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FDA 510(k) Application Details - K981970
Device Classification Name
Material, Impression
More FDA Info for this Device
510(K) Number
K981970
Device Name
Material, Impression
Applicant
CAVEX HOLLAND B.V.
PO BOX 852
RW HAARLEM (HOLLAND) 2003 NL
Other 510(k) Applications for this Company
Contact
BERNARD VAN DUIJN
Other 510(k) Applications for this Contact
Regulation Number
872.3660
More FDA Info for this Regulation Number
Classification Product Code
ELW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/04/1998
Decision Date
09/02/1998
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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