FDA 510(k) Application Details - K131611

Device Classification Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)   More FDA Info for this Device
510(K) Number	K131611
Device Name	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant	FRESENIUS MEDICAL CARE NORTH AMERICA 920 WINTER ST 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	06/03/2013
Decision Date	08/29/2013
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