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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 K032356
Device Name NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS
Applicant
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST.
SUITE 501
LAWRENCE,  MA  01843
Applicant Contact NORMA LEMAY
Correspondent
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST.
SUITE 501
LAWRENCE,  MA  01843
Correspondent Contact NORMA LEMAY
Regulation Number876.5860
Classification Product Code
KDI  
Date Received07/30/2003
Decision Date 10/28/2003
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 No
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