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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 K131050
Device Name NXSTAGE 1.6M2 DIALYZER
Applicant
NXSTAGE MEDICAL, INC.
350 Merrimack St
LAWRENCE,  MA  01843
Applicant Contact NNAMDI NWACHUKWU
Correspondent
NXSTAGE MEDICAL, INC.
350 Merrimack St
LAWRENCE,  MA  01843
Correspondent Contact NNAMDI NWACHUKWU
Regulation Number876.5860
Classification Product Code
KDI  
Date Received04/15/2013
Decision Date 12/27/2013
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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