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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 K143313
Device Name NxStage Therapeutic Plasma Exchange (TPE) Cartridge
Applicant
NxStage Medical, Inc.
350 Merrimack Street
Lawrence,  MA  01843
Applicant Contact Randall J Covill
Correspondent
NxStage Medical, Inc.
350 Merrimack Street
Lawrence,  MA  01843
Correspondent Contact Randall J Covill
Regulation Number876.5860
Classification Product Code
KDI  
Subsequent Product Code
LKN  
Date Received11/19/2014
Decision Date 03/20/2015
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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