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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+
Applicant
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4 Rue F. Pelloutier
Croissy-Beaubourg,  FR 77435
Applicant Contact Marie-Pierre Labat-Camy
Correspondent
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4 Rue F. Pelloutier
Croissy-Beaubourg,  FR 77435
Correspondent Contact Marie-Pierre Labat-Camy
Regulation Number872.5470
Classification Product Code
PNN  
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
Predetermined Change
Control Plan Authorized		 No
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