| 510(k) Number |
K861415 |
| Device Name |
CANON AUTO REF KERATOMETER RK-1 |
| Applicant |
| Canon USA, Inc. |
| One Jericho Plaza |
|
Jericho,
NY
11753 -1000
|
|
| Applicant Contact |
TAMADA |
| Correspondent |
| Canon USA, Inc. |
| One Jericho Plaza |
|
Jericho,
NY
11753 -1000
|
|
| Correspondent Contact |
TAMADA |
| Date Received | 04/15/1986 |
| Decision Date | 05/14/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|