Clearance Summary
CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 received FDA 510(k) clearance under submission number K002556, sponsored by Pharmacia & Upjohn Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2000-10-31.
- Submission: K002556
- Applicant / Sponsor: Pharmacia & Upjohn Co.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2000-10-31
Classification & Regulation
This clearance is catalogued under FDA product code MSS and 21 CFR 886.4300, within the Ophthalmic review panel as a Class I device.