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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, temperature, dialysis
510(k) Number K140623
Device Name NXSTAGE EXPRESS FLUID WARMER
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 Number876.5820
Classification Product Code
FLA  
Date Received03/11/2014
Decision Date 06/16/2014
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
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