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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K012213
Device Name GULLIVER AND CLASSE A
Applicant
American Dental Technologies, Inc.
5555 Bear Ln.
Corpus Christi,  TX  78405
Applicant Contact JOHN VICKERS
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DONALD J SHERRATT
Regulation Number872.6640
Classification Product Code
EIA  
Date Received07/16/2001
Decision Date 08/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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