FDA 510(k) Application Details - K944436

Device Classification Name	Dialyzer, Capillary, Hollow Fiber   More FDA Info for this Device
510(K) Number	K944436
Device Name	Dialyzer, Capillary, Hollow Fiber
Applicant	COBE RENAL CARE, INC. 1185 OAK ST. LAKEWOOD, CO 80215-4407 US Other 510(k) Applications for this Company
Contact	JEFFREY R SHIDEMAN Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FJI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/1994
Decision Date	01/29/1996
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