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FDA 510(k) Application Details - K201469
Device Classification Name
Set, I.V. Fluid Transfer
More FDA Info for this Device
510(K) Number
K201469
Device Name
Set, I.V. Fluid Transfer
Applicant
B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109 US
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Contact
Angela J. Caravella
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
LHI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/03/2020
Decision Date
12/09/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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