FDA 510(k) Application Details - K123395

Device Classification Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System   More FDA Info for this Device
510(K) Number	K123395
Device Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant	NXSTAGE MEDICAL, INC. 350 Merrimack St LAWRENCE, MA 01843 US Other 510(k) Applications for this Company
Contact	MARY LOU STROUMBOS 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	11/05/2012
Decision Date	03/07/2013
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