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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) Number K850344
Device Name AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG
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
EGS  
Date Received01/28/1985
Decision Date 03/25/1985
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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