FDA 510(k) Application Details - K180679

Device Classification Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)   More FDA Info for this Device
510(K) Number	K180679
Device Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant	Global Scientific Technologies, LLC 151 Old Jones Road Greer, SC 29651 US Other 510(k) Applications for this Company
Contact	William J. Griswold, Jr. 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	03/15/2018
Decision Date	12/07/2018
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