MLP — Keratoprosthesis, Temporary Implant, Surgical Use Class II
FDA product code MLP covers "Keratoprosthesis, Temporary Implant, Surgical Use", a Class II medical device regulated under 21 CFR 886.3400. Submissions are reviewed by the Ophthalmic panel. Devices under this code are implants. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MLP
- Device Class
- Class II
- Regulation Number
- 886.3400
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K910828 | ocular instruments | LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS | August 21, 1991 |
| K902491 | dutch ophthalmic usa | ECKHARDT TEMPORARY KERATOPROSTHESIS | June 26, 1990 |
| K895013 | ocular instruments | COBO TEMPORARY KERATOPROSTHESIS | October 31, 1989 |
| K842856 | ocular instruments | LANDERS-FOULKS TEMP. KERATOPROSTHESIS | December 18, 1984 |