FDA 510(k) Application Details - K081184

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K081184
Device Name	Catheter, Biliary, Diagnostic
Applicant	W.L. GORE & ASSOCIATES INC, MEDICAL PRODUCTS DIV. 3250 WEST KILTIE LN. FLAGSTAFF, AZ 86002-0500 US Other 510(k) Applications for this Company
Contact	Michael Ivey 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	04/25/2008
Decision Date	07/22/2008
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