Clearance Summary
RELIEF VALVE-HONAN INTRAOC. PRESSURE received FDA 510(k) clearance under submission number K820526, sponsored by The Lebanon Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1982-03-25.
- Submission: K820526
- Applicant / Sponsor: The Lebanon Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4610
- Decision date: 1982-03-25
Classification & Regulation
This clearance is catalogued under FDA product code LCC and 21 CFR 886.4610, within the Ophthalmic review panel as a Class II device.