Clearance Summary
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP received FDA 510(k) clearance under submission number K042267, sponsored by Inovel, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2004-09-30.
- Submission: K042267
- Applicant / Sponsor: Inovel, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2004-09-30
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.