FDA 510(k) Application Details - K172922

Device Classification Name

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510(K) Number K172922
Device Name MMPC-4127F1
Applicant Barco N.V.
President Kennedypark 35
Kortrijk 8500 BE
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Contact Lieven De Wandel
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Regulation Number

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Classification Product Code PZZ
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Date Received 09/25/2017
Decision Date 12/21/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee PA - Pathology
Review Advisory Committee PA - Pathology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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