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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name caries detector, laser light, transmission
510(k) Number K043068
Device Name DIFOTI USB 2.0 SYSTEM
Applicant
ELECTRO-OPTICAL SCIENCES, INC.
1 BRIDGE ST. SUITE 15
IRVINGTON-ON HUDSON,  NY  10533
Applicant Contact MICHAEL GREENEBAUM
Correspondent
ELECTRO-OPTICAL SCIENCES, INC.
1 BRIDGE ST. SUITE 15
IRVINGTON-ON HUDSON,  NY  10533
Correspondent Contact MICHAEL GREENEBAUM
Regulation Number872.1745
Classification Product Code
NTK  
Date Received11/08/2004
Decision Date 12/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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