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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bracket, metal, orthodontic
510(k) Number K890656
Device Name LIP BUMPER
Original Applicant
AMERICAN ORTHODONTICS
1714 cambridge ave.
sheboygan,  WI  53081
Original Contact paul riddle
Regulation Number872.5410
Classification Product Code
EJF  
Date Received02/08/1989
Decision Date 04/17/1989
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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