FDA 510(k) Application Details - K000852

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

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510(K) Number K000852
Device Name Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Applicant ADVANCED NEUROMODULATION SYSTEMS
6501 WINDCREST DRIVE SUITE 100
PLANO, TX 75024 US
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Contact RASHMI MOZA
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Regulation Number 882.5870

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Classification Product Code GZF
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Date Received 03/15/2000
Decision Date 01/19/2001
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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