| Device Classification Name |
Implant, Eye Valve
|
|---|
| 510(k) Number |
K890598 |
|---|
| Device Name |
MOLTENO IMPLANT |
|---|
| Applicant |
| IOP, INC. |
| 22653 PACIFIC COAST HWY |
| SUITE 340 |
|
MALIBU,
CA
90265
|
|
| Applicant Contact |
JASON MALECKA |
| Correspondent |
| IOP, INC. |
| 22653 PACIFIC COAST HWY |
| SUITE 340 |
|
MALIBU,
CA
90265
|
|
| Correspondent Contact |
JASON MALECKA |
| Regulation Number | 886.3920
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 02/06/1989 |
|---|
| Decision Date | 02/27/1989 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Ophthalmic
|
|---|
| 510k Review Panel |
Ophthalmic
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|