FDA 510(k) Application Details - K183158

Device Classification Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System   More FDA Info for this Device
510(K) Number	K183158
Device Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant	NxStage Medical, Inc. 350 Merrimack Street Lawrence, MA 01843 US Other 510(k) Applications for this Company
Contact	Christina Marabella 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	11/15/2018
Decision Date	08/09/2019
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