K-number	K222011
Device name	HandX Instrument - Monopolar Spatula
Applicant	Human Xtensions , Ltd.
Product code	GCJ
Device class	Class II
Decision date	Jan 12, 2023
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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HandX Instrument - Monopolar Spatula

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