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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ultrafiltration-controlled nocturnal dialysate delivery system
510(k) Number K141752
FOIA Releasable 510(k) K141752
Device Name NXSTAGE SYSTEM ONE
Applicant
NXSTAGE MEDICAL, INC.
350 MERRIMACK STREET
LAWRENCE,  MA  01843
Applicant Contact MARY LOU STROUMBOS
Correspondent
NXSTAGE MEDICAL, INC.
350 MERRIMACK STREET
LAWRENCE,  MA  01843
Correspondent Contact MARY LOU STROUMBOS
Regulation Number876.5860
Classification Product Code
ODN  
Date Received06/30/2014
Decision Date 12/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT00667511
Reviewed by Third Party No
Combination Product No
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