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FDA 510(k) Application Details - K002675
Device Classification Name
Alloy, Gold-Based Noble Metal
More FDA Info for this Device
510(K) Number
K002675
Device Name
Alloy, Gold-Based Noble Metal
Applicant
PRODUCT DEVELOPMENT INDUSTRIES, INC.
4500 EAST SPEEDWAY BLVD., #50
TUCSON, AZ 85712 US
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Contact
RODOLFO A CARBALLO
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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
08/28/2000
Decision Date
10/25/2000
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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