FDA 510(k) Application Details - K081043

Device Classification Name	Accessories, Blood Circuit, Hemodialysis   More FDA Info for this Device
510(K) Number	K081043
Device Name	Accessories, Blood Circuit, Hemodialysis
Applicant	NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR LAWRENCE, MA 01843 US Other 510(k) Applications for this Company
Contact	MARY LOU STROUMBOS 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	04/14/2008
Decision Date	07/07/2008
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