FDA 510(k) Application Details - K050922

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

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510(K) Number K050922
Device Name Stimulator, Spinal-Cord, Implanted (Pain Relief)
Applicant ADVANCED NEUROMODULATION SYSTEMS
6901 PRESTON RD.
PLANO, TX 75024 US
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Contact DANIELLE ALARCON
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Regulation Number 882.5880

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Classification Product Code GZB
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Date Received 04/13/2005
Decision Date 05/18/2005
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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