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FDA 510(k) Application Details - K043156
Device Classification Name
Laser,Fluorescence Caries Detection
More FDA Info for this Device
510(K) Number
K043156
Device Name
Laser,Fluorescence Caries Detection
Applicant
NEKS TECHNOLOGIES, INC.
208 BARRINGTON OVERLOOK DRIVE
DURHAM, NC 27703 US
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Contact
CHARLES H KYPER
Other 510(k) Applications for this Contact
Regulation Number
872.1745
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Classification Product Code
NBL
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More FDA Info for this Product Code
Date Received
11/15/2004
Decision Date
04/28/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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