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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 K891528
Device Name M-65 GOLD BASE DENTAL ALLOY
Applicant
Macdonald Metals and Ceramics
13519 1/2 Alondra Blvd.
Santa Fe Springs,  CA  90670
Applicant Contact RONALD A MACDONALD
Correspondent
Macdonald Metals and Ceramics
13519 1/2 Alondra Blvd.
Santa Fe Springs,  CA  90670
Correspondent Contact RONALD A MACDONALD
Regulation Number872.3060
Classification Product Code
EJT  
Date Received03/17/1989
Decision Date 04/12/1989
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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