FDA 510(k) Application Details - K062996

Device Classification Name Electrode, Needle

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510(K) Number K062996
Device Name Electrode, Needle
Applicant AXON SYSTEMS, INC.
400-2200 OSER AVE.
HAUPPAUGE, NY 11788 US
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Contact HOWARD BAILIN
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Regulation Number 882.1350

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Classification Product Code GXZ
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Date Received 10/02/2006
Decision Date 01/12/2007
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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