FDA 510(k) Application Details - K140200

Device Classification Name Electrode, Needle

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510(K) Number K140200
Device Name Electrode, Needle
Applicant NEUROINVENT INC.
5F,NO.123,ANMEI ST.,NEIHU DISTRICT,
TAIPEI CITY 11484 TW
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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 01/27/2014
Decision Date 07/18/2014
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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