FDA 510(k) Application Details - K021118

Device Classification Name Electrode, Needle

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510(K) Number K021118
Device Name Electrode, Needle
Applicant CLASS A ENT.
P.O. BOX 401964-16039
SUITE C
HESPERIA, CA 92345 US
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Contact SAMANTHA L DRAPER
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Regulation Number 882.1350

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Classification Product Code GXZ
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Date Received 04/08/2002
Decision Date 05/28/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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