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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 K121347
Device Name PRESSON ELECTRODE
Original Applicant
RHYTHMLINK INTERNATIONAL, LLC
1140 first st. south
columbia,  SC  29209
Original Contact james mewborne
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received05/01/2012
Decision Date 07/12/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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