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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name drill, surgical, ent (electric or pneumatic) including handpiece
510(k) Number K023070
Device Name SODEM HIGH SPEED SYSTEM (PNEUMATIC)
Applicant
SODEM SYSTEMS
110 CH. DU PONT DU CENTENAIRE
GENEVA,  CH CH-1228
Applicant Contact CAROLE BURNIER
Correspondent
SODEM SYSTEMS
110 CH. DU PONT DU CENTENAIRE
GENEVA,  CH CH-1228
Correspondent Contact CAROLE BURNIER
Regulation Number874.4250
Classification Product Code
ERL  
Date Received09/16/2002
Decision Date 01/28/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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