Name: Predicase
Price: 199 USD

K-number	K200824
Device name	Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown
Applicant	Cardinal Health200, LLC
Product code	FYA
Device class	Class II
Decision date	Jul 29, 2020
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown

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