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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Plastic, Orthodontic
510(k) Number K861965
Device Name UNITEK CERAMIC BRACKET SYSTEM
Applicant
Unitek Corp.
2724 S. Peck Rd.
Monrovia,  CA  91016
Applicant Contact JEROLD S HORN
Correspondent
Unitek Corp.
2724 S. Peck Rd.
Monrovia,  CA  91016
Correspondent Contact JEROLD S HORN
Regulation Number872.5470
Classification Product Code
DYW  
Date Received05/19/1986
Decision Date 06/09/1986
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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