Clearance Summary
STERILE EYE SURGERY KITS received FDA 510(k) clearance under submission number K842990, sponsored by Biological & Environmental Control Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1985-05-09.
- Submission: K842990
- Applicant / Sponsor: Biological & Environmental Control Laboratories
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4790
- Decision date: 1985-05-09
Classification & Regulation
This clearance is catalogued under FDA product code HOZ and 21 CFR 886.4790, within the Ophthalmic review panel as a Class II device.