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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K201469
Device Name Mini Spike Plus 6/8R
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
LHI  
Date Received06/03/2020
Decision Date 12/09/2020
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
Predetermined Change
Control Plan Authorized		 No
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