FDA 510(k) Application Details - K090682

Device Classification Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System   More FDA Info for this Device
510(K) Number	K090682
Device Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant	EDWARDS LIFESCIENCES SERVICES GMBH BIOPARK BROADWATER ROAD WELWYN GARDEN CITY AL7 3AX GB Other 510(k) Applications for this Company
Contact	NEIL R ARMSTRONG 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	03/16/2009
Decision Date	11/19/2009
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