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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 K993851
Device Name SODEM PERFORATOR DRIVE
Applicant
Sodemsystems
110, Ch. Du Pont-Du-Centenaire
Geneva, Switzerland,  CH CH 1228
Applicant Contact DANIEL BACCINO
Correspondent
Sodemsystems
110, Ch. Du Pont-Du-Centenaire
Geneva, Switzerland,  CH CH 1228
Correspondent Contact DANIEL BACCINO
Regulation Number882.4370
Classification Product Code
HBB  
Date Received11/12/1999
Decision Date 12/27/1999
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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