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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 K133406
Device Name CS 8100 3D
Applicant
Trophy
4 Rue F. Pelloutier Croissy
Beaubourg
Marne La Vallee Cedex 2,  FR 77437
Applicant Contact MARIE PIERRE
Correspondent
Trophy
4 Rue F. Pelloutier Croissy
Beaubourg
Marne La Vallee Cedex 2,  FR 77437
Correspondent Contact MARIE PIERRE
Regulation Number892.1750
Classification Product Code
OAS  
Subsequent Product Code
MUH  
Date Received11/06/2013
Decision Date 03/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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