FDA 510(k) Application Details - K972066

Device Classification Name	System, Perfusion, Kidney   More FDA Info for this Device
510(K) Number	K972066
Device Name	System, Perfusion, Kidney
Applicant	TRANS-MED CORP. 230 EVANS AVE. ELK RIVER, MN 55330 US Other 510(k) Applications for this Company
Contact	SAMUEL C MCGHEE 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	06/03/1997
Decision Date	11/26/1997
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