Name: Predicase
Price: 199 USD

K-number	K213970
Device name	D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply
Applicant	Danameco Medical Joint Stock Corporation
Product code	FXX
Device class	Class II
Decision date	Jan 23, 2022
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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D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply

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