FDA 510(k) Application Details - K992649

Device Classification Name Remover, Crown

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510(K) Number K992649
Device Name Remover, Crown
Applicant J. MORITA USA, INC.
601 13TH STREET, N.W.
SUITE 500 NORTH
WASHINGTON, DC 20005 US
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Contact KEITH A BARRITT
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Regulation Number 872.4565

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Classification Product Code EIS
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Date Received 08/06/1999
Decision Date 10/29/1999
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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