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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 K771774
Device Name NEW BASE FOR ORTHODONTIC APPLIANCES
Applicant
Gac Intl., Inc.
185 Oval Dr.
Central Islip,  NY  11722
Applicant Contact MARK MANNI
Correspondent
Gac Intl., Inc.
185 Oval Dr.
Central Islip,  NY  11722
Correspondent Contact MARK MANNI
Regulation Number872.5410
Classification Product Code
EJF  
Date Received09/19/1977
Decision Date 09/30/1977
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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