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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 K021741
Device Name CRITERTION, MODEL #1067511
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 Received05/28/2002
Decision Date 06/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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