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FDA 510(k) Application Details - K021131
Device Classification Name
Varnish, Cavity
More FDA Info for this Device
510(K) Number
K021131
Device Name
Varnish, Cavity
Applicant
CENTRIX, INC.
770 RIVER RD.
SHELTON, CT 06484-5458 US
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Contact
JOHN DISCKO
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
04/08/2002
Decision Date
09/26/2002
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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