FDA 510(k) Application Details - K191093

Device Classification Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)   More FDA Info for this Device
510(K) Number	K191093
Device Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant	Isopure, Corp. 11851 Plantside Drive Louisville, KY 40299 US Other 510(k) Applications for this Company
Contact	Kevin Gillespie 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	04/25/2019
Decision Date	01/22/2020
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