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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 K990375
Device Name DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75
Applicant
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
TONSBAKKEN 16-18
SKOVLUNDE
COPENHAGEN,  DK DK-2740
Applicant Contact ANN-CHRISTINE JONSSON
Correspondent
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
TONSBAKKEN 16-18
SKOVLUNDE
COPENHAGEN,  DK DK-2740
Correspondent Contact ANN-CHRISTINE JONSSON
Regulation Number890.1385
Classification Product Code
IKT  
Date Received02/08/1999
Decision Date 03/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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