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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 K874227
Device Name PLASTIC BRACKETS
Applicant
Advanced Orthodontics Systems, Inc.
2346 Flatbush Ave.
Brooklyn,  NY  11234
Applicant Contact LAWRENCE HERMANN,DDS
Correspondent
Advanced Orthodontics Systems, Inc.
2346 Flatbush Ave.
Brooklyn,  NY  11234
Correspondent Contact LAWRENCE HERMANN,DDS
Regulation Number872.5470
Classification Product Code
DYW  
Date Received10/16/1987
Decision Date 12/29/1987
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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