| Device Classification Name |
Lens, Contact (Other Material) - Daily
|
|---|
| 510(k) Number |
K943784 |
|---|
| Device Name |
MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR |
|---|
| Applicant |
| Menicon Co, Ltd. |
| 700 Thirteenth St. N.W |
| Suite 1200 |
|
Washington,
DC
20005
|
|
| Applicant Contact |
A. WES SIEGNER |
| Correspondent |
| Menicon Co, Ltd. |
| 700 Thirteenth St. N.W |
| Suite 1200 |
|
Washington,
DC
20005
|
|
| Correspondent Contact |
A. WES SIEGNER |
| Regulation Number | 886.5916 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 07/26/1994 |
|---|
| Decision Date | 10/20/1994 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Ophthalmic
|
|---|
| 510k Review Panel |
Ophthalmic
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|