FDA 510(k) Application Details - K083158

Device Classification Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System   More FDA Info for this Device
510(K) Number	K083158
Device Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant	GAMBRO, INC. 14143 DENVER WEST PARKWAY LAKEWOOD, CO 80401 US Other 510(k) Applications for this Company
Contact	KAE MILLER 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	10/24/2008
Decision Date	06/05/2009
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