Clearance Summary
Surgical Mask-Model Number CW01 received FDA 510(k) clearance under submission number K202354, sponsored by Hunan Heng Chang Pharmaceutical 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 2020-09-08.
- Submission: K202354
- Applicant / Sponsor: Hunan Heng Chang Pharmaceutical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2020-09-08
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.