FDA 510(k) Application Details - K163609

Device Classification Name	System, Water Purification, General Medical Use   More FDA Info for this Device
510(K) Number	K163609
Device Name	System, Water Purification, General Medical Use
Applicant	PALL INTERNATIONAL SARL AVENUE DE TIVOLI 3 Fribourg CH-1700 CH Other 510(k) Applications for this Company
Contact	Karen Peterson-Doyle 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	12/22/2016
Decision Date	06/01/2017
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