FDA 510(k) Application Details - K142470

Device Classification Name Electrode, Needle

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510(K) Number K142470
Device Name Electrode, Needle
Applicant NEUROINVENT INC.
19925 STEVENS CREEK BLVD., STE 100
CUPERTINO, CA 95014 US
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Contact CHAO SHENT-CHAO
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Regulation Number 882.1350

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Classification Product Code GXZ
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Date Received 09/03/2014
Decision Date 11/05/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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