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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
Recalls CDRH Recalls
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