| Device Classification Name |
implant, eye valve
|
|---|
| 510(k) Number |
K885125 |
|---|
| Device Name |
KRUPIN EYE VALVE W/SCLERAL BUCKLE |
|---|
| Applicant |
| HOOD LABORATORIES |
| 575 WASHINGTON ST. |
|
PEMBROKE,
MA
02359
|
|
| Applicant Contact |
LEWIS H MARTEN |
| Correspondent |
| HOOD LABORATORIES |
| 575 WASHINGTON ST. |
|
PEMBROKE,
MA
02359
|
|
| Correspondent Contact |
LEWIS H MARTEN |
| Regulation Number | 886.3920
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 12/12/1988 |
|---|
| Decision Date | 01/24/1989 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Ophthalmic
|
|---|
| 510k Review Panel |
Ophthalmic
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|