FDA 510(k) Application Details - K113634

Device Classification Name	Endoscopic Injection Needle, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K113634
Device Name	Endoscopic Injection Needle, Gastroenterology-Urology
Applicant	COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK LIMERICK EL IE Other 510(k) Applications for this Company
Contact	LAURA GUINANE Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2011
Decision Date	02/14/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review