FDA 510(k) Application Details - K033392

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K033392
Device Name Implant, Endosseous, Root-Form
Applicant "O" CO., INC.
600 PAISANO, N.E., SUITE A
ALBUQUERQUE, NM 87123 US
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Contact DAVID D DALISE
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 10/23/2003
Decision Date 12/10/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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