Clearance Summary
TRI-STAR UNIVERSAL I/A PHACO PAK received FDA 510(k) clearance under submission number K953359, sponsored by Tri-Star Ophthalmic. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1995-10-17.
- Submission: K953359
- Applicant / Sponsor: Tri-Star Ophthalmic
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4670
- Decision date: 1995-10-17
Classification & Regulation
This clearance is catalogued under FDA product code HQC and 21 CFR 886.4670, within the Ophthalmic review panel as a Class II device.