Clearance Summary
Communicator Surgical Facemask with Clear Window received FDA 510(k) clearance under submission number K152561, sponsored by Prestige Ameritech , Ltd.. 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 2016-06-03.
- Submission: K152561
- Applicant / Sponsor: Prestige Ameritech , Ltd.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2016-06-03
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.