FDA 510(k) Application Details - K091993

Device Classification Name Stimulator, Spinal-Cord, Implanted (Pain Relief)

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510(K) Number K091993
Device Name Stimulator, Spinal-Cord, Implanted (Pain Relief)
Applicant ADVANCED NEUROMODULATION SYSTEMS, INC. (ANS INC.)
6901 PRESTON ROAD
PLANO, TX 75024 US
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Contact MIA M WARE
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Regulation Number 882.5880

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Classification Product Code GZB
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Date Received 07/02/2009
Decision Date 07/31/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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