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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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More FDA Info for this Product Code
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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