FDA 510(k) Applications for Medical Device Product Code "FAT"
(Bougie, Esophageal, And Gastrointestinal, Gastro-Urology)

FDA 510(k) Number Applicant Device Name Decision Date
K960173 GABRIEL MEDICAL, INC. INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT 06/27/1996
K972119 MEDOVATIONS, INC. MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) 02/02/1998
K983220 Stryker Endoscopy STRYKER INFRAVISION ESOPHAGEAL KIT 06/04/1999
K133439 Teleflex Medical, Inc. PILLING ESOPHAGEAL BOUGIES 06/16/2014


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