The following data is part of a premarket notification filed by Hansen Ophthalmic Development Lab with the FDA for Tse-anderson Modified Lacrimal Groov.
| Device ID | K840861 |
| 510k Number | K840861 |
| Device Name: | TSE-ANDERSON MODIFIED LACRIMAL GROOV |
| Classification | Probe, Lachrymal |
| Applicant | HANSEN OPHTHALMIC DEVELOPMENT LAB 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HNL |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-24 |
| Decision Date | 1984-05-09 |