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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Gold-Based Noble Metal
510(k) Number K983082
Device Name BEGOCER G
Applicant
Bego U.S.A.
1088 Main St. Suite 200
Pawtucket,  RI  02860
Applicant Contact WILLIAM OREMUS
Correspondent
Bego U.S.A.
1088 Main St. Suite 200
Pawtucket,  RI  02860
Correspondent Contact WILLIAM OREMUS
Regulation Number872.3060
Classification Product Code
EJT  
Date Received09/02/1998
Decision Date 10/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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