Clearance Summary
CENTURION SES EPIKERATOME received FDA 510(k) clearance under submission number K042810, sponsored by Norwood Abbey , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2004-10-28.
- Submission: K042810
- Applicant / Sponsor: Norwood Abbey , Ltd.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4370
- Decision date: 2004-10-28
Classification & Regulation
This clearance is catalogued under FDA product code HNO and 21 CFR 886.4370, within the Ophthalmic review panel as a Class I device.