Clearance Summary
TSE-ANDERSON MODIFIED LACRIMAL GROOV received FDA 510(k) clearance under submission number K840861, sponsored by Hansen Ophthalmic Development Lab. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1984-05-09.
- Submission: K840861
- Applicant / Sponsor: Hansen Ophthalmic Development Lab
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1984-05-09
Classification & Regulation
This clearance is catalogued under FDA product code HNL and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.