Device Classification Name |
instrument, measuring, corneal radius
|
510(k) Number |
K864037 |
Device Name |
KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER |
Applicant |
KERA CORP. |
2362 WALSH AVE. |
SANTA CLARA,
CA
95051
|
|
Applicant Contact |
WILLIAM B COLLINS |
Correspondent |
KERA CORP. |
2362 WALSH AVE. |
SANTA CLARA,
CA
95051
|
|
Correspondent Contact |
WILLIAM B COLLINS |
Regulation Number | 886.1450
|
Classification Product Code |
|
Date Received | 10/16/1986 |
Decision Date | 11/13/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|