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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Intraoral
510(k) Number K953936
Device Name ATLANTIS
Applicant
Trophy Radiologie
106, Rue De La Jarry
B.P. 20
Vincennes, Cedex (Paris),  FR 94307
Applicant Contact MARIE-PIERRE LABAT-CAMY
Correspondent
Trophy Radiologie
106, Rue De La Jarry
B.P. 20
Vincennes, Cedex (Paris),  FR 94307
Correspondent Contact MARIE-PIERRE LABAT-CAMY
Regulation Number872.1810
Classification Product Code
EAP  
Date Received08/21/1995
Decision Date 12/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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