Name: Predicase
Price: 199 USD

K-number	K183579
Device name	Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits
Applicant	Boston Scientific Neuromodulation
Product code	GZF
Device class	Class II
Decision date	Mar 29, 2019
Decision	Substantially Equivalent
Regulation	882.5870

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Source

View the full FDA submission: accessdata.fda.gov

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Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits

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