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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
Original Applicant
1717 west collins avenue
orange,  CA  92867
Original Contact wendy garman
Regulation Number872.5470
Classification Product Code
Subsequent Product Codes
Date Received05/23/2012
Decision Date 08/09/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No