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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K072554
Device Name ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES
Applicant
Sable Industries, Inc.
581 Whiles Ct.
Erie,  CO  80516
Applicant Contact KEVIN RANDALL
Correspondent
Sable Industries, Inc.
581 Whiles Ct.
Erie,  CO  80516
Correspondent Contact KEVIN RANDALL
Regulation Number872.4200
Classification Product Code
EFB  
Date Received09/10/2007
Decision Date 11/14/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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