Device Classification Name |
keratome, ac-powered
|
510(k) Number |
K031735 |
Device Name |
CENTURION SES EPIKERATOME |
Applicant |
CIBA VISION CORPORATION |
11460 JOHNS CREEK PKWY. |
DULUTH,
GA
30097
|
|
Applicant Contact |
PENNY NORTHCUTT |
Correspondent |
CIBA VISION CORPORATION |
11460 JOHNS CREEK PKWY. |
DULUTH,
GA
30097
|
|
Correspondent Contact |
PENNY NORTHCUTT |
Regulation Number | 886.4370
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/04/2003 |
Decision Date | 08/21/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|