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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Whole Slide Imaging System
510(k) Number K192259
Device Name Philips IntelliSite Pathology Solution
Applicant
Philips Electronics Nederland B.V.
Veenpluis 6
Best,  NL 5684PC
Applicant Contact Liselotte Kornmann
Correspondent
Philips Electronics Nederland B.V.
Veenpluis 6
Best,  NL 5684PC
Correspondent Contact Liselotte Kornmann
Regulation Number864.3700
Classification Product Code
PSY  
Date Received08/21/2019
Decision Date 09/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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