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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 K852279
Device Name SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 4201
Applicant
Northern Electric Co. Div. of Sunbeam Corp.
5224 N. Kedzie
Chicago,  IL  60625
Applicant Contact SCHECK
Correspondent
Northern Electric Co. Div. of Sunbeam Corp.
5224 N. Kedzie
Chicago,  IL  60625
Correspondent Contact SCHECK
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received05/29/1985
Decision Date 07/01/1985
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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