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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bar, Preformed
510(k) Number K881133
Device Name 70-X/RVG (RADIOVISIOGRAPHY)
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 Number872.3165
Classification Product Code
EHO  
Date Received03/16/1988
Decision Date 07/20/1989
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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