Clearance Summary
AMNIOLENS received FDA 510(k) clearance under submission number K032104, sponsored by Bio-Tissue, 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 2003-12-12.
- Submission: K032104
- Applicant / Sponsor: Bio-Tissue, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.3130
- Decision date: 2003-12-12
Classification & Regulation
This clearance is catalogued under FDA product code NQB and 21 CFR 886.3130, within the Ophthalmic review panel as a Class II device.