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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 K896874
Device Name DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12
Applicant
Dantec Medical, Inc.
1575 Eye St. NW
Washington,  DC  20005
Applicant Contact RICHARD MANTHEI
Correspondent
Dantec Medical, Inc.
1575 Eye St. NW
Washington,  DC  20005
Correspondent Contact RICHARD MANTHEI
Regulation Number890.1385
Classification Product Code
IKT  
Date Received12/08/1989
Decision Date 06/18/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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