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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spring, Orthodontic
510(k) Number K933542
Device Name MESIAL LOOP BAR
Applicant
Gac Intl., Inc.
185 Oval Dr.
Central Islip,  NY  11722
Applicant Contact ERNEST H BOHN
Correspondent
Gac Intl., Inc.
185 Oval Dr.
Central Islip,  NY  11722
Correspondent Contact ERNEST H BOHN
Regulation Number872.5410
Classification Product Code
ECO  
Date Received07/20/1993
Decision Date 08/05/1994
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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