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FDA 510(k) Application Details - K161880
Device Classification Name
Display, Cathode-Ray Tube, Medical
More FDA Info for this Device
510(K) Number
K161880
Device Name
Display, Cathode-Ray Tube, Medical
Applicant
Barco N.V.
President Kennedypark 35
Kortrijk 8500 BE
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Contact
Lieven De Wandel
Other 510(k) Applications for this Contact
Regulation Number
870.2450
More FDA Info for this Regulation Number
Classification Product Code
DXJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/08/2016
Decision Date
03/14/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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