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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 K913464
Device Name STOMAVISION (STV)
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 Number872.6640
Classification Product Code
EIA  
Date Received08/05/1991
Decision Date 11/13/1991
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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