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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 K881789
Device Name MINILINE BRACKET
Applicant
Alexotek Co.
2440 Willamette St.
Eugene,  OR  97405
Applicant Contact WILDMAN, DDS
Correspondent
Alexotek Co.
2440 Willamette St.
Eugene,  OR  97405
Correspondent Contact WILDMAN, DDS
Regulation Number872.5410
Classification Product Code
EJF  
Date Received04/26/1988
Decision Date 06/01/1988
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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