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FDA 510(k) Application Details - K972642
Device Classification Name
Carver, Wax, Dental
More FDA Info for this Device
510(K) Number
K972642
Device Name
Carver, Wax, Dental
Applicant
ESTRAD B.V.
P.O. BOX 7007
DEERFIELD, IL 60015 US
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Contact
DANIEL KAMM
Other 510(k) Applications for this Contact
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
07/15/1997
Decision Date
01/26/1998
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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