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FDA 510(k) Application Details - K964172
Device Classification Name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
More FDA Info for this Device
510(K) Number
K964172
Device Name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
Applicant
MEDTRONIC VASCULAR
800 53RD AVENUE, NE
P.O. BOX 1250
MINNEAPOLIS, MN 55440-9087 US
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Contact
DAVID H MUELLER
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Regulation Number
882.5880
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Classification Product Code
GZB
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More FDA Info for this Product Code
Date Received
10/18/1996
Decision Date
07/03/1997
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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