FDA 510(k) Application Details - K964688

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K964688
Device Name	Catheter, Biliary, Diagnostic
Applicant	CORDIS CORP. P.O. BOX 4917 35 & 40 TECHNOLOGY DRIVE WARREN, NJ 07059 US Other 510(k) Applications for this Company
Contact	JOAN MARTIN 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	11/22/1996
Decision Date	06/20/1997
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