Device Classification Name |
Accessories, Soft Lens Products
|
510(k) Number |
K003345 |
Device Name |
AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION |
Applicant |
CIBA VISION CORPORATION |
11460 JOHNS CREEK PKWY. |
DULUTH,
GA
30097
|
|
Applicant Contact |
STEVEN DOWDLEY |
Correspondent |
CIBA VISION CORPORATION |
11460 JOHNS CREEK PKWY. |
DULUTH,
GA
30097
|
|
Correspondent Contact |
STEVEN DOWDLEY |
Regulation Number | 886.5928
|
Classification Product Code |
|
Date Received | 10/25/2000 |
Decision Date | 03/26/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|