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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 K863677
Device Name TRADITION HIGH SPEED HANDPIECE
Applicant
Midwest
901 W. Oakton St.
Des Plaines,  IL  60018
Applicant Contact JAMES E KETTNER
Correspondent
Midwest
901 W. Oakton St.
Des Plaines,  IL  60018
Correspondent Contact JAMES E KETTNER
Regulation Number872.4200
Classification Product Code
EFB  
Date Received09/19/1986
Decision Date 10/06/1986
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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