Clearance Summary
GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING received FDA 510(k) clearance under submission number K001125, sponsored by Geuder GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2000-10-04.
- Submission: K001125
- Applicant / Sponsor: Geuder GmbH
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2000-10-04
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.