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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, peripheral nerve, implanted (pain relief)
510(k) Number K191435
Device Name IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4
Applicant
Nalu Medical, Inc.
2320 Faraday Ave. Suite 100
Carlsbad,  CA  92008
Applicant Contact Michele Chin-Purcell
Correspondent
Nalu Medical, Inc.
2320 Faraday Ave. Suite 100
Carlsbad,  CA  92008
Correspondent Contact Michele Chin-Purcell
Regulation Number882.5870
Classification Product Code
GZF  
Date Received05/30/2019
Decision Date 09/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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