Name: Predicase
Price: 199 USD

K-number	K232806
Device name	HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)
Applicant	Owens & Minor (O&M) Halyard, Inc.
Product code	FXX
Device class	Class II
Decision date	Jun 7, 2024
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)

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