Clearance Summary
SURGICAL MASKS received FDA 510(k) clearance under submission number K111559, sponsored by Shanghai Neo-Medical Import & Export 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 2011-09-16.
- Submission: K111559
- Applicant / Sponsor: Shanghai Neo-Medical Import & Export Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2011-09-16
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.