Clearance Summary
FYODOROV COLLAGEN CORNEAL SHIELD received FDA 510(k) clearance under submission number K862315, sponsored by Medical Technology Development Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1987-01-07.
- Submission: K862315
- Applicant / Sponsor: Medical Technology Development Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4750
- Decision date: 1987-01-07
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.