Clearance Summary
MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS received FDA 510(k) clearance under submission number K062663, sponsored by Moldex/Metric, Inc.. 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 2006-10-11.
- Submission: K062663
- Applicant / Sponsor: Moldex/Metric, Inc.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2006-10-11
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.