FDA 510(k) Application Details - K970648

Device Classification Name	Hemodialyzer, Re-Use, High Flux   More FDA Info for this Device
510(K) Number	K970648
Device Name	Hemodialyzer, Re-Use, High Flux
Applicant	RENAL SYSTEMS, INC. 14605 28TH AVENUE NORTH MINNEAPOLIS, MN 55447 US Other 510(k) Applications for this Company
Contact	LYNN M LUEDERS 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	02/20/1997
Decision Date	01/05/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review