FDA 510(k) Application Details - K033279

Device Classification Name Alloy, Gold-Based Noble Metal

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510(K) Number K033279
Device Name Alloy, Gold-Based Noble Metal
Applicant BEGO U.S.A.
24 ALBION RD. SUITE 103
LINCOLN, RI 02865 US
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Contact WILLIAM OREMUS
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Regulation Number 872.3060

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Classification Product Code EJT
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Date Received 10/10/2003
Decision Date 01/15/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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