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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 K203364
Device Name MDPC-8127
Applicant
Barco NV
President Kennedypark 35
Kortrijk,  BE 8500
Applicant Contact Lieven De Wandel
Correspondent
Barco NV
President Kennedypark 35
Kortrijk,  BE 8500
Correspondent Contact Lieven De Wandel
Regulation Number864.3700
Classification Product Code
PSY  
Subsequent Product Code
PZZ  
Date Received11/16/2020
Decision Date 04/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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