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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 K040696
Device Name MODIFICATION TO NXSTAGE SYSTEM ONE
Applicant
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST., 5TH FLOOR
LAWRENCE,  MA  01843
Applicant Contact NORMA LEMAY
Correspondent
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST., 5TH FLOOR
LAWRENCE,  MA  01843
Correspondent Contact NORMA LEMAY
Regulation Number876.5860
Classification Product Code
KDI  
Date Received03/17/2004
Decision Date 05/26/2004
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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