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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K882309
Device Name THE DIRECTION DIAL
Applicant
Lawhorn Innovations
218 E. Front St., Suite 302
Missoula,  MT  59802
Applicant Contact TIMOTHY M LAWHORN
Correspondent
Lawhorn Innovations
218 E. Front St., Suite 302
Missoula,  MT  59802
Correspondent Contact TIMOTHY M LAWHORN
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received06/03/1988
Decision Date 06/23/1988
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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