Clearance Summary
DISPOSABLE SURGICAL FACE MASKS received FDA 510(k) clearance under submission number K812675, sponsored by Irema USA , 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 1981-10-13.
- Submission: K812675
- Applicant / Sponsor: Irema USA , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 1981-10-13
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.