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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 K092973
Device Name DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE
Applicant
BIONEN S.A.S.
11460 N. MERIDIAN ST., STE 150
CARMEL,  IN  46032
Applicant Contact Allison Scott
Correspondent
BIONEN S.A.S.
11460 N. MERIDIAN ST., STE 150
CARMEL,  IN  46032
Correspondent Contact Allison Scott
Regulation Number890.1385
Classification Product Code
IKT  
Subsequent Product Code
GXZ  
Date Received09/25/2009
Decision Date 10/07/2010
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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