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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 K003007
Device Name GALAXY
Applicant
Sterngold
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Applicant Contact SUSAN L SPEAR
Correspondent
Sterngold
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Correspondent Contact SUSAN L SPEAR
Regulation Number872.3060
Classification Product Code
EJT  
Date Received09/26/2000
Decision Date 11/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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