Clearance Summary
13-550,13-560 WESCOTT SCOSSORS (EYE) received FDA 510(k) clearance under submission number K851768, sponsored by Artiberia. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1985-06-20.
- Submission: K851768
- Applicant / Sponsor: Artiberia
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1985-06-20
Classification & Regulation
This clearance is catalogued under FDA product code HNF and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.