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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Headgear, Extraoral, Orthodontic
510(k) Number K950121
Device Name FRANCE ORTHODONTIE
Applicant
FRANCE ORTHODONTIE
18 RUE GALPIN-THIOU
TOURS,  FR
Applicant Contact BERNARD FONDEUR
Correspondent
FRANCE ORTHODONTIE
18 RUE GALPIN-THIOU
TOURS,  FR
Correspondent Contact BERNARD FONDEUR
Regulation Number872.5500
Classification Product Code
DZB  
Date Received01/12/1995
Decision Date 03/08/1995
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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