FDA 510(k) Application Details - K002650

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K002650
Device Name	Catheter, Biliary, Diagnostic
Applicant	BENTEC MEDICAL, INC. 1380 EAST BEAMER ST. WOODLAND, CA 95776 US Other 510(k) Applications for this Company
Contact	DAVID TUCKER Other 510(k) Applications for this Contact
Regulation Number	876.5010   More FDA Info for this Regulation Number
Classification Product Code	FGE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2000
Decision Date	02/16/2001
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