FDA 510(k) Application Details - K042969

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K042969
Device Name	Catheter, Biliary, Diagnostic
Applicant	CORDIS CORP. 7 POWDER HORN DR. WARREN, NJ 07059 US Other 510(k) Applications for this Company
Contact	DONNA MARSHALL 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	10/28/2004
Decision Date	11/08/2004
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review