FDA 510(k) Application Details - K965216

Device Classification Name Teeth, Porcelain

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510(K) Number K965216
Device Name Teeth, Porcelain
Applicant ARGEN PRECIOUS METALS, INC.
5855 OBERLIN DR.
SAN DIEGO, CA 92121-4718 US
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Contact PAUL J CASCONE
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Regulation Number 872.3920

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Classification Product Code ELL
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Date Received 12/30/1996
Decision Date 02/27/1997
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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