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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K023896
Device Name C-1890
Applicant
Anodia Systems
514 S. Third St.
Danville,  KY  40422
Applicant Contact THAD OVERMYER
Correspondent
Anodia Systems
514 S. Third St.
Danville,  KY  40422
Correspondent Contact THAD OVERMYER
Regulation Number872.6640
Classification Product Code
EIA  
Date Received11/22/2002
Decision Date 06/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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