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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
510(k) Number K130220
Device Name MR CONDITIONAL PRESSON ELECTRODE
Applicant
Rhythmlink International, LLC
1140 First St. S.
Columbia,  SC  29209
Applicant Contact JAMES M MEWBORNE
Correspondent
Rhythmlink International, LLC
1140 First St. S.
Columbia,  SC  29209
Correspondent Contact JAMES M MEWBORNE
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received01/29/2013
Decision Date 07/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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