Clearance Summary
MENTOR GEMINI HEMOSTATIC ERASER received FDA 510(k) clearance under submission number K971538, sponsored by Mentor Ophthalmics, 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 1997-07-14.
- Submission: K971538
- Applicant / Sponsor: Mentor Ophthalmics, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4115
- Decision date: 1997-07-14
Classification & Regulation
This clearance is catalogued under FDA product code HQO and 21 CFR 886.4115, within the Ophthalmic review panel as a Class II device.