Clearance Summary
WHITE PLUME SURGICAL GAUZE FACE MASK received FDA 510(k) clearance under submission number K870312, sponsored by China National Medicines & Health Prod. I/E Corp.. 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 1987-02-24.
- Submission: K870312
- Applicant / Sponsor: China National Medicines & Health Prod. I/E Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 1987-02-24
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.