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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 K113023
Model BTS-001
Device Name STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER
Original Applicant
NXSTAGE MEDICAL, INC.
439 south union st., 5th floor
lawrence,  MA  01843
Original Contact mary lou stroumbos
Regulation Number876.5860
Classification Product Code
KDI  
Subsequent Product Codes
FJK   KOC  
Date Received10/11/2011
Decision Date 12/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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