Clearance Summary
CORNEAL CUTTER AND ACCESSORIES received FDA 510(k) clearance under submission number K781411, 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 1978-09-20.
- Submission: K781411
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1978-09-20
Classification & Regulation
This clearance is catalogued under FDA product code HRH and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.