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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 K020949
Device Name APOLLO, MODEL 1124525
Applicant
Sterngold
23 Frank Mossberg Dr.
Attleboro,  MA  02703 -0967
Applicant Contact MARIA RAO
Correspondent
Sterngold
23 Frank Mossberg Dr.
Attleboro,  MA  02703 -0967
Correspondent Contact MARIA RAO
Regulation Number872.3060
Classification Product Code
EJT  
Date Received03/25/2002
Decision Date 04/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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