FDA 510(k) Application Details - K130816

Device Classification Name Electrode, Cutaneous

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510(K) Number K130816
Device Name Electrode, Cutaneous
Applicant NEURO RESOURCE GROUP, INC.
1100 JUPITER RD., STE. 190
PLANO, TX 75074 US
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Contact DAVID TURNER
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 03/25/2013
Decision Date 06/21/2013
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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