FDA 510(k) Application Details - K202508

Device Classification Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)   More FDA Info for this Device
510(K) Number	K202508
Device Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant	Di-Chem, Inc. 12297 Ensigh Avenue North Champlin, MN 55316 US Other 510(k) Applications for this Company
Contact	Keith Buchholz 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	08/31/2020
Decision Date	08/12/2022
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