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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 K994175
Device Name MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE
Applicant
Sodemsystems
110 Ch. Du Pont Du Centenaire
Geneva,  CH CH-1228
Applicant Contact DANIEL BACCINO
Correspondent
Sodemsystems
110 Ch. Du Pont Du Centenaire
Geneva,  CH CH-1228
Correspondent Contact DANIEL BACCINO
Regulation Number882.4370
Classification Product Code
HBB  
Date Received12/10/1999
Decision Date 12/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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