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FDA 510(k) Application Details - K001479
Device Classification Name
Alloy, Gold-Based Noble Metal
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510(K) Number
K001479
Device Name
Alloy, Gold-Based Noble Metal
Applicant
AUREX SA (PTY) LTD.
24 PLANTATION ROAD, EASTLEIGH
EDENVALE, GAUTENG 1610 ZA
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Contact
J. D DAVIS
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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
05/11/2000
Decision Date
06/21/2000
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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