COBO TEMPORARY KERATOPROSTHESIS
FDA 510(k) clearance K895013 · decided 1989-10-31
Clearance details
- K-number
- K895013
- Device name
- COBO TEMPORARY KERATOPROSTHESIS
- Applicant
- Ocular Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-08-08
- Decision date
- 1989-10-31
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- MLP
- Device class
- 2
- Regulation number
- 886.3400
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Bellevue, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Temporary Keratoprosthesis (QuickSet TKP™) (K261312) | Eyekon Medical, Inc. | 2026-07-24 |
| LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS (K910828) | Ocular Instruments, Inc. | 1991-08-21 |
| ECKHARDT TEMPORARY KERATOPROSTHESIS (K902491) | Dutch Ophthalmic USA, Inc. | 1990-06-26 |
| LANDERS-FOULKS TEMP. KERATOPROSTHESIS (K842856) | Ocular Instruments, Inc. | 1984-12-18 |
Recalls involving this device
No recalls on record reference this clearance.