The following data is part of a premarket notification filed by Oti Medical Llc. with the FDA for Oti Model Tls-60.
| Device ID | K951437 |
| 510k Number | K951437 |
| Device Name: | OTI MODEL TLS-60 |
| Classification | Set, Lens, Trial, Ophthalmic |
| Applicant | OTI MEDICAL LLC. 530 BERCUT DR. SUITER J Sacramento, CA 95814 |
| Contact | Will Markle |
| Correspondent | Will Markle OTI MEDICAL LLC. 530 BERCUT DR. SUITER J Sacramento, CA 95814 |
| Product Code | HPC |
| CFR Regulation Number | 886.1405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-27 |
| Decision Date | 1995-04-11 |