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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 K951074
Device Name STOMAVISION (STV)
Applicant
Trophy Radiologie
106, Rue De La Jarry
B.P. 20
Vincennes, Cedex (Paris),  FR 94307
Applicant Contact MARIE P LABAT-CAMY
Correspondent
Trophy Radiologie
106, Rue De La Jarry
B.P. 20
Vincennes, Cedex (Paris),  FR 94307
Correspondent Contact MARIE P LABAT-CAMY
Regulation Number872.6640
Classification Product Code
EIA  
Date Received03/09/1995
Decision Date 09/19/1995
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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