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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 K093069
Device Name NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE
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 Number876.5860
Classification Product Code
KDI  
Date Received09/30/2009
Decision Date 10/23/2010
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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