Name: Predicase
Price: 199 USD

K-number	K211765
Device name	Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown
Applicant	Cardinal Health, LLC
Product code	FYA
Device class	Class II
Decision date	Nov 23, 2021
Decision	Substantially Equivalent
Regulation	878.4040

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown

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