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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, Electric
510(k) Number K012457
Device Name SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)
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 Number882.4360
Classification Product Code
HBC  
Subsequent Product Code
HBE  
Date Received08/01/2001
Decision Date 10/22/2001
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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