FDA 510(k) Application Details - K124035

Device Classification Name	Hemodialysis System For Home Use   More FDA Info for this Device
510(K) Number	K124035
Device Name	Hemodialysis System For Home Use
Applicant	FRESENIUS MEDICAL CARE NORTH AMERICA 920 Winter Street Waltham, MA 02451-1457 US Other 510(k) Applications for this Company
Contact	DENISE OPPERMANN Other 510(k) Applications for this Contact
Regulation Number	876.5860   More FDA Info for this Regulation Number
Classification Product Code	ONW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/28/2012
Decision Date	07/03/2013
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