FDA 510(k) Application Details - K972534

Device Classification Name Alloy, Other Noble Metal

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510(K) Number K972534
Device Name Alloy, Other Noble Metal
Applicant AALBA DENT, INC.
400 WATT DR.
CORDELIA, CA 94534 US
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Contact VINCENT M BENETTI
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Regulation Number 872.3060

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Classification Product Code EJS
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Date Received 07/07/1997
Decision Date 09/05/1997
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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