Clearance Summary
CHARLES IRRIGATING FUNDUS CONTACT LENS received FDA 510(k) clearance under submission number K760949, sponsored by Richard'S Medical Equip., 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 1976-11-11.
- Submission: K760949
- Applicant / Sponsor: Richard'S Medical Equip., Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1395
- Decision date: 1976-11-11
Classification & Regulation
This clearance is catalogued under FDA product code HJI and 21 CFR 886.1395, within the Ophthalmic review panel as a Class I device.