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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Nerve Conduction Velocity Measurement
510(k) Number K935017
Device Name TD50 ELECTROMYOGRAPH
Applicant
Medelec Intl. Corp.
Manor Way
Old Woking, Surrey Gu22 9ju
England,  GB
Applicant Contact J. B. HOLLOWAY
Correspondent
Medelec Intl. Corp.
Manor Way
Old Woking, Surrey Gu22 9ju
England,  GB
Correspondent Contact J. B. HOLLOWAY
Regulation Number882.1550
Classification Product Code
JXE  
Date Received10/19/1993
Decision Date 07/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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