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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 K191658
Device Name IV Sets not made with PVC
Applicant
B. Braun Medical Inc.
901 Marcon Boulevard
Allentown,  PA  18109
Applicant Contact Angela J. Caravella
Correspondent
B. Braun Medical Inc.
901 Marcon Boulevard
Allentown,  PA  18109
Correspondent Contact Angela J. Caravella
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/21/2019
Decision Date 03/19/2020
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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