FDA 510(k) Application Details - K063742

Device Classification Name	Stent, Ureteral   More FDA Info for this Device
510(K) Number	K063742
Device Name	Stent, Ureteral
Applicant	COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK LIMERICK IE Other 510(k) Applications for this Company
Contact	SINEAD BURKE Other 510(k) Applications for this Contact
Regulation Number	876.4620   More FDA Info for this Regulation Number
Classification Product Code	FAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2006
Decision Date	05/08/2007
Decision	SESE - SUBST EQUIV
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