K-number	K182268
Device name	EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)
Applicant	Flat Medical Co., Ltd.
Product code	FMF
Device class	Class II
Decision date	Apr 5, 2019
Decision	Substantially Equivalent
Regulation	880.5860

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View the full FDA submission: accessdata.fda.gov

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EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)

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