CareGUARD Sterilization Wrap
K-Number: K213907 · 2022-03-14
ApplicantCare Essentials Pty, Ltd.
Decision Date2022-03-14
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
CareGUARD Sterilization Wrap is a medical device manufactured by Care Essentials Pty, Ltd.. It received FDA 510(k) clearance on 2022-03-14 under approval number K213907. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CareGUARD Sterilization Wrap?
CareGUARD Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2022-03-14. It is manufactured by Care Essentials Pty, Ltd.. The 510(k) number is K213907.
When was CareGUARD Sterilization Wrap approved by the FDA?
CareGUARD Sterilization Wrap received FDA 510(k) clearance on 2022-03-14, under approval number K213907.
What company makes CareGUARD Sterilization Wrap?
CareGUARD Sterilization Wrap is manufactured by Care Essentials Pty, Ltd..
What is the FDA product code for CareGUARD Sterilization Wrap?
The FDA product code for CareGUARD Sterilization Wrap is FRG.
Other Devices by Care Essentials Pty, Ltd.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.