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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Gold-Based Noble Metal
510(k) Number K905197
Device Name THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM
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 Number872.3060
Classification Product Code
EJT  
Date Received11/20/1990
Decision Date 12/27/1990
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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