K-number	K220435
Device name	SEJONG Surgical Gown Soft
Applicant	Sejong Healthcare Co., Ltd.
Product code	FYA
Device class	Class II
Decision date	Feb 10, 2023
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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SEJONG Surgical Gown Soft

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