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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, extraoral source, digital
510(k) Number K151087
Device Name CS 8100SC, CS8100SC Access
Applicant
TROPHY
4 RUE F. PELLOUTIER
CROISSY-BEAUBOURG,  FR 77435
Applicant Contact MARIE-PIERRE LABAT-CAMY
Correspondent
TROPHY
4 RUE F. PELLOUTIER
CROISSY-BEAUBOURG,  FR 77435
Correspondent Contact MARIE-PIERRE LABAT-CAMY
Regulation Number872.1800
Classification Product Code
MUH  
Date Received04/23/2015
Decision Date 08/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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