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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 K961013
Device Name DISPOSABLE NEEDLE ELECTRODE
Applicant
Medelec Intl. Corp.
Manor Way
Old Woking, Surrey Gu22 9ju
England,  GB
Applicant Contact JEFF HALL
Correspondent
Medelec Intl. Corp.
Manor Way
Old Woking, Surrey Gu22 9ju
England,  GB
Correspondent Contact JEFF HALL
Regulation Number890.1385
Classification Product Code
IKT  
Date Received03/13/1996
Decision Date 12/20/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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