FDA 510(k) Application Details - K130136

Device Classification Name Electrode, Needle

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510(K) Number K130136
Device Name Electrode, Needle
Applicant TECHNOMED EUROPE
AMERIKALAAN 71
MAASTRICHT AIRPORT 6199 AE NL
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Contact PIERRE VREULS
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Regulation Number 882.1350

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Classification Product Code GXZ
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Date Received 01/18/2013
Decision Date 07/19/2013
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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