Clearance Summary
BIO-COR COLLAGEN CORNEAL SHIELD received FDA 510(k) clearance under submission number K944872, sponsored by Bausch & Lomb Healthcare and Optics Worldwide. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1995-07-26.
- Submission: K944872
- Applicant / Sponsor: Bausch & Lomb Healthcare and Optics Worldwide
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4750
- Decision date: 1995-07-26
Classification & Regulation
This clearance is catalogued under FDA product code MOE and 21 CFR 886.4750, within the Ophthalmic review panel as a Class I device.