Name: Predicase
Price: 199 USD

K-number	K210143
Device name	Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)
Applicant	Foshan Nanhai Plus Medical Co, Ltd.
Product code	FYA
Device class	Class II
Decision date	Jul 22, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)

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