K-number	K202027
Device name	Balex bone Expander System
Applicant	Taeyeon Medical Co., Ltd.
Product code	HRX
Device class	Class II
Decision date	Feb 3, 2021
Decision	Substantially Equivalent
Regulation	888.1100

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Source

View the full FDA submission: accessdata.fda.gov

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Balex bone Expander System

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