Name: Predicase
Price: 199 USD

K-number	K210688
Device name	AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown
Applicant	O&M Halyard, Inc.
Product code	FYA
Device class	Class II
Decision date	Jul 21, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown

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