FDA 510(k) Applications Received During December, 1977

FDA 510(k) Number Submission Date Device Name Applicant Contact
K772312 12/16/1977 FILTERSET W/Y-INJECTION SITE, 0.2 ABBOTT LABORATORIES
K772228 12/06/1977 ALSITE MAGNIVISION AL NYMAN & SON, INC.
K772227 12/06/1977 CATH KIT, SUPERPUBIC AMERICAN HOSPITAL SUPPLY CORP.
K772324 12/19/1977 WIREDRIVER AMERICAN STERILIZER CO.
K772215 12/02/1977 UNCONJUGATED ESTRIOL RIA KIT AMERSHAM CORP.
K772369 12/27/1977 NEEDLES USED IN ANGIOGRAPHIC PROCED. ARGON MEDICAL CORP.
K772366 12/27/1977 BAG, DRAINAGEW/ADHESIVE; PROSTHESIS ATLANTIC SURGICAL
K772330 12/21/1977 T4 RIA KIT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K772423 12/28/1977 SPIRAFLOW DIALYZERS BENTLEY LABORATORIES, INC.
K772358 12/27/1977 ETHYLENE OXIDE STERILI. INDICATOR BIO-MEDICAL SCIENCES, INC.
K772422 12/28/1977 QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA BIO-RAD
K772221 12/05/1977 LENS, HARD RESIN BORANI INTL.
K772296 12/13/1977 INSPIRON MANIFOLD C.R. BARD, INC.
K772294 12/13/1977 INSPIRON MANIFOLD (DOUBLE) C.R. BARD, INC.
K772295 12/13/1977 INSPIRON MANIFOLD (SINGLE) C.R. BARD, INC.
K772338 12/22/1977 SYRINGE, BLOOD, SAMPLING, ARTERIAL C.R. BARD, INC.
K772235 12/07/1977 HAND CONTROL ACCESS.-ELECTROSURG. UNITS CAMERON-MILLER, INC.
K772241 12/08/1977 PULSE GENERATOR, BIPOLAR, DEMAND CARDIAC PACEMAKERS, INC.
K772239 12/08/1977 PULSE GENERATOR, BIPOLAR, PROGRAMMABLE CARDIAC PACEMAKERS, INC.
K772240 12/08/1977 PULSE GENERATOR, UNIPOLAR, DEMAND CARDIAC PACEMAKERS, INC.
K772238 12/08/1977 PULSE GENERATOR, UNIPOLAR, PROGRAMABLE CARDIAC PACEMAKERS, INC.
K772351 12/22/1977 DENTAL LIGHT CHEMETRON DENTAL PRODUCTS
K772284 12/12/1977 BUBBLE-TYPE OXYGENATOR COBE LABORATORIES, INC.
K772218 12/02/1977 CATHETER, SILICONE COATED CONCORD LABORATORIES, INC.
K772309 12/09/1977 ENDOCARDIAL PACING ELECTRODE CORATOMIC, INC.
K772355 12/27/1977 BLOOD LINE COMP. NEG. PRESS. PILLOW CORDIS CORP.
K772225 12/06/1977 PATELLAR PROSTHESIS CUTTER LABORATORIES, INC.
K772292 12/12/1977 T-TUBE WHELAN-MOSS DAVOL, INC.
K772315 12/19/1977 KWIKAP DEN-MAT CORP.
K772316 12/19/1977 MATRIX STRIP, DEAD-SOFT DEN-MAT CORP.
K772314 12/19/1977 WEDGES, RETAINING, MATRIX DEN-MAT CORP.
K772368 12/27/1977 SPECTACLE FRAME, OP-TITE DENTSPLY INTL.
K772359 12/27/1977 PREGNANCY TEST KIT, ANSWER DIAGNOSTIC TESTING, INC.
K772322 12/19/1977 DEPILATORY, ELECTRONIC DURA CORP., THE
K772285 12/13/1977 ACA LIPASE VERIFIERS E.I. DUPONT DE NEMOURS & CO., INC.
K772396 12/27/1977 ALLIGATOR CUP FORCEPS EDWARD WECK, INC.
K772392 12/27/1977 ALLPORT MASTOID RETRACTORS EDWARD WECK, INC.
K772373 12/27/1977 ANDERSON-NEIVERT OSTEOTOME EDWARD WECK, INC.
K772370 12/27/1977 BARRAQUER OVAL SPECULUM-VARIOUS SIZES EDWARD WECK, INC.
K772371 12/27/1977 BAYONET SURGICAL INSTRUMENTS EDWARD WECK, INC.
K772391 12/27/1977 BOIES NASAL FRACTURE ELEVATOR EDWARD WECK, INC.
K772393 12/27/1977 CARROLL TENDON RETRIEVER EDWARD WECK, INC.
K772388 12/27/1977 CONVERSE-GILLIES NEEDLE HOLDER EDWARD WECK, INC.
K772397 12/27/1977 COTTLE COLUMELLA FORCEP EDWARD WECK, INC.
K772398 12/27/1977 COTTLE LOWER LATERAL FORCEPS EDWARD WECK, INC.
K772389 12/27/1977 DANDY HEMOSTATIC FORCEPS EDWARD WECK, INC.
K772395 12/27/1977 DAVIS RHYTIDECTOMY EDWARD WECK, INC.
K772390 12/27/1977 DAY EAR HOOK EDWARD WECK, INC.
K772399 12/27/1977 DINGMAN ZYGOMA ELEVATOR EDWARD WECK, INC.
K772380 12/27/1977 FARRIOR OVAL SPECULUM EDWARD WECK, INC.
K772377 12/27/1977 HILDYARD POST NASAL FORCEP EDWARD WECK, INC.
K772379 12/27/1977 JOSEPH SAW EDWARD WECK, INC.
K772394 12/27/1977 KALRN FACE-LIFE SCISSORS EDWARD WECK, INC.
K772387 12/27/1977 LEAD HAND EDWARD WECK, INC.
K772383 12/27/1977 LONG JEWELERS FORCEPS EDWARD WECK, INC.
K772384 12/27/1977 MYRINGOTOMY KNIFE EDWARD WECK, INC.
K772376 12/27/1977 NEIVERT OSTEOTOME EDWARD WECK, INC.
K772378 12/27/1977 NEIVS TRACHEOTOMY RETRACTOR EDWARD WECK, INC.
K772381 12/27/1977 RING HANDLE & RETRACTORS EDWARD WECK, INC.
K772372 12/27/1977 ROLLER KNIFE EDWARD WECK, INC.
K772374 12/27/1977 SILVER OSTEOTOME EDWARD WECK, INC.
K772385 12/27/1977 THIN-BLADED NASAL SPECULUM EDWARD WECK, INC.
K772337 12/22/1977 URINARY 17-KETOSTERIOD/17 EPPENDORF-BRINKMANN, INC.
K772424 12/28/1977 RYUSEI ERCONA CORP.
K772307 12/16/1977 PCO 2 ELECTROLYTE FISHER SCIENTIFIC CO., LLC.
K772406 12/27/1977 AESTHESIOMETER FRED SAMMONS, INC.
K772403 12/27/1977 CUT-DOWN BUILT-UP TOILET SEAT FRED SAMMONS, INC.
K772415 12/27/1977 DYNAMETER 50 LB. FRED SAMMONS, INC.
K772404 12/27/1977 FINGER EXERCISE BOARD FRED SAMMONS, INC.
K772419 12/27/1977 HEEL OR ELBOW PROTECTOR FRED SAMMONS, INC.
K772401 12/27/1977 LAP BOARD W/RIM FRED SAMMONS, INC.
K772413 12/27/1977 PINCH GUAGE FRED SAMMONS, INC.
K772411 12/27/1977 PLATFORM SPLINTS FRED SAMMONS, INC.
K772416 12/27/1977 PRE-FORMED SPLINT BLANKS FRED SAMMONS, INC.
K772402 12/27/1977 QUADRIPLEGIC URINARY DRAINAGE VALVE FRED SAMMONS, INC.
K772420 12/27/1977 REAR FASTENING SAFETY STRAP FRED SAMMONS, INC.
K772410 12/27/1977 RESTING PAN SPLINTS FRED SAMMONS, INC.
K772414 12/27/1977 SANDBAGS, VARIOUS WEIGHTS FRED SAMMONS, INC.
K772417 12/27/1977 SLIDING BOARD FRED SAMMONS, INC.
K772405 12/27/1977 TUBING CLAMP FRED SAMMONS, INC.
K772421 12/27/1977 WHEELCHAIR BELT FRED SAMMONS, INC.
K772361 12/27/1977 LASER IMMUNONEPHELOMETRIC ANALYZER G.D. SEARLE AND CO.
K772325 12/19/1977 DENSITOMETER 18, COMPUTING, AUTO. GELMAN INSTRUMENT CO.
K772304 12/15/1977 DENTAL IMPLANT, CARBON COATED METAL GENERAL ATOMIC CO.
K772360 12/27/1977 ARRHYTHMIA MODULE GENERAL ELECTRIC CO.
K772317 12/19/1977 CT/T SYSTEM MODEL B7800A GENERAL ELECTRIC CO.
K772283 12/12/1977 RX PEDESTAL TABLE GENERAL ELECTRIC CO.
K772288 12/12/1977 CATHETER, CHOLANGIOGRAM, OPERATIVE GESCO INTL., INC.
K772319 12/19/1977 ANALYZER, CLINICAL, SYSTEM 3 GILFORD INSTRUMENT LABORATORIES, INC.
K772344 12/27/1977 DATA ACQUISITION & COLLATING SYS. GILFORD INSTRUMENT LABORATORIES, INC.
K772243 12/08/1977 TOXO TEST GULL LABORATORIES, INC.
K772258 12/09/1977 CLINICARD CK-II HARLECO
K772286 12/12/1977 FORCEPS, SUTURE, AUTO HARTMANN GROUP, INC.
K772346 12/23/1977 PHONIC MIRROR HANDIVOCIE MODEL 110 HC ELECTRONICS
K772347 12/23/1977 PHONIC MIRROR HANDIVOICE MODEL 120 HC ELECTRONICS
K772364 12/27/1977 AUTO. SAMPLING SYSTEM HEWLETT-PACKARD CO.
K772234 12/07/1977 CARDIAC OUTPUT MODULE-78231C HEWLETT-PACKARD CO.
K772367 12/27/1977 CHEST BELLOWS, SMALL HONEYWELL, INC.
K772216 12/02/1977 PORT-A-BOUT 240 HUDSON OXYGEN THERAPY SALES CO.
K772217 12/02/1977 TEMPERATURE MONITOR HUDSON OXYGEN THERAPY SALES CO.
K772426 12/27/1977 17-HYDROXY TEST HYCEL, INC.
K772328 12/21/1977 LAS-R HUMAN ANTITHROMBIN III TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K772327 12/21/1977 LAS-R HUMAN IGD TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K772329 12/21/1977 LAS-R HUMAN PREALBUMIN TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K772219 12/05/1977 FIAX TEST FOR ANTI-RUBELLA ANTIBODY IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS
K772233 12/07/1977 THERMOMETER RECAL ADAPTER INFO-CHEM
K772226 12/06/1977 PACEMAKER, MODEL 225 & 227 INTERMEDICS, INC.
K772350 12/23/1977 PATIENT ALERT MODEL 555 INTERMEDICS, INC.
K772353 12/23/1977 EKG ACQUISITION & ANALYSIS CART INTL. BUSINESS MACHINES
K772230 12/06/1977 CANNULA, PERFUSION, FALLOPIAN TUBE J. SKLAR MFG. CO., INC.
K772229 12/06/1977 MINICLAMPS, STABILIZ., FALLOPIAN TUBE J. SKLAR MFG. CO., INC.
K772308 12/16/1977 AUTOZYME GLUCOSE OXIDASE (TRINDER) J.T. BAKER CHEMICAL CO.
K772336 12/19/1977 GLOVE & LATEX FINGER COTS JAMAR HEALTH PRODUCTS
K772256 12/09/1977 CROWN & BRIDGE ALLOY JOHNSON & JOHNSON PROFESSIONALS, INC.
K772278 12/12/1977 FOTOFILL ACTIVATOR LIGHT JOHNSON & JOHNSON PROFESSIONALS, INC.
K772279 12/12/1977 FOTOFILL DENTAL RESTORATIVE JOHNSON & JOHNSON PROFESSIONALS, INC.
K772248 12/09/1977 ALBUMIN NEPHELOMETRIC ASSAY KALLESTAD LABORATORIES, INC.
K772250 12/09/1977 ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY KALLESTAD LABORATORIES, INC.
K772246 12/09/1977 ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY KALLESTAD LABORATORIES, INC.
K772255 12/09/1977 CERULOPLASMIN NEPHEL. ASSAY KALLESTAD LABORATORIES, INC.
K772249 12/09/1977 COMPLEMENT C3 NEPHELOMETRIC ASSAY KALLESTAD LABORATORIES, INC.
K772247 12/09/1977 COMPLEMENT C4 NEPHELOMETRIC ASSAY KALLESTAD LABORATORIES, INC.
K772345 12/23/1977 FLUORESCEIN CONJUG. FRACT. MONO. ANTI. KALLESTAD LABORATORIES, INC.
K772245 12/09/1977 HAPTOGLOBIN NEPHELOMETRIC ASSAY KALLESTAD LABORATORIES, INC.
K772251 12/09/1977 IMMUNOGLOBULIN A NEPHEL. ASSAY KALLESTAD LABORATORIES, INC.
K772252 12/09/1977 IMMUNOGLOBULIN G NEPHEL. ASSAY KALLESTAD LABORATORIES, INC.
K772254 12/09/1977 IMMUNOGLOBULIN M NEPHEL. ASSAY KALLESTAD LABORATORIES, INC.
K772253 12/09/1977 TRANSFERRIN NEPHELOMETRIC ASSAY KALLESTAD LABORATORIES, INC.
K772297 12/13/1977 INSUFFLATOR, MODEL G100 & 200 KLI
K772242 12/08/1977 LAPAROSCOPY CONSOLE MODEL VIII KLI
K772220 12/05/1977 PROBE, COAGULATION ACCESSORY KLI
K772211 12/01/1977 TEMP. ACRYLIC LACTONG CORP.
K772341 12/22/1977 BLADDER KIT - 734000 LATEX IND., INC.
K772277 12/09/1977 BLADDER RETENTION-CATHETHERIZATIONTRAY LATEX IND., INC.
K772340 12/22/1977 CATHETERIZATION KIT 732016-732018 LATEX IND., INC.
K772342 12/22/1977 ROBINSON KIT - 750014 & 750016 LATEX IND., INC.
K772244 12/09/1977 ILLUMINATED DENTAL HANDPIECE LITTON DENTAL PRODUCTS
K772282 12/12/1977 HODGE TUBE MALLINCKRODT CRITICAL CARE
K772268 12/09/1977 DEMI-WALKER (REGULAR) MEDFUSION SYSTEMS, INC.
K772266 12/09/1977 INSTRUMENT TRAY MEDFUSION SYSTEMS, INC.
K772267 12/09/1977 QUADRAPLEGIC WALKING AID MEDFUSION SYSTEMS, INC.
K772276 12/09/1977 RAISED TOILET SEAT MEDFUSION SYSTEMS, INC.
K772269 12/09/1977 SETUP WALKER ADJUSTABLE MEDFUSION SYSTEMS, INC.
K772270 12/09/1977 SETUP WALKER OVER TOILET CONSTRUC. MEDFUSION SYSTEMS, INC.
K772260 12/09/1977 TELESCOPING BEDRAILS MEDFUSION SYSTEMS, INC.
K772275 12/09/1977 TOILET SAFETY RAIL MEDFUSION SYSTEMS, INC.
K772262 12/09/1977 TRAPEZE BAR KNOCKED DOWN MEDFUSION SYSTEMS, INC.
K772261 12/09/1977 TRAPEZE FLOOR BASE MEDFUSION SYSTEMS, INC.
K772271 12/09/1977 WALKER FOLDING ADJUSTABLE MEDFUSION SYSTEMS, INC.
K772365 12/27/1977 THERMOMETER SHEATHS MEDLINE INDUSTRIES, INC.
K780001 12/30/1977 EPIDURAL LEAD - MODEL 3481 MEDTRONIC VASCULAR
K772357 12/27/1977 PULSE GENERATORS MEDTRONIC VASCULAR
K772236 12/07/1977 FILTER, PERITONEAL DIALY. ADMIN. SET MILLIPORE CORP.
K772321 12/19/1977 ARTHROSTRESS MTD, INC.
K772354 12/27/1977 I.V. CATHETER NDM CORP.
K772323 12/19/1977 RIANEN ESTRIOL RIA KIT NEW ENGLAND NUCLEAR
K772425 12/29/1977 RIANEN GENTAMICIN RIA KIT NEW ENGLAND NUCLEAR
K772305 12/14/1977 RAD. THERAPY PLANNING SUP. SYS. OHIO NUCLEAR, INC.
K780002 12/30/1977 ANTITHROMBIN III ASSAY ORTHO DIAGNOSTICS, INC.
K772289 12/12/1977 SCANNER, CT, 0400 PFIZER MEDICAL SYSTEMS, INC.
K772291 12/12/1977 DIAG. CONSOLE, INDEPENDENT PFIZER, INC.
K772320 12/19/1977 EMERGENCY CART PHYSIO-CONTROL CORP.
K772209 12/01/1977 CULTURE COLLEC. TRANS. SYS., DOUBLE DRY PRECISION DYNAMICS CORP.
K772205 12/01/1977 CULTURE COLLEC. TRANS. SYS., DOUBLE WET PRECISION DYNAMICS CORP.
K772210 12/01/1977 CULTURE COLLEC. TRANS. SYS., DOUBLE WET PRECISION DYNAMICS CORP.
K772208 12/01/1977 CULTURE COLLEC. TRANS. SYS., SINGLE DRY PRECISION DYNAMICS CORP.
K772206 12/01/1977 CULTURE COLLEC. TRANS. SYS., SINGLE WET PRECISION DYNAMICS CORP.
K772207 12/01/1977 CULTURE COLLEC. TRANS. SYS., SINGLE WET PRECISION DYNAMICS CORP.
K772301 12/14/1977 LAPAROSCOPY DRAPE, BOUNDARY PROCTER & GAMBLE MFG. CO.
K772293 12/12/1977 BONE MARROW BIOPSY DEVICE RADIATION DEVELOPMENT CO., INC.
K772281 12/12/1977 RSL INSULIN KIT RADIOASSAY SYSTEMS LABORATORIES, INC.
K772290 12/12/1977 DIALYZER, CAPILATORY, HOLLOW FIBER REDY LABORATORIES
K772348 12/23/1977 NEBULIZER ADAPTER RESPIRATORY CARE, INC.
K772287 12/12/1977 MUSCLE STIMULATOR RICH-MAR CORP.
K772313 12/12/1977 X-RAY CO-ORDINATOR RINN CORP.
K772300 12/14/1977 DENTAL CHAIR, VANGUARD RITTER CO.
K780003 12/29/1977 ENDOSOLV E SEPTODONT, INC.
K772237 12/08/1977 OXYGENATOR, BUBBLE SHILEY, INC.
K772298 12/13/1977 SEXUAL ASSAULT FORENCIC EVIDENCE KIT SIMPSON/BASYE, INC.
K772280 12/09/1977 RECEPTAL ATS MEDIASTINAL LINER SORENSEN RESEARCH
K772257 12/05/1977 ALKALINE PHOSPHATASE TEST SET STANBIO LABORATORY
K772224 12/05/1977 NERVE STIMULATOR, ELEC. TRANSCUTANEOUS STIMULATION TECHNOLOGY, INC.
K772352 12/23/1977 STAC SYSTEM - ADDITIONAL ANALYTES TECHNICON INSTRUMENTS CORP.
K772332 12/22/1977 MONITOR, CARDIAC, BEDSIDE TELECTRONICS, INC.
K772334 12/22/1977 MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP TELECTRONICS, INC.
K772333 12/22/1977 RECORDER, PAPER, ECG TELECTRONICS, INC.
K772331 12/22/1977 RESTERIL. OF IMPLANT. ELECT. & ADAPTER TELECTRONICS, INC.
K772362 12/27/1977 AVF SET FOR SINGLE NEEDLE HEMODIALYSIS TERUMO AMERICA, INC.
K772318 12/19/1977 DIALYZER STANDARD, CODE 5DM1780 TRAVENOL LABORATORIES, S.A.
K772222 12/05/1977 NEBULIZER SET-2C7105 TRAVENOL LABORATORIES, S.A.
K772299 12/13/1977 TRANSPARENT MANIFOLD UNI-RESEARCH
K772213 12/02/1977 LAMP DELIVERY SYS.-PHOTOCOAGULATION VARIAN ASSOC., INC.
K772214 12/02/1977 OPHTHALMOSCOPE, BINOCULAR, INDIRECT VARIAN ASSOC., INC.
K772311 12/19/1977 WISP MODEL 710 WATERS ASSOC., INC.
K772306 12/15/1977 125I DIGOXIN TEST SET WIEN LABORATORIES, INC.
K772356 12/27/1977 LDH ISOENZYME COLUMN REAGENT SET WORTHINGTON BIOCHEMICAL CORP.


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