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FDA 510(k) Application Details - K191910
Device Classification Name
Accessories, Pump, Infusion
More FDA Info for this Device
510(K) Number
K191910
Device Name
Accessories, Pump, Infusion
Applicant
B. Braun Melsugen AG
Carl-Braun-Strasse 1
Melsungen 34212 DE
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Contact
Ullrich Trottier
Other 510(k) Applications for this Contact
Regulation Number
880.5725
More FDA Info for this Regulation Number
Classification Product Code
MRZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/17/2019
Decision Date
03/12/2020
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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