Clearance Summary
ivi N3003 Surgical face Mask, ivi N6006 Surgical mask received FDA 510(k) clearance under submission number K201896, sponsored by Iob Medical, 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 2021-03-30.
- Submission: K201896
- Applicant / Sponsor: Iob Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2021-03-30
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.