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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Drill, Pneumatic
510(k) Number K023066
Device Name DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)
Applicant
Sodemsystems
110 Ch. Du Pont Du Centenaire
Geneva,  CH CH-1228
Applicant Contact CAROLE BURNIER
Correspondent
Sodemsystems
110 Ch. Du Pont Du Centenaire
Geneva,  CH CH-1228
Correspondent Contact CAROLE BURNIER
Regulation Number882.4370
Classification Product Code
HBB  
Date Received09/16/2002
Decision Date 11/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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