Name: Predicase
Price: 199 USD

K-number	K210705
Device name	Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3
Applicant	Defender Safety, Inc.
Product code	FXX
Device class	Class II
Decision date	May 6, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3

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