Clearance Summary
ACTIPROTECT UC N95 RESPIRATOR received FDA 510(k) clearance under submission number K093189, sponsored by Glaxosmithkline Consumer Healthcare. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2010-07-02.
- Submission: K093189
- Applicant / Sponsor: Glaxosmithkline Consumer Healthcare
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6260
- Decision date: 2010-07-02
Classification & Regulation
This clearance is catalogued under FDA product code ORW and 21 CFR 880.6260, within the General Hospital review panel as a Class II device.