FDA 510(k) Application Details - K955497

Device Classification Name	Set, Perfusion, Kidney, Disposable   More FDA Info for this Device
510(K) Number	K955497
Device Name	Set, Perfusion, Kidney, Disposable
Applicant	COBE RENAL CARE, INC. 4503 MOORLAND AVE. MINNEAPOLIS, MN 55424 US Other 510(k) Applications for this Company
Contact	JEFFREY R SHIDEMAN 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	12/01/1995
Decision Date	09/25/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review