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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 K170469
Device Name NxStage System One Plus
Applicant
NxStage Medical, Inc
350 Merrimack Street
Lawrence,  MA  01843
Applicant Contact Randall Covill
Correspondent
NxStage Medical, Inc
350 Merrimack Street
Lawrence,  MA  01843
Correspondent Contact Randall Covill
Regulation Number876.5860
Classification Product Code
KDI  
Date Received02/16/2017
Decision Date 05/09/2017
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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