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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 K091055
Device Name RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R
Applicant
RHYTHMLINK INTERNATIONAL, LLC
1256 FIRST ST. SOUTH EXTENSION
COLUMBIA,  SC  29209
Applicant Contact JAMES M MEWBORNE
Correspondent
RHYTHMLINK INTERNATIONAL, LLC
1256 FIRST ST. SOUTH EXTENSION
COLUMBIA,  SC  29209
Correspondent Contact JAMES M MEWBORNE
Regulation Number890.1385
Classification Product Code
IKT  
Date Received04/13/2009
Decision Date 06/23/2009
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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