FDA 510(k) Application Details - K960728

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

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510(K) Number K960728
Device Name Stimulator, Spinal-Cord, Implanted (Pain Relief)
Applicant NEUROMED, INC.
ONE ALLENTOWN PKWY.
ALLEN, TX 75002-4211 US
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Contact KRISTA OAKES
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Regulation Number 882.5880

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Classification Product Code GZB
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Date Received 02/22/1996
Decision Date 05/22/1996
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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