FDA 510(k) Application Details - K960173

Device Classification Name	Bougie, Esophageal, And Gastrointestinal, Gastro-Urology   More FDA Info for this Device
510(K) Number	K960173
Device Name	Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
Applicant	GABRIEL MEDICAL, INC. ATTN: MARY M. MCNAMARA 49 PLAIN STREET NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	MARY MCNAMARA-CULLINANE Other 510(k) Applications for this Contact
Regulation Number	876.5365   More FDA Info for this Regulation Number
Classification Product Code	FAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/1996
Decision Date	06/27/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review