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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 K012456
Device Name SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
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 Received08/01/2001
Decision Date 09/21/2001
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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