FDA 510(k) Application Details - K014215

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K014215
Device Name	Catheter, Biliary, Diagnostic
Applicant	W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. FLAGSTAFF,, AZ 86002 US Other 510(k) Applications for this Company
Contact	JACQUELINE KALBACH 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	12/21/2001
Decision Date	12/19/2002
Decision	SESU - SE - WITH LIMITATIONS
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