FDA 510(k) Application Details - K964713

Device Classification Name Alloy, Other Noble Metal

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510(K) Number K964713
Device Name Alloy, Other 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 EJS
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Date Received 11/25/1996
Decision Date 12/16/1996
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 N
Expedited Review



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