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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name subsystem, proportioning
510(k) Number K140571
Device Name NXSTAGE PUREFLOW SL
Applicant
NXSTAGE MEDICAL, INC.
350 MERRIMACK STREET
LAWRENCE,  MA  01843
Applicant Contact MARY L STROUMBOS
Correspondent
NXSTAGE MEDICAL, INC.
350 MERRIMACK STREET
LAWRENCE,  MA  01843
Correspondent Contact MARY L STROUMBOS
Regulation Number876.5820
Classification Product Code
FKR  
Date Received03/06/2014
Decision Date 05/15/2014
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
Recalls CDRH Recalls
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