Clearance Summary
OPHTHALMIC LIGHT PIPE PICK received FDA 510(k) clearance under submission number K875195, sponsored by Trek Medical Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1988-03-07.
- Submission: K875195
- Applicant / Sponsor: Trek Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4580
- Decision date: 1988-03-07
Classification & Regulation
This clearance is catalogued under FDA product code FST and 21 CFR 878.4580, within the General, Plastic Surgery review panel as a Class II device.