FDA 510(k) Application Details - K010760

Device Classification Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)   More FDA Info for this Device
510(K) Number	K010760
Device Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant	ADVANCED RENAL TECHNOLOGIES, INC. 11838 N.E. 112TH ST. KIRKLAND, WA 98033 US Other 510(k) Applications for this Company
Contact	ROBIN CALLAN 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	03/13/2001
Decision Date	06/11/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review