FDA 510(k) Application Details - K102194

Device Classification Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)   More FDA Info for this Device
510(K) Number	K102194
Device Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant	B. BRAUN AVITUM AG 901 MARCON BLVD. ALLENTOWN, PA 18109 US Other 510(k) Applications for this Company
Contact	ANGELA CARAVELLA 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	08/04/2010
Decision Date	04/25/2011
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