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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 K070001
Device Name MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE
Applicant
Mti Precision Products
175 Oberlin Ave., N.
Lakewood,  NJ  08701
Applicant Contact TOD BRENNER
Correspondent
Mti Precision Products
175 Oberlin Ave., N.
Lakewood,  NJ  08701
Correspondent Contact TOD BRENNER
Regulation Number872.4200
Classification Product Code
EFB  
Date Received01/03/2007
Decision Date 02/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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