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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Toothbrush, Manual
510(k) Number K020776
Device Name MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
Applicant
Coronet Group North America, LLC
181 Dixion Rd.
Queensbury,,  NY  12804
Applicant Contact THOMAS E FERARI
Correspondent
Coronet Group North America, LLC
181 Dixion Rd.
Queensbury,,  NY  12804
Correspondent Contact THOMAS E FERARI
Regulation Number872.6855
Classification Product Code
EFW  
Date Received03/11/2002
Decision Date 06/03/2002
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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