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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 K894358
Device Name LUMINA ORTHODONTIC BRACKET
Applicant
Ormco Corp.
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Applicant Contact FRANCES ZEE
Correspondent
Ormco Corp.
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Correspondent Contact FRANCES ZEE
Regulation Number872.5410
Classification Product Code
EJF  
Date Received07/14/1989
Decision Date 09/15/1989
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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