FDA 510(k) Application Details - K994390

Device Classification Name	Hemodialyzer, Re-Use, High Flux   More FDA Info for this Device
510(K) Number	K994390
Device Name	Hemodialyzer, Re-Use, High Flux
Applicant	GAMBRO HEALTHCARE 1185 OAK ST. LAKEWOOD, CO 80215-4498 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	12/28/1999
Decision Date	10/26/2000
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