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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 K964567
Device Name EL DORADO 75
Applicant
Gateway Alloys, Inc.
1702 Scherer Pkwy.
St. Charles,  MO  63303
Applicant Contact JOHN C CONSTANTINE
Correspondent
Gateway Alloys, Inc.
1702 Scherer Pkwy.
St. Charles,  MO  63303
Correspondent Contact JOHN C CONSTANTINE
Regulation Number872.3060
Classification Product Code
EJT  
Date Received11/14/1996
Decision Date 12/06/1996
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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