FDA 510(k) Application Details - K970654

Device Classification Name	Hemodialyzer, Re-Use, Low Flux   More FDA Info for this Device
510(K) Number	K970654
Device Name	Hemodialyzer, Re-Use, Low Flux
Applicant	BAXTER HEALTHCARE CORP. 1620 WAULKEGAN RD. MCGAW PARK, IL 60085-6730 US Other 510(k) Applications for this Company
Contact	ROBERT L WILKINSON Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	MSE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/21/1997
Decision Date	11/12/1997
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