FDA 510(k) Application Details - K192017

Device Classification Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)   More FDA Info for this Device
510(K) Number	K192017
Device Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant	Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451 US Other 510(k) Applications for this Company
Contact	Denise Oppermann 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	07/29/2019
Decision Date	04/24/2020
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