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FDA 510(k) Application Details - K111462
Device Classification Name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
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510(K) Number
K111462
Device Name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
Applicant
ANULEX TECHNOLOGIES, INC
5600 ROWLAND ROAD, STE 280
MINNETONKA, MN 55343 US
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Contact
RACHEL KENNEDY
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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
05/26/2011
Decision Date
09/08/2011
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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