Device Classification Name |
keratoscope, battery-powered
|
510(k) Number |
K901553 |
Device Name |
SURG-K SURGICAL KERATOMETER |
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 | 04/03/1990 |
Decision Date | 07/20/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|