Clearance Summary
MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 received FDA 510(k) clearance under submission number K911160, sponsored by Mentor O & O, 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 1991-05-02.
- Submission: K911160
- Applicant / Sponsor: Mentor O & O, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 1991-05-02
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.