Clearance Summary
BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013 received FDA 510(k) clearance under submission number K101128, sponsored by Filligent Limited. 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 2011-05-26.
- Submission: K101128
- Applicant / Sponsor: Filligent Limited
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2011-05-26
Classification & Regulation
This clearance is catalogued under FDA product code OUK and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.