Name: Predicase
Price: 199 USD

K-number	K230610
Device name	Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)
Applicant	Dongguan Shin YI Healthcare Products Factory
Product code	FYA
Device class	Class II
Decision date	Aug 23, 2023
Decision	Substantially Equivalent
Regulation	878.4040

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)

Everything you need for a 510(k) submission. Nothing you don't.