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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 K141018
Device Name ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT
Applicant
PROCTER & GAMBLE CO.
8700 MASON-MONTGOMERY RD.
MASON,  OH  45040 -9462
Applicant Contact MICHAEL KAMINSKI, PH.D.
Correspondent
PROCTER & GAMBLE CO.
8700 MASON-MONTGOMERY RD.
MASON,  OH  45040 -9462
Correspondent Contact MICHAEL KAMINSKI, PH.D.
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received04/21/2014
Decision Date 09/15/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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