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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthodontic software
510(k) Number K193390
Device Name CS Model+
4 Rue F. Pelloutier
Croissy-Beaubourg,  FR 77435
Applicant Contact Marie-Pierre Labat-Camy
4 Rue F. Pelloutier
Croissy-Beaubourg,  FR 77435
Correspondent Contact Marie-Pierre Labat-Camy
Regulation Number872.5470
Classification Product Code
Date Received12/06/2019
Decision Date 04/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No