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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 K882532
Device Name STAR ALLOYS, LITE ALLOYS AND BRITE ALLOYS
Applicant
Five Stars Alloys , Ltd.
P.O. Box 96
310 Argyle Rd.
Cedarhurst,  NY  11516
Applicant Contact JOSEPH J TUCCILLO
Correspondent
Five Stars Alloys , Ltd.
P.O. Box 96
310 Argyle Rd.
Cedarhurst,  NY  11516
Correspondent Contact JOSEPH J TUCCILLO
Regulation Number872.3060
Classification Product Code
EJT  
Date Received06/21/1988
Decision Date 10/19/1988
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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