Clearance Summary
WELLMIEN SURGICAL MASK received FDA 510(k) clearance under submission number K101000, sponsored by Wellmien (Suzhou) Import & Export Trading 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 2010-08-09.
- Submission: K101000
- Applicant / Sponsor: Wellmien (Suzhou) Import & Export Trading Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2010-08-09
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.