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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 K121165
Device Name BEAM BRUSH/BEAM APP
Applicant
Beam Technologies, LLC
P.O. Box 17541
Louisville,  KY  40217
Applicant Contact ALEX CURRY
Correspondent
Beam Technologies, LLC
P.O. Box 17541
Louisville,  KY  40217
Correspondent Contact ALEX CURRY
Regulation Number872.6855
Classification Product Code
EFW  
Date Received04/17/2012
Decision Date 06/21/2012
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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