FDA 510(k) Application Details - K013993

Device Classification Name Carver, Wax, Dental

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510(K) Number K013993
Device Name Carver, Wax, Dental
Applicant STEPHEN M KORAL, DMD
2006 BROADWAY
BOULDER, CO 80302 US
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Contact STEPHEN M KORAL
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Regulation Number 872.4565

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Classification Product Code EIK
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Date Received 12/04/2001
Decision Date 02/22/2002
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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