Clearance Summary
OCU-GUARD AND OCU-GUARD SUPPLE received FDA 510(k) clearance under submission number K983581, sponsored by Bio-Vascular, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1998-11-06.
- Submission: K983581
- Applicant / Sponsor: Bio-Vascular, Inc.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.3340
- Decision date: 1998-11-06
Classification & Regulation
This clearance is catalogued under FDA product code HQX and 21 CFR 886.3340, within the Ophthalmic review panel as a Class II device.