FDA 510(k) Application Details - K992209

Device Classification Name	System, Perfusion, Kidney   More FDA Info for this Device
510(K) Number	K992209
Device Name	System, Perfusion, Kidney
Applicant	DR. FRANZ KOHLER CHEMIE GMBH 12300 TWINBROOK PKWY. SUITE 625 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	T. WHIT ATHEY 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	06/30/1999
Decision Date	12/10/1999
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