Device Classification Name |
Keratoscope, Ac-Powered
|
510(k) Number |
K850665 |
Device Name |
CORNEASCOPE MODEL 1200 |
Applicant |
KERA CORP. |
2362 WALSH AVE. |
SANTA CLARA,
CA
95051
|
|
Applicant Contact |
COLLINS |
Correspondent |
KERA CORP. |
2362 WALSH AVE. |
SANTA CLARA,
CA
95051
|
|
Correspondent Contact |
COLLINS |
Regulation Number | 886.1350
|
Classification Product Code |
|
Date Received | 02/20/1985 |
Decision Date | 03/20/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|