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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 K050727
Device Name MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS
Applicant
Nxstage Medical, Inc.
439 S. Union St. Suite 501
Lawrence,  MA  01843
Applicant Contact NORMA LEMAY
Correspondent
Nxstage Medical, Inc.
439 S. Union St. Suite 501
Lawrence,  MA  01843
Correspondent Contact NORMA LEMAY
Regulation Number876.5860
Classification Product Code
KDI  
Date Received03/21/2005
Decision Date 06/13/2005
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
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