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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 K935127
Device Name SOUTHLAND STERILE DENTAL SYSTEM
Applicant
Southland, Ltd.
505 Commerce Park Dr.
Suite H
Marietta,  GA  30060
Applicant Contact CHARLES E WALKER, JR.
Correspondent
Southland, Ltd.
505 Commerce Park Dr.
Suite H
Marietta,  GA  30060
Correspondent Contact CHARLES E WALKER, JR.
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received10/28/1993
Decision Date 07/28/1994
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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