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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 K950993
Device Name BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH
Applicant
John O. Butler
4635 W Foster Ave.
Chicago,  IL  60630
Applicant Contact SCOTT KOEPSEL
Correspondent
John O. Butler
4635 W Foster Ave.
Chicago,  IL  60630
Correspondent Contact SCOTT KOEPSEL
Regulation Number872.6855
Classification Product Code
EFW  
Date Received03/03/1995
Decision Date 06/02/1995
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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