FDA 510(k) Application Details - K051773

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

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510(K) Number K051773
Device Name Stimulator, Spinal-Cord, Implanted (Pain Relief)
Applicant MEDTRONIC INC.,NEUROLOGICAL DIVISION
710 MEDTRONIC PKWY.
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 07/01/2005
Decision Date 07/28/2005
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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