FDA Registration
Active
🇺🇸 United States
OLTK-6.2-Landers Wide Field Temporary Keratoprosthesis 6.2mm
Reg #: 3014865
·
FEI: 3014865
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OCULAR INSTRUMENTS, INC.
- Registration Number
- 3014865
- FEI Number
- 3014865
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2255 116TH AVE., N.E.
- City
- BELLEVUE
- State
- WA
- ZIP
- 98004
- Country
- US
Regulatory Submissions
- 510(k) Number
- K910828
Owner / Operator
- Firm Name
- OCULAR INSTRUMENTS
- Operator Number
- 3014865
- Address
- 2255 116TH AVE. N.E., --
- City
- Bellevue
- State
- WA
- Postal Code
- 98004
- Country
- US
- Correspondent
- Staci D Caldwell
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Keratoprosthesis, Temporary Implant, Surgical Use | MLP | Class 2 | Ophthalmic | No | 2007-11-26 |
Proprietary Names
OLTK-6.2-Landers Wide Field Temporary Keratoprosthesis 6.2mm
OLTK-8.2-Landers Wide Field Temporary Keratoprosthesis 8.2mm
OLTK-7.2-Landers Wide Field Temporary Keratoprosthesis 7.2mm
OLTCW-Landers Wide Field Corneal Window
Establishment Types
Manufacture Medical Device