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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K964860
Device Name MARK 20 AND MARK 25 HAND ENGINE CONTROLLER
Applicant
Bell Intl., Inc.
31 Edwards Ct.
Burlingame,  CA  94010
Applicant Contact DEWEY BELL
Correspondent
Bell Intl., Inc.
31 Edwards Ct.
Burlingame,  CA  94010
Correspondent Contact DEWEY BELL
Regulation Number872.4200
Classification Product Code
EBW  
Date Received12/04/1996
Decision Date 03/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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