FDA 510(k) Application Details - K000105

Device Classification Name Stimulator, Peripheral Nerve, Implanted (Pain Relief)

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510(K) Number K000105
Device Name Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Applicant MEDTRONIC VASCULAR
11660 WAYZATA BLVD.
MINNETONKA, MN 55305 US
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Contact PAM SCHAUB
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Regulation Number 882.5870

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Classification Product Code GZF
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Date Received 01/14/2000
Decision Date 04/12/2000
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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