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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 K183158
Device Name NxStage Cartridge Express with Speedswap
Applicant
NxStage Medical, Inc.
350 Merrimack Street
Lawrence,  MA  01843
Applicant Contact Christina Marabella
Correspondent
NxStage Medical, Inc.
350 Merrimack Street
Lawrence,  MA  01843
Correspondent Contact Christina Marabella
Regulation Number876.5860
Classification Product Code
KDI  
Date Received11/15/2018
Decision Date 08/09/2019
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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