| Device Classification Name |
Accessories, Soft Lens Products
|
| 510(k) Number |
K060924 |
| Device Name |
JSZ MULTIACTION GP CONTACT LENS SOLUTION |
| Applicant |
| Szabocsik and Associates |
| 203 N. Wabash Ave. |
| Suite 1200 |
|
Chicago,
IL
60601
|
|
| Applicant Contact |
JOHN M SZABOCSIK |
| Correspondent |
| Szabocsik and Associates |
| 203 N. Wabash Ave. |
| Suite 1200 |
|
Chicago,
IL
60601
|
|
| Correspondent Contact |
JOHN M SZABOCSIK |
| Regulation Number | 886.5928 |
| Classification Product Code |
|
| Subsequent Product Code |
|
| Date Received | 04/04/2006 |
| Decision Date | 06/28/2006 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Ophthalmic
|
| 510k Review Panel |
Ophthalmic
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|