Clearance Summary
ACTIPROTECT UF N95 RESPIRATOR received FDA 510(k) clearance under submission number K093161, sponsored by Glaxosmithkline Consumer Healthcare. 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 2010-05-10.
- Submission: K093161
- Applicant / Sponsor: Glaxosmithkline Consumer Healthcare
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2010-05-10
Classification & Regulation
This clearance is catalogued under FDA product code ONT and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.