| Device Classification Name |
Photokeratoscope
|
| 510(k) Number |
K901523 |
| Device Name |
VKG 1000, VIDEO KERATOGRAPH |
| Applicant |
| The Sanborn Co. |
| 5181 Lafayette St. |
|
Santa Clara,
CA
95054
|
|
| Applicant Contact |
CARL R JORDAN |
| Correspondent |
| The Sanborn Co. |
| 5181 Lafayette St. |
|
Santa Clara,
CA
95054
|
|
| Correspondent Contact |
CARL R JORDAN |
| Regulation Number | 886.1350 |
| Classification Product Code |
|
| Date Received | 04/02/1990 |
| Decision Date | 06/27/1990 |
| 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
|
|
|