Clearance Summary
LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL received FDA 510(k) clearance under submission number K884364, sponsored by Bausch & Lomb Pharmaceutical, 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 1988-11-29.
- Submission: K884364
- Applicant / Sponsor: Bausch & Lomb Pharmaceutical, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4750
- Decision date: 1988-11-29
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.