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FDA 510(k) Application Details - K183579
Device Classification Name
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
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510(K) Number
K183579
Device Name
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Applicant
Nalu Medical, Inc
1525 Faraday Ave. Suite 180
Carlsbad, CA 92008 US
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Contact
Michele Chin-Purcell
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Regulation Number
882.5870
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Classification Product Code
GZF
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More FDA Info for this Product Code
Date Received
12/21/2018
Decision Date
03/29/2019
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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