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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 K973442
Device Name TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
Applicant
Medelec, Inc. D.B.A. Teca Corp.
3 Campus Dr.
Pleasantville,  NY  10570
Applicant Contact JIM HURLMAN
Correspondent
Medelec, Inc. D.B.A. Teca Corp.
3 Campus Dr.
Pleasantville,  NY  10570
Correspondent Contact JIM 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
Predetermined Change
Control Plan Authorized		 No
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