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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 K932025
Device Name ION-IMPLANTED NEO SENTALLOY
Applicant
Gac Intl., Inc.
185 Oval Dr.
Central Islip,  NY  11722
Applicant Contact ERNEST BOHN
Correspondent
Gac Intl., Inc.
185 Oval Dr.
Central Islip,  NY  11722
Correspondent Contact ERNEST BOHN
Regulation Number872.5410
Classification Product Code
EJF  
Subsequent Product Code
DZC  
Date Received04/26/1993
Decision Date 09/13/1993
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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