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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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