Clearance Summary
Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) received FDA 510(k) clearance under submission number K153409, sponsored by Protect U Guard, LLC. 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 2016-11-15.
- Submission: K153409
- Applicant / Sponsor: Protect U Guard, LLC
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2016-11-15
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.