Clearance Summary
N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 received FDA 510(k) clearance under submission number K092824, sponsored by Alpha Protech, 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 2009-10-21.
- Submission: K092824
- Applicant / Sponsor: Alpha Protech, Inc.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2009-10-21
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.