FDA 510(k) Application Details - K062041

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

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510(K) Number K062041
Device Name Stimulator, Spinal-Cord, Implanted (Pain Relief)
Applicant MEDTRONIC INC.
710 MEDTRONIC PARKWAY
MAIL STOP LN145
MINNEAPOLIS, MN 55432 US
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Contact PAULA CORDERO
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Regulation Number 882.5880

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Classification Product Code GZB
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Date Received 07/19/2006
Decision Date 08/16/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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