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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 K945248
Device Name HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH
Applicant
Hukuba Dental Corp.
914-1 Naazukar
Nagareyama Chiba,  JP 270-01
Applicant Contact LEE M EVANS
Correspondent
Hukuba Dental Corp.
914-1 Naazukar
Nagareyama Chiba,  JP 270-01
Correspondent Contact LEE M EVANS
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received10/27/1994
Decision Date 01/26/1995
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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