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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 K171331
Device Name NxStage System One
Applicant
NxStage Medical, Inc.
350 Merrimack Street
Lawrence,  MA  01843
Applicant Contact Paul Kravitz
Correspondent
NxStage Medical, Inc.
350 Merrimack Street
Lawrence,  MA  01843
Correspondent Contact Heather V. Nigro
Regulation Number876.5860
Classification Product Code
KDI  
Date Received05/08/2017
Decision Date 08/24/2017
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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