Clearance Summary
OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP received FDA 510(k) clearance under submission number K973552, sponsored by Bio-Vascular, 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 1997-12-16.
- Submission: K973552
- Applicant / Sponsor: Bio-Vascular, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.3320
- Decision date: 1997-12-16
Classification & Regulation
This clearance is catalogued under FDA product code MTZ and 21 CFR 886.3320, within the Ophthalmic review panel as a Class II device.