Clearance Summary
Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) received FDA 510(k) clearance under submission number K173062, sponsored by V&Q Manufacturing Corporation. 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 2018-01-25.
- Submission: K173062
- Applicant / Sponsor: V&Q Manufacturing Corporation
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2018-01-25
Classification & Regulation
This clearance is catalogued under FDA product code FXX and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.