The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Landers-foulks Temp. Keratoprosthesis.
| Device ID | K842856 |
| 510k Number | K842856 |
| Device Name: | LANDERS-FOULKS TEMP. KERATOPROSTHESIS |
| Classification | Keratoprosthesis, Temporary Implant, Surgical Use |
| Applicant | OCULAR INSTRUMENTS, INC. 12100 NORTHUP WAY SUITE D Bellevue, WA 98005 |
| Contact | James P Erickson |
| Correspondent | James P Erickson OCULAR INSTRUMENTS, INC. 12100 NORTHUP WAY SUITE D Bellevue, WA 98005 |
| Product Code | MLP |
| CFR Regulation Number | 886.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-20 |
| Decision Date | 1984-12-18 |