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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 K973444
Device Name TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES
Applicant
MEDELEC, INC. D.B.A. TECA CORP.
3 CAMPUS DR.
PLEASANTVILLE,  NY  10570
Applicant Contact JAMES P HURLMAN
Correspondent
MEDELEC, INC. D.B.A. TECA CORP.
3 CAMPUS DR.
PLEASANTVILLE,  NY  10570
Correspondent Contact JAMES P HURLMAN
Regulation Number890.1385
Classification Product Code
IKT  
Date Received09/11/1997
Decision Date 11/20/1997
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
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