FDA 510(k) Application Details - K030526

Device Classification Name Stimulator, Electrical, Evoked Response

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510(K) Number K030526
Device Name Stimulator, Electrical, Evoked Response
Applicant SPINEVISION, INC.
3003 SUMMIT BLVD.
SUITE 1400
ATLANTA, GA 30319 US
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Contact LYNNETTE WHITAKER
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Regulation Number 882.1870

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Classification Product Code GWF
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Date Received 02/19/2003
Decision Date 12/29/2004
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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