FDA 510(k) Application Details - K153084

Device Classification Name	System, Water Purification, General Medical Use   More FDA Info for this Device
510(K) Number	K153084
Device Name	System, Water Purification, General Medical Use
Applicant	NEPHROS INC. 41 GRAND AVE River Edge, NJ 07661 US Other 510(k) Applications for this Company
Contact	JAMES SUMMERTON Other 510(k) Applications for this Contact
Regulation Number	876.5665   More FDA Info for this Regulation Number
Classification Product Code	NHV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/26/2015
Decision Date	04/08/2016
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