FDA 510(k) Application Details - K033052

Device Classification Name Media, Electroconductive

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510(K) Number K033052
Device Name Media, Electroconductive
Applicant COMPUMEDICS USA, LTD.
7850 PASEO DEL NORTE
EL PASO, TX 79912 US
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Contact ELVIRA GARCIA
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Regulation Number 882.1275

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Classification Product Code GYB
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Date Received 09/29/2003
Decision Date 12/17/2003
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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