FDA 510(k) Application Details - K160847

Device Classification Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)   More FDA Info for this Device
510(K) Number	K160847
Device Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant	ROCKWELL MEDICAL 30142 WIXOM ROAD WIXOM, MI 48393 US Other 510(k) Applications for this Company
Contact	ROBERT CHIOINI Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	KPO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2016
Decision Date	10/20/2016
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