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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 K852691
Device Name ODONTO TOOTHBRUSH
Applicant
Action Hygiene Products, Inc.
4000 Chesswood Dr.
Downsview, Ont.
Canada M3j 2b9,  CA
Applicant Contact MYERS
Correspondent
Action Hygiene Products, Inc.
4000 Chesswood Dr.
Downsview, Ont.
Canada M3j 2b9,  CA
Correspondent Contact MYERS
Regulation Number872.6855
Classification Product Code
EFW  
Date Received06/26/1985
Decision Date 09/27/1985
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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