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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 K911042
Device Name GAMMAT ELECTROFORMED GOLD COPING
Applicant
Gramm Surface Technology, Inc.
15763 Edgewood Dr.
Dumfries,  VA  22026
Applicant Contact KATHARINA G EVERETT
Correspondent
Gramm Surface Technology, Inc.
15763 Edgewood Dr.
Dumfries,  VA  22026
Correspondent Contact KATHARINA G EVERETT
Regulation Number872.3060
Classification Product Code
EJT  
Date Received03/08/1991
Decision Date 05/29/1991
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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