FDA 510(k) Application Details - K963927

Device Classification Name Device, Caries Detection

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510(K) Number K963927
Device Name Device, Caries Detection
Applicant CENTRIX, INC.
770 RIVER RD.
SHELTON, CT 06484-5458 US
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Contact JOHN DISCKO
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Regulation Number 872.1740

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Classification Product Code LFC
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Date Received 09/10/1996
Decision Date 11/15/1996
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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