Clearance Summary
PEREGRINE DIFFUSION LIGHT PIPE received FDA 510(k) clearance under submission number K950529, sponsored by Peregrine Surgical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1995-06-07.
- Submission: K950529
- Applicant / Sponsor: Peregrine Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1945
- Decision date: 1995-06-07
Classification & Regulation
This clearance is catalogued under FDA product code HJM and 21 CFR 886.1945, within the Ophthalmic review panel as a Class II device.