FDA 510(k) Application Details - K063729

Device Classification Name Electrode, Needle

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510(K) Number K063729
Device Name Electrode, Needle
Applicant TECHNOMED EUROPE
AMERIKALAAN 71
MAASTRICHT AIRPORT 6199 AE NL
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Contact MAURICE ROOST
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Regulation Number 882.1350

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Classification Product Code GXZ
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Date Received 12/15/2006
Decision Date 08/21/2007
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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