FDA 510(k) Application Details - K121430

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K121430
Device Name	Catheter, Biliary, Diagnostic
Applicant	COOK IRELAND LTD O HALLORAN ROAD NATIONAL TECHNOLOGY PARK LIMERICK 000 IE Other 510(k) Applications for this Company
Contact	Jacinta Kilmartin 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	05/14/2012
Decision Date	03/01/2013
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