Name: Predicase
Price: 199 USD

K-number	K203418
Device name	Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))
Applicant	Ningbo Ouhan Medical Device Co., Ltd.
Product code	FXX
Device class	Class II
Decision date	Sep 17, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))

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