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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 K931966
Device Name DANTEC DISPOSABLE CONCENTRIC NEEDLE
Applicant
Dantec Medical, Inc.
1575 Eye St. NW
Washington,  DC  20005
Applicant Contact RICHARD D MANTHEI
Correspondent
Dantec Medical, Inc.
1575 Eye St. NW
Washington,  DC  20005
Correspondent Contact RICHARD D MANTHEI
Regulation Number890.1385
Classification Product Code
IKT  
Date Received04/21/1993
Decision Date 03/30/1994
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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