Clearance Summary
Surgical Mask-Model Number: Ear Loop, Flat-Pleated received FDA 510(k) clearance under submission number K201852, sponsored by Huizhou Foryou Medical Devices Co., Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2021-03-02.
- Submission: K201852
- Applicant / Sponsor: Huizhou Foryou Medical Devices Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2021-03-02
Classification & Regulation
This clearance is catalogued under FDA product code FXX and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.