FDA 510(k) Application Details - K030099

Device Classification Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System   More FDA Info for this Device
510(K) Number	K030099
Device Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant	BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD., MPR-A2E 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	876.5860   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	01/10/2003
Decision Date	06/17/2003
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	Y
Expedited Review