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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 K103659
Device Name CS 9300, CS 9300C
Applicant
Trophy
4 Rue F. Pelloutier Croissy
Beaubourg
Marne La Vallee Cedex 2,  FR 77437
Applicant Contact MARIE-PIERRE LABAT-CAMY
Correspondent
Trophy
4 Rue F. Pelloutier Croissy
Beaubourg
Marne La Vallee Cedex 2,  FR 77437
Correspondent Contact MARIE-PIERRE LABAT-CAMY
Regulation Number892.1750
Classification Product Code
OAS  
Date Received12/15/2010
Decision Date 08/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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