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FDA 510(k) Application Details - K955445
Device Classification Name
Device, Caries Detection
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
872.1740
More FDA Info for this Regulation Number
Classification Product Code
LFC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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