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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 K012510
Device Name MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM
Applicant
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST.
SUITE 501
S. LAWRENCE,  MA  01843
Applicant Contact KAREN ST.ONGE
Correspondent
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST.
SUITE 501
S. LAWRENCE,  MA  01843
Correspondent Contact KAREN ST.ONGE
Regulation Number876.5860
Classification Product Code
KDI  
Date Received08/06/2001
Decision Date 10/19/2001
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
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