FDA 510(k) Application Details - K010805

Device Classification Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System   More FDA Info for this Device
510(K) Number	K010805
Device Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant	GAMBRO RENAL PRODUCTS 10810 W. COLLINS AVE. LAKEWOOD, CO 80215 US Other 510(k) Applications for this Company
Contact	SUZANNE DENNIS Other 510(k) Applications for this Contact
Regulation Number	876.5860   More FDA Info for this Regulation Number
Classification Product Code	KDI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2001
Decision Date	08/06/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review