FDA 510(k) Application Details - K181991

Device Classification Name	System, Dialysate Delivery, Single Patient   More FDA Info for this Device
510(K) Number	K181991
Device Name	System, Dialysate Delivery, Single Patient
Applicant	NxStage Medical, Inc 350 Merrimack Street Lawrence, MA 01843 US Other 510(k) Applications for this Company
Contact	Christina Marabella Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FKP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2018
Decision Date	09/26/2018
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