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FDA 510(k) Application Details - K991784
Device Classification Name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
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510(K) Number
K991784
Device Name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
Applicant
ADVANCED NEUROMODULATION SYSTEMS
ONE ALLENTOWN PKWY.
ALLEN, TX 75002 US
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Contact
KATRYNA WARREN
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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
05/25/1999
Decision Date
06/24/1999
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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