FDA 510(k) Application Details - K991481

Device Classification Name Alloy, Amalgam

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510(K) Number K991481
Device Name Alloy, Amalgam
Applicant LANCER ORTHODONTICS, INC.
253 PAWNEE ST.
SAN MARCOS, CA 92069 US
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Contact DOUGLAS D MILLER
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Regulation Number 872.3070

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Classification Product Code EJJ
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Date Received 04/28/1999
Decision Date 08/11/1999
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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