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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K851136
Device Name TROPHY COMPACT - DENTAL UNIT
Applicant
Trophy Radiologie
106, Rue De La Jarry
B.P. 20
Vincennes, Cedex (Paris),  FR 94307
Applicant Contact SY SEVESTRE
Correspondent
Trophy Radiologie
106, Rue De La Jarry
B.P. 20
Vincennes, Cedex (Paris),  FR 94307
Correspondent Contact SY SEVESTRE
Regulation Number872.6640
Classification Product Code
EIA  
Date Received03/21/1985
Decision Date 07/31/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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