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FDA 510(k) Application Details - K192259
Device Classification Name
More FDA Info for this Device
510(K) Number
K192259
Device Name
Philips IntelliSite Pathology Solution
Applicant
Philips Electronics Nederland B.V.
Veenpluis 6
Best 5684 PC NL
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Contact
Liselotte Kornmann
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Regulation Number
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Classification Product Code
PSY
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Date Received
08/21/2019
Decision Date
09/20/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PA - Pathology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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