| Device Classification Name |
Implant, Eye Valve
|
|---|
| 510(k) Number |
K903462 |
|---|
| Device Name |
OPTIMED GLAUCOMA PRESSURE REGULATOR |
|---|
| Applicant |
| OPTIMED, INC. |
| 126 POWER AVE. |
|
SANTA BARBARA,
CA
93103
|
|
| Applicant Contact |
MYRON LIPPMAN |
| Correspondent |
| OPTIMED, INC. |
| 126 POWER AVE. |
|
SANTA BARBARA,
CA
93103
|
|
| Correspondent Contact |
MYRON LIPPMAN |
| Regulation Number | 886.3920
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 08/01/1990 |
|---|
| Decision Date | 10/16/1990 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Ophthalmic
|
|---|
| 510k Review Panel |
Ophthalmic
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|