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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Other Noble Metal
510(k) Number K021367
Device Name STERNGOLD 66, MODEL #1180230
Applicant
Sterngold
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Applicant Contact MARIA RAO
Correspondent
Sterngold
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Correspondent Contact MARIA RAO
Regulation Number872.3060
Classification Product Code
EJS  
Date Received04/30/2002
Decision Date 05/16/2002
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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