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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle, Diagnostic Electromyograph
510(k) Number K062437
Device Name DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED
Applicant
Technomed Europe
Amerikalaan 71
Maastricht-Airport,  NL 6199 AE
Applicant Contact RENE RONCKEN
Correspondent
Technomed Europe
Amerikalaan 71
Maastricht-Airport,  NL 6199 AE
Correspondent Contact RENE RONCKEN
Regulation Number890.1385
Classification Product Code
IKT  
Date Received08/11/2006
Decision Date 02/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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