FDA 510(k) Application Details - DEN160056

Device Classification Name

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510(K) Number DEN160056
Device Name Philips IntelliSite Pathology Solution
Applicant Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best 5684 PC NL
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Contact Esther Abels
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Regulation Number

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Classification Product Code PSY
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Date Received 12/01/2016
Decision Date 04/12/2017
Decision DENG -
Classification Advisory Committee PA - Pathology
Review Advisory Committee PA - Pathology
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review



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