Clearance Summary
MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 received FDA 510(k) clearance under submission number K020474, sponsored by Makrite Industries, Inc.. 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 2002-07-23.
- Submission: K020474
- Applicant / Sponsor: Makrite Industries, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2002-07-23
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.