510(k) K842856
- Device
- LANDERS-FOULKS TEMP. KERATOPROSTHESIS
- Applicant
- OCULAR INSTRUMENTS, INC.
- 510(k) number
- K842856
- Product code
- MLP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-12-18
- Date received
- 1984-07-20
- Regulation
- 886.3400
- Classification name
- Keratoprosthesis, Temporary Implant, Surgical Use
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES P ERICKSON
- Address
- 12100 Northup Way Suite D Bellevue WA US 98005 98005
FDA Registration Numbers#
- 3014865
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MLP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K910828 | LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS | Ocular Instruments, Inc. | 1991-08-21 |
| K902491 | ECKHARDT TEMPORARY KERATOPROSTHESIS | Dutch Ophthalmic USA, Inc. | 1990-06-26 |
| K895013 | COBO TEMPORARY KERATOPROSTHESIS | Ocular Instruments, Inc. | 1989-10-31 |
Legacy Summary#
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FDA Review#
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