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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K884653
Device Name RACESTYPTINE
Applicant
Specialites Septodont
Washington Sq.
1050 Connecticut Ave. NW
Washington,  DC  20036
Applicant Contact PETER S REICHERTZ
Correspondent
Specialites Septodont
Washington Sq.
1050 Connecticut Ave. NW
Washington,  DC  20036
Correspondent Contact PETER S REICHERTZ
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received11/07/1988
Decision Date 01/19/1989
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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