Name: Predicase
Price: 199 USD

K-number	K233801
Device name	Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
Applicant	Boston Scientific Neuromodulation
Product code	GZB
Device class	Class II
Decision date	Aug 23, 2024
Decision	Substantially Equivalent
Regulation	882.5880

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Source

View the full FDA submission: accessdata.fda.gov

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Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation

Everything you need for a 510(k) submission. Nothing you don't.