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FDA 510(k) Application Details - DEN160056
Device Classification Name
More FDA Info for this Device
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
Other 510(k) Applications for this Device
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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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