Clearance Summary
PLEATS PLUS N95 RESPIRATOR, MODELS 1054 AND 1054S received FDA 510(k) clearance under submission number K063013, sponsored by Aearo Company. 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 2006-12-01.
- Submission: K063013
- Applicant / Sponsor: Aearo Company
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2006-12-01
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.