| 510(k) Number |
K854256 |
| Device Name |
KEELER AMOILS SURGICAL ASTIGOMETER |
| Applicant |
| Keeler Instruments, Inc. |
| 456 Pkwy. |
|
Broomall,
PA
19008
|
|
| Applicant Contact |
VAN ARSDAL |
| Correspondent |
| Keeler Instruments, Inc. |
| 456 Pkwy. |
|
Broomall,
PA
19008
|
|
| Correspondent Contact |
VAN ARSDAL |
| Date Received | 10/22/1985 |
| Decision Date | 12/13/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|