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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 K080919
Device Name NXSTAGE PUREFLOW SL
Applicant
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST., 5TH FLOOR
LAWRENCE,  MA  01843
Applicant Contact MICHAEL DOYLE
Correspondent
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST., 5TH FLOOR
LAWRENCE,  MA  01843
Correspondent Contact MICHAEL DOYLE
Regulation Number876.5820
Classification Product Code
FKR  
Date Received04/01/2008
Decision Date 10/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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