FDA 510(k) Application Details - K051010

Device Classification Name Alloy, Amalgam

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510(K) Number K051010
Device Name Alloy, Amalgam
Applicant SEPTODONT
1050 CONNECTICUT AVE., NW
WASHINGTON, DC 20036 US
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Contact WAYNE H MATELSKI
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Regulation Number 872.3070

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Classification Product Code EJJ
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Date Received 04/21/2005
Decision Date 05/02/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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