Name: Predicase
Price: 199 USD

K-number	K212293
Device name	Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)
Applicant	Jiangmen Ningrui Medical Supplies Co., Ltd.
Product code	FXX
Device class	Class II
Decision date	Oct 25, 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 (Model: WK1701-02A, WK1701-03A, WK1701-04A)

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