FDA 510(k) Application Details - K071446

Device Classification Name Electrode, Cutaneous

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510(K) Number K071446
Device Name Electrode, Cutaneous
Applicant ELECTRODE ARRAYS
612 N. RESLER
EL PASO, TX 79912 US
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Contact ELVIRA GARCIA
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 05/24/2007
Decision Date 07/02/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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