Name: Predicase
Price: 199 USD

K-number	K221637
Device name	Surgical Gown (Sterile); Surgical Gown (Non-sterile)
Applicant	Allmed Medical (Hubei) Protective Products Co., Ltd.
Product code	FYA
Device class	Class II
Decision date	Sep 29, 2022
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 (Sterile); Surgical Gown (Non-sterile)

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