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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dialyzer, high permeability with or without sealed dialysate system
510(k) Number K122051
Device Name NXSTAGE SYSTEM ONE
Applicant
NXSTAGE MEDICAL, INC.
350 Merrimack St
LAWRENCE,  MA  01843
Applicant Contact MARY LUO STROUMBOS
Correspondent
NXSTAGE MEDICAL, INC.
350 Merrimack St
LAWRENCE,  MA  01843
Correspondent Contact MARY LUO STROUMBOS
Regulation Number876.5860
Classification Product Code
KDI  
Date Received07/12/2012
Decision Date 04/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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