Clearance Summary
MENTOR ANTERIOR SEGMENT VITRECTOR received FDA 510(k) clearance under submission number K890595, sponsored by Mentor O & O, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1989-04-17.
- Submission: K890595
- Applicant / Sponsor: Mentor O & O, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4150
- Decision date: 1989-04-17
Classification & Regulation
This clearance is catalogued under FDA product code HKP and 21 CFR 886.4150, within the Ophthalmic review panel as a Class II device.