FDA 510(k) Application Details - K130792

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K130792
Device Name	Catheter, Biliary, Diagnostic
Applicant	C.R. BARD, INC. 1625 WEST 3RD ST. TEMPE, AZ 85281-1740 US Other 510(k) Applications for this Company
Contact	Christoph Wagner von Hoff 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	03/22/2013
Decision Date	08/30/2013
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