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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 K061351
Device Name ORAL-B SONIC COMPLETE
Applicant
Braun GmbH
800 Boylston St.
Prudential Tower Bldg. Floor 46
Boston,  MA  02199
Applicant Contact AMANDA HEFFERNAN
Correspondent
Braun GmbH
800 Boylston St.
Prudential Tower Bldg. Floor 46
Boston,  MA  02199
Correspondent Contact AMANDA HEFFERNAN
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received05/15/2006
Decision Date 06/05/2006
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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