Surgical Mask-Model Number: Ear Loop, Flat-Pleated
K-Number: K201852 · 2021-03-02
Decision Date2021-03-02
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical Mask-Model Number: Ear Loop, Flat-Pleated is a medical device manufactured by Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2021-03-02 under approval number K201852. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Surgical Mask-Model Number: Ear Loop, Flat-Pleated?
Surgical Mask-Model Number: Ear Loop, Flat-Pleated is a medical device that received FDA 510(k) clearance on 2021-03-02. It is manufactured by Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K201852.
When was Surgical Mask-Model Number: Ear Loop, Flat-Pleated approved by the FDA?
Surgical Mask-Model Number: Ear Loop, Flat-Pleated received FDA 510(k) clearance on 2021-03-02, under approval number K201852.
What company makes Surgical Mask-Model Number: Ear Loop, Flat-Pleated?
Surgical Mask-Model Number: Ear Loop, Flat-Pleated is manufactured by Huizhou Foryou Medical Devices Co., Ltd..
What is the FDA product code for Surgical Mask-Model Number: Ear Loop, Flat-Pleated?
The FDA product code for Surgical Mask-Model Number: Ear Loop, Flat-Pleated is FXX.
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Related Devices (Code: FXX)
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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.