K-number	K213907
Device name	CareGUARD Sterilization Wrap
Applicant	Care Essentials Pty, Ltd.
Product code	FRG
Device class	Class II
Decision date	Mar 14, 2022
Decision	Substantially Equivalent
Regulation	880.6850

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Source

View the full FDA submission: accessdata.fda.gov

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CareGUARD Sterilization Wrap

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