K-number	K190811
Device name	Optimus NEURO System - Sterile Kit
Applicant	Osteonic Co., Ltd.
Product code	GWO
Device class	Class II
Decision date	Nov 27, 2019
Decision	Substantially Equivalent
Regulation	882.5320

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Source

View the full FDA submission: accessdata.fda.gov

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Optimus NEURO System - Sterile Kit

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