FDA 510(k) Application Details - K071869

Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief

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510(K) Number K071869
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant EMSI
901 KING STREET
SUITE 200
ALEXANDRIA, VA 22331 US
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Contact CHERITA JAMES
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 07/06/2007
Decision Date 03/07/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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