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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 K862224
Device Name THE WOOG AND THE WOOG D. POWERED TOOTHBRUSHES
Applicant
Xouth, Inc.
69 Charles St.
Suite 1
New York,  NY  10014
Applicant Contact PHILLIPE-GUY E WOOG
Correspondent
Xouth, Inc.
69 Charles St.
Suite 1
New York,  NY  10014
Correspondent Contact PHILLIPE-GUY E WOOG
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received06/11/1986
Decision Date 09/26/1986
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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