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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 K012914
Device Name SONICWAVE SONIC PLAQUE REMOVER
Applicant
Homedics, Inc.
3000 Pontiac Trl.
Commerce Township,  MI  48390
Applicant Contact DAVID VANDERLIN
Correspondent
Homedics, Inc.
3000 Pontiac Trl.
Commerce Township,  MI  48390
Correspondent Contact DAVID VANDERLIN
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received08/30/2001
Decision Date 10/01/2001
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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