FDA 510(k) Application Details - K013063

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

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510(K) Number K013063
Device Name Stimulator, Spinal-Cord, Implanted (Pain Relief)
Applicant MEDTRONIC NEUROLOGICAL
800 53RD AVE., N.E.
P.O. BOX 1250
MINNEAPOLIS, MN 55421 US
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Contact MONAYA LEE
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Regulation Number 882.5880

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Classification Product Code GZB
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Date Received 09/12/2001
Decision Date 12/11/2001
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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