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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K143082
Device Name IV Administration Sets with 200(micro)m Blood Filter
Applicant
B. Braun Medical Inc.
901 Marcon Blvd
Allentown,  PA  18109
Applicant Contact Angela J Caravella
Correspondent
B. Braun Medical Inc.
901 Marcon Blvd
Allentown,  PA  18109
Correspondent Contact Angela J Caravella
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/27/2014
Decision Date 07/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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