FDA 510(k) Application Details - K233204

Device Classification Name

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510(K) Number K233204
Device Name Philips IntelliSite Pathology Solution 5.1
Applicant Philips Medical Systems Nederland B.V.
Veenpluis 6
Best 5684PC 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 09/28/2023
Decision Date 06/24/2024
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

FDA Source Information for K233204


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