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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 K112034
Device Name TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
Applicant
CAREFUSION 209, INC.
1850 Deming Way
Middleton,  WI  53562
Applicant Contact GLEN HERMANSON
Correspondent
CAREFUSION 209, INC.
1850 Deming Way
Middleton,  WI  53562
Correspondent Contact GLEN HERMANSON
Regulation Number890.1385
Classification Product Code
IKT  
Date Received07/15/2011
Decision Date 08/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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