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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 K072736
Device Name RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT
Applicant
RHYTHMLINK INTERNATIONAL, LLC
1256 FIRST ST. SOUTH EXTENSION
COLUMBIA,  SC  29209
Applicant Contact JAMES MEWBORNE
Correspondent
RHYTHMLINK INTERNATIONAL, LLC
1256 FIRST ST. SOUTH EXTENSION
COLUMBIA,  SC  29209
Correspondent Contact JAMES MEWBORNE
Regulation Number874.1820
Classification Product Code
ETN  
Date Received09/27/2007
Decision Date 01/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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