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FDA 510(k) Application Details - K031543
Device Classification Name
Alloy, Gold-Based Noble Metal
More FDA Info for this Device
510(K) Number
K031543
Device Name
Alloy, Gold-Based Noble Metal
Applicant
STAR REFINING PRECIOUS METALS SOUTH AFRICA
PO BOX 4341
CROFTON, MD 21114 US
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Contact
YOLANDA SMITH
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Regulation Number
872.3060
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Classification Product Code
EJT
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More FDA Info for this Product Code
Date Received
05/16/2003
Decision Date
05/30/2003
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
Y
Expedited Review
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