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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 K852179
Device Name CERAMIC ORTHODONIT APPLIANCE
Applicant
Gac Intl., Inc.
71 Mall Dr.
Commack,  NY  11725
Applicant Contact LEO A DOHN
Correspondent
Gac Intl., Inc.
71 Mall Dr.
Commack,  NY  11725
Correspondent Contact LEO A DOHN
Regulation Number872.5410
Classification Product Code
EJF  
Date Received05/20/1985
Decision Date 08/20/1985
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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