLUENZA ANTISERA NORTHEAST BIOMEDICAL LABS., INC.
K780008 01/20/1978 GOAT ANTI-INFLUENZA ANTISERA NORTHEAST BIOMEDICAL LABS., INC.
K780010 01/20/1978 GOAT ANTI-RUBELLA ANTISERA NORTHEAST BIOMEDICAL LABS., INC.
K780009 01/20/1978 GUINEA PIG WHOLE SERUM NORTHEAST BIOMEDICAL LABS., INC.
K781714 11/27/1978 PNEUMOGARD MODEL 1230 NOVAMETRIX MEDICAL SYSTEMS, INC.
K780086 01/30/1978 INFUSION APPARATUS, POWERED OHIO MEDICAL PRODUCTS
K780064 01/31/1978 SPIROMETER, MONITORING W/ALARM OHIO MEDICAL PRODUCTS
K772305 01/09/1978 RAD. THERAPY PLANNING SUP. SYS. OHIO NUCLEAR, INC.
K780115 01/30/1978 SCANNERS, TOMOGRAPHIC, COMPUTED OHIO NUCLEAR, INC.
K781696 11/03/1978 COPPER-TRAP OLYMPIC MEDICAL CORP.
K781695 11/01/1978 LUBE-LOK OLYMPIC MEDICAL CORP.
K780063 01/20/1978 RUBENOSTICON ORGANON, INC.
K780002 01/31/1978 ANTITHROMBIN III ASSAY ORTHO DIAGNOSTICS, INC.
K780135 01/31/1978 CEMENT EXTRACTION INSTRUMENT SET ORTHOPEDIC EQUIPMENT CO., INC.
K772051 01/30/1978 MDL-201 PACESETTER SYSTEMS
K772050 01/30/1978 TDL-100 B PACESETTER SYSTEMS
K781752 11/03/1978 SCANNER, CT 0450 PFIZER MEDICAL SYSTEMS, INC.
K781797 11/08/1978 PREP TRAY, PREOPERATIVE SKIN PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K772320 01/03/1978 EMERGENCY CART PHYSIO-CONTROL CORP.
K780082 01/24/1978 PERITONEAL DIALYSIS ADMIN. SET PHYSIO-CONTROL CORP.
K781852 11/15/1978 GLOVE, SUPERFLEX MOLDED PINNACLE DISTRIBUTORS, INC.
K781808 11/29/1978 SLICK SET, CUFFED POLAMEDCO, INC.
K780036 01/24/1978 TOWEL, DRAPE, BOUNDARY PROCTER & GAMBLE MFG. CO.
K781545 11/15/1978 AIR POWERED DENTAL HANDPIECE PROMIDENT MFG., LTD.
K771425 01/03/1978 A-V SHUNT EXTENSION QUINTON, INC.
K771422 01/03/1978 PATIENT BY-PASS QUINTON, INC.
K771482 01/03/1978 RINSE BLOCK CONNECTOR QUINTON, INC.
K780076 01/24/1978 EPILATOR, ELECTRONIC MODEL SE-2 R. A. FISCHER CO. CORP.
K772293 01/03/1978 BONE MARROW BIOPSY DEVICE RADIATION DEVELOPMENT CO., INC.
K781730 11/22/1978 RIA, CORTISOL KIT RADIOASSAY SYSTEMS LABORATORIES, INC.
K772281 01/06/1978 RSL INSULIN KIT RADIOASSAY SYSTEMS LABORATORIES, INC.
K772348 01/03/1978 NEBULIZER ADAPTER RESPIRATORY CARE, INC.
K772016 01/26/1978 RESPITRACE RESPITRACE CORP.
K780012 01/20/1978 ANTITHROMBIN III RIA RIA DIAGNOSTICS
K772287 01/13/1978 MUSCLE STIMULATOR RICH-MAR CORP.
K780136 01/31/1978 COLLAR, CERVICAL, SPLIT RICHARD'S MEDICAL EQUIP., INC.
K772313 01/30/1978 X-RAY CO-ORDINATOR RINN CORP.
K772300 01/03/1978 DENTAL CHAIR, VANGUARD RITTER CO.
K772171 01/03/1978 EAR PIERCING DEVICE ROBERT C. CAMERON
K780775 11/30/1978 MEDICAL PROTEIN HYDROLYSATE "REVITAL" ROBERTSON RESOURCES, INC.
K781737 11/22/1978 EXTRACTOR, SABIAN FOREIGN BODY SABIAN CORP.
K772127 01/03/1978 OXYGEN MASK, AIR-ENTRAINMENT SALTER LABS
K781779 11/08/1978 SANI-DENT DENTURE CLEANER SANDI-DENT
K780003 01/20/1978 ENDOSOLV E SEPTODONT, INC.
K771114 01/04/1978 NEUTROCIM SEPTODONT, INC.
K772280 01/03/1978 RECEPTAL ATS MEDIASTINAL LINER SORENSEN RESEARCH
K781798 11/03/1978 TINNITUS MASKER STARKEY LABORATORIES, INC.
K781801 11/03/1978 MAXI-CHAIR SURGICAL MECHANICAL RESEARCH, INC.
K781861 11/15/1978 FILTER, EXTRACORPOREAL BLOOD HOLDER SURGIKOS, INC.
K772008 01/03/1978 SCALP VEIN SETS SURU CHEMICALS & PHARMACEUTICALS, LTD.
K772352 01/31/1978 STAC SYSTEM - ADDITIONAL ANALYTES TECHNICON INSTRUMENTS CORP.
K770143 01/30/1978 TQC CALIBRATION REFERENCE FOR PLATELETS TECHNICON INSTRUMENTS CORP.
K772331 01/11/1978 RESTERIL. OF IMPLANT. ELECT. & ADAPTER TELECTRONICS, INC.
K780112 01/30/1978 SPECTROPHOTOMETER, MODEL 5000 THE PERKIN-ELMER CORP.
K780084 01/30/1978 OXYGEN THERAPY KIT THERMADYNE HOLINGS CORP.
K781753 11/03/1978 TOMOGSCANNER 2 TOMOGSCANNER OK LTD.
K781739 11/27/1978 CAMERA, GCA-10A, LOW ENERGY TOSHIBA MEDICAL SYSTEMS
K772318 01/26/1978 DIALYZER STANDARD, CODE 5DM1780 TRAVENOL LABORATORIES, S.A.
K781811 11/08/1978 TRANSFER PAK 4R 9006 TRAVENOL LABORATORIES, S.A.
K780479 11/22/1978 DELTA-FLOW TRI-DELTA INTL.
K780049 01/26/1978 SPECIMEN COLLECTION DEVICE UROL, INC.
K781872 11/27/1978 CLINAC 2500 VARIAN ASSOC., INC.
K780852 11/03/1978 CLINITEX VIS-X ASPIRATING ACCESSORY VARIAN ASSOC., INC.
K781562 11/15/1978 HEMACHECK VICKERS AMERICA MEDICAL CORP.
K771769 01/03/1978 TINNITUS MASKERS, MODELS S564&S574 VICON INSTRUMENT CO.
K781830 11/15/1978 BIOPSY KIT 781101, ASPIRATION VISTA PRODUCTS, INC.
K780732 11/22/1978 PROCAINAMIDE CALIBRATOR KIT VITEK SYSTEMS, INC.
K781889 11/22/1978 COLLINS PEDALMATE 2 WARREN E. COLLINS, INC.
K781692 11/29/1978 CALIBRATOR, DYNAMIC WATERS ASSOC., INC.
K780031 01/20/1978 FLUORESCENCE DETECTOR MODEL 420 WATERS ASSOC., INC.
K772311 01/12/1978 WISP MODEL 710 WATERS ASSOC., INC.
K781561 11/07/1978 ANGIOGRAPHIC GUIDE WIRE WILSON MEDICAL INSTRUMENTS CO.
K772356 01/24/1978 LDH ISOENZYME COLUMN REAGENT SET WORTHINGTON BIOCHEMICAL CORP.
K761138 01/06/1978 FA TISSUE FIXATIVE & WASH SET ZEUS SCIENTIFIC, INC.


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