Nalu Neurostimulation SCS System

Stimulator, Spinal-cord, Implanted (pain Relief)

Nalu Medical, Inc

The following data is part of a premarket notification filed by Nalu Medical, Inc with the FDA for Nalu Neurostimulation Scs System.

Pre-market Notification Details

Device IDK201618
510k NumberK201618
Device Name:Nalu Neurostimulation SCS System
ClassificationStimulator, Spinal-cord, Implanted (pain Relief)
Applicant Nalu Medical, Inc 2320 Faraday Ave. Suite 100 Carlsbad,  CA  92008
ContactMichele Chin-purcell
CorrespondentPauline Lieu
Nalu Medical, Inc. 2320 Faraday Ave. Suite 100 Carlsbad,  CA  92008
Product CodeGZB  
CFR Regulation Number882.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-15
Decision Date2020-07-15

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