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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 K111174
Device Name NXSTAGE PUREFLOW SL
Applicant
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST., 5TH FLOOR
LAWRENCE,  MA  01843
Applicant Contact MARY LOU STROUMBOS
Correspondent
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST., 5TH FLOOR
LAWRENCE,  MA  01843
Correspondent Contact MARY LOU STROUMBOS
Regulation Number876.5820
Classification Product Code
FKR  
Date Received04/27/2011
Decision Date 09/19/2011
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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