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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Caries Detection
510(k) Number K030807
Device Name CARIES INDICATOR
Applicant
Confi-Dental Products Co.
416 S. Taylor Ave.
Louisville,  CO  80027
Applicant Contact STEPHEN RUDOLPH
Correspondent
Confi-Dental Products Co.
416 S. Taylor Ave.
Louisville,  CO  80027
Correspondent Contact STEPHEN RUDOLPH
Regulation Number872.1740
Classification Product Code
LFC  
Date Received03/13/2003
Decision Date 06/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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