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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Imaging
510(k) Number K213957
Device Name Demetra Dermatoscope BDEM-01
Applicant
Barco N.V.
President Kennedypark 35
Kortrijk,  BE 8500
Applicant Contact Imke Storm
Correspondent
Barco N.V.
President Kennedypark 35
Kortrijk,  BE 8500
Correspondent Contact Imke Storm
Regulation Number878.4580
Classification Product Code
PSN  
Date Received12/17/2021
Decision Date 03/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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