FDA 510(k) Application Details - K992629

Device Classification Name Varnish, Cavity

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510(K) Number K992629
Device Name Varnish, Cavity
Applicant CENTRIX, INC.
770 RIVER RD.
SHELTON, CT 06484-5458 US
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Contact JOHN DISCKO
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Regulation Number 872.3260

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Classification Product Code LBH
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Date Received 07/28/1999
Decision Date 10/22/1999
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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