FDA 510(k) Application Details - K023615

Device Classification Name	Hemodialyzer, Re-Use, High Flux   More FDA Info for this Device
510(K) Number	K023615
Device Name	Hemodialyzer, Re-Use, High Flux
Applicant	GAMBRO RENAL PRODUCTS 10810 W. COLLINS AVE. LAKEWOOD, CO 80215 US Other 510(k) Applications for this Company
Contact	JEFFREY R SHIDEMAN Other 510(k) Applications for this Contact
Regulation Number	876.5860   More FDA Info for this Regulation Number
Classification Product Code	MSF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2002
Decision Date	05/06/2003
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