FDA 510(k) Application Details - K010008

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

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510(K) Number K010008
Device Name Stimulator, Spinal-Cord, Implanted (Pain Relief)
Applicant MICRONET MEDICAL, INC.
1839 BUERKLE RD.
WHITE BEAR LAKE, MN 55110 US
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Contact CHARLES LEHMAN
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Regulation Number 882.5880

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Classification Product Code GZB
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Date Received 01/02/2001
Decision Date 07/16/2001
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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