Name: Predicase
Price: 199 USD

K-number	K201732
Device name	Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On
Applicant	Dukal Corporation
Product code	FXX
Device class	Class II
Decision date	Feb 16, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On

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