FDA 510(k) Application Details - K013575

Device Classification Name	System, Perfusion, Kidney   More FDA Info for this Device
510(K) Number	K013575
Device Name	System, Perfusion, Kidney
Applicant	ORGAN RECOVERY SYSTEMS, INC. 701 EAST BAY ST. SUITE 433 CHARLESTON, SC 29403 US Other 510(k) Applications for this Company
Contact	STANLEY J HARRIS Other 510(k) Applications for this Contact
Regulation Number	876.5880   More FDA Info for this Regulation Number
Classification Product Code	KDN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/29/2001
Decision Date	01/25/2002
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