Clearance Summary
CAPSULE TENSION RING INSERTER, MODEL 7-810 received FDA 510(k) clearance under submission number K042478, 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 2004-12-28.
- Submission: K042478
- Applicant / Sponsor: Duckworth & Kent, Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2004-12-28
Classification & Regulation
This clearance is catalogued under FDA product code NCE and 21 CFR 886.4300, within the Ophthalmic review panel as a Class I device.