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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Toothbrush, Ionic, Battery-Powered
510(k) Number K971639
Device Name PLUSTRON ION TOOTHBRUSH SYSTEM
Applicant
Sas Group, Inc.
220 White Plains Rd.
Tarrytown,  NY  10591
Applicant Contact MICHAEL D SOBO
Correspondent
Sas Group, Inc.
220 White Plains Rd.
Tarrytown,  NY  10591
Correspondent Contact MICHAEL D SOBO
Regulation Number872.6865
Classification Product Code
MMD  
Date Received05/02/1997
Decision Date 06/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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