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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, Extraoral With Timer
510(k) Number K851095
Device Name INTRAORAL DENTAL X-RAY SYSTEM 70-X
Applicant
Trophy Radiologie
106, Rue De La Jarry
B.P. 20
Vincennes, Cedex (Paris),  FR 94307
Applicant Contact JY SEVESTRE
Correspondent
Trophy Radiologie
106, Rue De La Jarry
B.P. 20
Vincennes, Cedex (Paris),  FR 94307
Correspondent Contact JY SEVESTRE
Regulation Number872.1800
Classification Product Code
EHD  
Date Received03/19/1985
Decision Date 09/03/1985
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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