Clearance Summary
EYE IRRIGATOR MODEL #2020 received FDA 510(k) clearance under submission number K980647, sponsored by Eye-Deal Ocular Safety Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1998-05-15.
- Submission: K980647
- Applicant / Sponsor: Eye-Deal Ocular Safety Products, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4360
- Decision date: 1998-05-15
Classification & Regulation
This clearance is catalogued under FDA product code KYG and 21 CFR 886.4360, within the Ophthalmic review panel as a Class I device.