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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name x-ray, tomography, computed, dental
510(k) Number K200183
Device Name CS 9600
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 Number892.1750
Classification Product Code
Date Received01/24/2020
Decision Date 03/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls