Clearance Summary
AMOILS EPITHELIAL SCRUBBER received FDA 510(k) clearance under submission number K962989, sponsored by S. Percy Amoils. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1997-01-09.
- Submission: K962989
- Applicant / Sponsor: S. Percy Amoils
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4070
- Decision date: 1997-01-09
Classification & Regulation
This clearance is catalogued under FDA product code HOG and 21 CFR 886.4070, within the Ophthalmic review panel as a Class I device.