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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Toothbrush, Powered
510(k) Number K900766
Device Name EPI DENT TOOTHBRUSH
Applicant
Epi Mfg.
1120 G. St. NW
Washington,  DC  20005
Applicant Contact LAURA A COOMER
Correspondent
Epi Mfg.
1120 G. St. NW
Washington,  DC  20005
Correspondent Contact LAURA A COOMER
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received02/16/1990
Decision Date 05/15/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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