FDA 510(k) Application Details - K030470

Device Classification Name	System, Dialysate Delivery, Sealed   More FDA Info for this Device
510(K) Number	K030470
Device Name	System, Dialysate Delivery, Sealed
Applicant	NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST. SUITE 501 LAWRENCE, MA 01843 US Other 510(k) Applications for this Company
Contact	NORMA LEMAY Other 510(k) Applications for this Contact
Regulation Number	876.5860   More FDA Info for this Regulation Number
Classification Product Code	FII Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2003
Decision Date	07/07/2003
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	Y
Expedited Review