FDA 510(k) Application Details - K043068

Device Classification Name Caries Detector, Laser Light, Transmission

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510(K) Number K043068
Device Name Caries Detector, Laser Light, Transmission
Applicant ELECTRO-OPTICAL SCIENCES, INC.
1 BRIDGE ST. SUITE 15
IRVINGTON-ON HUDSON, NY 10533 US
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Contact MICHAEL GREENEBAUM
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Regulation Number 872.1745

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Classification Product Code NTK
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Date Received 11/08/2004
Decision Date 12/29/2004
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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