FDA 510(k) Application Details - K955445

Device Classification Name Device, Caries Detection

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510(K) Number K955445
Device Name Device, Caries Detection
Applicant DANVILLE ENGINEERING, INC.
1901 SAN RAMON VALLEY BLVD.
SAN RAMON, CA 94583 US
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Contact CRAIG R BRUNS
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Regulation Number 872.1740

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Classification Product Code LFC
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Date Received 11/29/1995
Decision Date 02/08/1996
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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