Clearance Summary
PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S received FDA 510(k) clearance under submission number K041855, sponsored by Aearo Co.. 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 2004-11-10.
- Submission: K041855
- Applicant / Sponsor: Aearo Co.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2004-11-10
Classification & Regulation
This clearance is catalogued under FDA product code MSH and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.