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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 K953707
Device Name MEDTROL DENTAL KIT
Applicant
Medtrol, Inc.
2126 Berwick
Inverness,  IL  60067
Applicant Contact BRUCE J SCHULLO
Correspondent
Medtrol, Inc.
2126 Berwick
Inverness,  IL  60067
Correspondent Contact BRUCE J SCHULLO
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received08/08/1995
Decision Date 01/04/1996
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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