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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K223427
Device Name Mimics Enlight CMF
Applicant
Materialise N.V
Technologielaan 15
Leuven,  BE 3001
Applicant Contact Simona Beri
Correspondent
Materialise N.V
Technologielaan 15
Leuven,  BE 3001
Correspondent Contact Victoria Becheva
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
DZJ  
Date Received11/14/2022
Decision Date 05/31/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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