FDA 510(k) Application Details - K091656

Device Classification Name	Set, Perfusion, Kidney, Disposable   More FDA Info for this Device
510(K) Number	K091656
Device Name	Set, Perfusion, Kidney, Disposable
Applicant	ORGAN RECOVERY SYSTEMS, INC. 2570 EAST DEVON AVE DES PLAINES, IL 60018-4912 US Other 510(k) Applications for this Company
Contact	PJ PARDO Other 510(k) Applications for this Contact
Regulation Number	876.5880   More FDA Info for this Regulation Number
Classification Product Code	KDL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/09/2009
Decision Date	03/11/2010
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