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FDA 510(k) Application Details - K140349
Device Classification Name
Varnish, Cavity
More FDA Info for this Device
510(K) Number
K140349
Device Name
Varnish, Cavity
Applicant
NANOVA BIOMATERIALS, INC.
3806 MOJAVE CT
COLUMBIA, MO 65202 US
Other 510(k) Applications for this Company
Contact
ANDREW RITTS
Other 510(k) Applications for this Contact
Regulation Number
872.3260
More FDA Info for this Regulation Number
Classification Product Code
LBH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/19/2014
Decision Date
09/22/2014
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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