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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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More FDA Info for this Product Code
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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