FDA 510(k) Application Details - K033016

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

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510(K) Number K033016
Device Name Stimulator, Spinal-Cord, Implanted (Pain Relief)
Applicant MEDTRONIC NEUROLOGICAL
710 MEDTRONIC PARKWAY N.E.
LN 145
MINNEAPOLIS, MN 55432-5604 US
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Contact PAM SCHAUB
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Regulation Number 882.5880

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Classification Product Code GZB
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Date Received 09/26/2003
Decision Date 10/30/2003
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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