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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 K190874
Device Name Materialise Mimics Enlight
Applicant
Materialise N.V.
Technologielaan 15
Leuven,  BE 3001
Applicant Contact Mieke Janssen
Correspondent
Materialise N.V.
Technologielaan 15
Leuven,  BE 3001
Correspondent Contact Mieke Janssen
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/04/2019
Decision Date 06/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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