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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Positioner, Tooth, Preformed
510(k) Number K891328
Device Name PREFORMED TEMPLATE FOR TOOTH POSITIONER
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 Number872.5525
Classification Product Code
KMY  
Date Received03/10/1989
Decision Date 03/31/1989
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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