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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K112435
Device Name RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
Applicant
RHYTHMLINK INTERNATIONAL, LLC
1140 FIRST STREET SOUTH
COLUMBIA,  SC  29209
Applicant Contact JAMES MEWBORNE
Correspondent
RHYTHMLINK INTERNATIONAL, LLC
1140 FIRST STREET SOUTH
COLUMBIA,  SC  29209
Correspondent Contact JAMES MEWBORNE
Regulation Number874.1820
Classification Product Code
ETN  
Date Received08/24/2011
Decision Date 09/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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