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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 K904401
Device Name BATTERY-POWERED TOOTHBRUSH
Applicant
The B & F System, Inc.
3920 S. Walton Walker Blvd.
Dallas,  TX  75236
Applicant Contact DEBORA ZARATE
Correspondent
The B & F System, Inc.
3920 S. Walton Walker Blvd.
Dallas,  TX  75236
Correspondent Contact DEBORA ZARATE
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received09/25/1990
Decision Date 12/07/1990
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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