Clearance Summary
DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 received FDA 510(k) clearance under submission number K081382, sponsored by Duckworth & Kent, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2008-10-23.
- Submission: K081382
- Applicant / Sponsor: Duckworth & Kent, Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2008-10-23
Classification & Regulation
This clearance is catalogued under FDA product code KYB and 21 CFR 886.4300, within the Ophthalmic review panel as a Class I device.