Device Classification Name |
Lens, Contact (Other Material) - Daily
|
510(k) Number |
K033599 |
Device Name |
ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS |
Applicant |
THE LAGADO CORP. |
203 NORTH WABASH AVENUE |
SUITE 1200 |
CHICAGO,
IL
60601
|
|
Applicant Contact |
JOHN M SZABOCSIK |
Correspondent |
THE LAGADO CORP. |
203 NORTH WABASH AVENUE |
SUITE 1200 |
CHICAGO,
IL
60601
|
|
Correspondent Contact |
JOHN M SZABOCSIK |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 11/14/2003 |
Decision Date | 09/16/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|