Clearance Summary
SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 received FDA 510(k) clearance under submission number K100139, sponsored by Safelife Corp.. 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 2010-05-04.
- Submission: K100139
- Applicant / Sponsor: Safelife Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2010-05-04
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.