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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Band, Elastic, Orthodontic
510(k) Number K926578
Device Name UNI-STICK PLASTIC LIGATURE, MODIFIED
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
ECI  
Date Received09/21/1992
Decision Date 03/31/1993
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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