FDA 510(k) Application Details - K103103

Device Classification Name Electrode, Needle

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510(K) Number K103103
Device Name Electrode, Needle
Applicant PERSYST DEVELOPMENT CORP.
3177 CLEARWATER DRIVE
PRESCOTT, AZ 86305 US
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Contact SCOTT B WILSON
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Regulation Number 882.1350

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Classification Product Code GXZ
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Date Received 10/20/2010
Decision Date 12/08/2011
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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