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FDA 510(k) Application Details - K130103
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K130103
Device Name
System, Image Processing, Radiological
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
892.2050
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Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
01/15/2013
Decision Date
02/08/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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