FDA 510(k) Application Details - K983078

Device Classification Name Alloy, Other Noble Metal

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510(K) Number K983078
Device Name Alloy, Other Noble Metal
Applicant BEGO U.S.A.
1088 MAIN ST. SUITE 200
PAWTUCKET, RI 02860 US
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Contact WILLIAM OREMUS
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Regulation Number 872.3060

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Classification Product Code EJS
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Date Received 09/02/1998
Decision Date 10/23/1998
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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