FDA 510(k) Application Details - K152953

Device Classification Name	Accessories, Blood Circuit, Hemodialysis   More FDA Info for this Device
510(K) Number	K152953
Device Name	Accessories, Blood Circuit, Hemodialysis
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	876.5820   More FDA Info for this Regulation Number
Classification Product Code	KOC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/2015
Decision Date	11/05/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review