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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 K121524
Device Name INSIGNIA
Applicant
ORMCO CORP.
1717 WEST COLLINS AVENUE
ORANGE,  CA  92867
Applicant Contact Wendy Garman
Correspondent
ORMCO CORP.
1717 WEST COLLINS AVENUE
ORANGE,  CA  92867
Correspondent Contact Wendy Garman
Regulation Number872.5470
Classification Product Code
DYW  
Subsequent Product Codes
EJF   NJM  
Date Received05/23/2012
Decision Date 08/09/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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