Clearance Summary
LENS SET, MENTOR TRIAL received FDA 510(k) clearance under submission number K770389, sponsored by Codman & Shurtleff, 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 1977-03-14.
- Submission: K770389
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1405
- Decision date: 1977-03-14
Classification & Regulation
This clearance is catalogued under FDA product code HPC and 21 CFR 886.1405, within the Ophthalmic review panel as a Class I device.