| Device Classification Name |
Keratoprosthesis, Permanent Implant
|
|---|
| 510(k) Number |
K013756 |
|---|
| Device Name |
ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) |
|---|
| Applicant |
| Argus Biomedical Pty, Ltd. |
| 3307 Clifton Ave. |
|
Cincinnati,
OH
45220
|
|
| Applicant Contact |
BARBARA S FANT |
| Correspondent |
| Argus Biomedical Pty, Ltd. |
| 3307 Clifton Ave. |
|
Cincinnati,
OH
45220
|
|
| Correspondent Contact |
BARBARA S FANT |
| Regulation Number | 886.3400 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 11/13/2001 |
|---|
| Decision Date | 08/29/2002 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Ophthalmic
|
|---|
| 510k Review Panel |
Ophthalmic
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|