FDA 510(k) Application Details - K080964

Device Classification Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System   More FDA Info for this Device
510(K) Number	K080964
Device Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant	FRESENIUS MEDICAL CARE NORTH AMERICA 920 Winter Street Waltham, MA 02451-1457 US Other 510(k) Applications for this Company
Contact	JANET C KAY 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	04/04/2008
Decision Date	01/14/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review