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FDA 510(k) Application Details - K011661
Device Classification Name
Alloy, Gold-Based Noble Metal
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510(K) Number
K011661
Device Name
Alloy, Gold-Based Noble Metal
Applicant
GATEWAY ALLOYS, INC.
1702 SCHERER PKWY.
ST. CHARLES, MO 63303 US
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Contact
JOHN C CONSTANTINE
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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
05/29/2001
Decision Date
08/27/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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