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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Orthodontic
510(k) Number K920850
Device Name GAC THUMB-SUCKING CONTROL APPLIANCE
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
DZC  
Date Received02/25/1992
Decision Date 08/24/1992
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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