Clearance Summary
KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT received FDA 510(k) clearance under submission number K801418, sponsored by Keeler Optical Products , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1980-07-21.
- Submission: K801418
- Applicant / Sponsor: Keeler Optical Products , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4170
- Decision date: 1980-07-21
Classification & Regulation
This clearance is catalogued under FDA product code HPS and 21 CFR 886.4170, within the Ophthalmic review panel as a Class II device.