FDA 510(k) Application Details - K043461

Device Classification Name	Set, Perfusion, Kidney, Disposable   More FDA Info for this Device
510(K) Number	K043461
Device Name	Set, Perfusion, Kidney, Disposable
Applicant	DR. FRANZ KOHLER CHEMIE GMBH 2305 GOLD MINE RD. BROOKEVILLE, MD 20833 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	KDL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2004
Decision Date	02/28/2005
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