510(k) K895013
- Device
- COBO TEMPORARY KERATOPROSTHESIS
- Applicant
- OCULAR INSTRUMENTS, INC.
- 510(k) number
- K895013
- Product code
- MLP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-31
- Date received
- 1989-08-08
- 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
- TAMSIN J ERICKSON
- Address
- 2255 116th Ave., NE Bellevue WA US 98004 98004
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 |
| K842856 | LANDERS-FOULKS TEMP. KERATOPROSTHESIS | Ocular Instruments, Inc. | 1984-12-18 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases