FDA 510(k) Application Details - K031010

Device Classification Name Alloy, Gold-Based Noble Metal

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510(K) Number K031010
Device Name Alloy, Gold-Based Noble Metal
Applicant SB LUCIUS, INC.
9778 KATELLA AVE. STE. 205
ANAHEIM, CA 92804 US
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Contact DAE-KYU CHANG
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Regulation Number 872.3060

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Classification Product Code EJT
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Date Received 03/31/2003
Decision Date 06/25/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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