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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 K020907
Device Name NEUROLINE, SUBDERMAL NEEDLE ELECTRODES
Applicant
MEDICOTEST A/S
1800 MASSCHUSETTS AVE., N.W.
SUITE 200
WASHINGTON,  DC  20036 -1221
Applicant Contact EMALEE G MURPHY
Correspondent
MEDICOTEST A/S
1800 MASSCHUSETTS AVE., N.W.
SUITE 200
WASHINGTON,  DC  20036 -1221
Correspondent Contact EMALEE G MURPHY
Regulation Number890.1385
Classification Product Code
IKT  
Subsequent Product Code
GXZ  
Date Received03/20/2002
Decision Date 06/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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