K-number	K213844
Device name	Surgical Gown
Applicant	Bayteks Teknik Tekstil San. VE Tic. A.S.
Product code	FYA
Device class	Class II
Decision date	Feb 16, 2023
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Surgical Gown

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