Clearance Summary
EYELID SPECULUM received FDA 510(k) clearance under submission number K830430, sponsored by Douglas C. Mckee & 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 1983-06-10.
- Submission: K830430
- Applicant / Sponsor: Douglas C. Mckee & Co.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1983-06-10
Classification & Regulation
This clearance is catalogued under FDA product code HNC and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.