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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 K213778
Device Name IV Administration Set
Applicant
B. Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109
Applicant Contact Tracy Larish
Correspondent
B. Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109
Correspondent Contact Tracy Larish
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/03/2021
Decision Date 03/03/2022
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
Predetermined Change
Control Plan Authorized		 No
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