FDA 510(k) Application Details - K072736

Device Classification Name Stimulator, Nerve

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510(K) Number K072736
Device Name Stimulator, Nerve
Applicant RHYTHMLINK INTERNATIONAL, LLC
1256 FIRST ST. SOUTH EXTENSION
COLUMBIA, SC 29209 US
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Contact JAMES MEWBORNE
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Regulation Number 874.1820

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Classification Product Code ETN
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Date Received 09/27/2007
Decision Date 01/22/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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