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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 K941243
Device Name ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH
Applicant
Oraline, Ltd.
7-B Old Colony Dr.
Westford,  MA  01886
Applicant Contact JAMES MARSHALL
Correspondent
Oraline, Ltd.
7-B Old Colony Dr.
Westford,  MA  01886
Correspondent Contact JAMES MARSHALL
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received03/15/1994
Decision Date 06/06/1994
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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