Clearance Summary
Single-Use Surgical Mask Model FE2311B received FDA 510(k) clearance under submission number K210970, sponsored by Byd Precison Manufacturer Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2021-07-21.
- Submission: K210970
- Applicant / Sponsor: Byd Precison Manufacturer Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2021-07-21
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.