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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 K941209
Device Name MY BEAT POWERED TOOTHBRUSH
Applicant
Sanwa Components USA, Inc.
6540 Lusk Blvd.
#C-265
San Diego,  CA  92121
Applicant Contact JAY STUP
Correspondent
Sanwa Components USA, Inc.
6540 Lusk Blvd.
#C-265
San Diego,  CA  92121
Correspondent Contact JAY STUP
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received03/14/1994
Decision Date 06/16/1994
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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