FDA 510(k) Application Details - K023466

Device Classification Name Material, Impression

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510(K) Number K023466
Device Name Material, Impression
Applicant CAVEX HOLLAND B.V.
PO BOX 852
HAARLEM (HOLLAND) 2003 RW NL
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Contact RICHARD WOORTMAN
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Regulation Number 872.3660

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Classification Product Code ELW
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Date Received 10/16/2002
Decision Date 12/13/2002
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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