FDA 510(k) Application Details - K130103

Device Classification Name System, Image Processing, Radiological

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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
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Regulation Number 892.2050

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Classification Product Code LLZ
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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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