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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retainer, Screw Expansion, Orthodontic
510(k) Number K912417
Device Name MOLAR DISTALIZING ASSEMBLY
Applicant
American Orthodontics
1714 Cambridge Ave.
Sheboygan,  WI  53081
Applicant Contact PAUL RIDDLE
Correspondent
American Orthodontics
1714 Cambridge Ave.
Sheboygan,  WI  53081
Correspondent Contact PAUL RIDDLE
Regulation Number872.5410
Classification Product Code
DYJ  
Date Received05/31/1991
Decision Date 12/20/1991
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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