Device Classification Name |
lens, contact (other material) - daily
|
510(k) Number |
K102154 |
Device Name |
TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS |
Applicant |
THE LAGADO CORP. |
203 NORTH WABASH, |
STE 2208 |
CHICAGO,
IL
60601
|
|
Applicant Contact |
JOHN M SZABOCISK |
Correspondent |
THE LAGADO CORP. |
203 NORTH WABASH, |
STE 2208 |
CHICAGO,
IL
60601
|
|
Correspondent Contact |
JOHN M SZABOCISK |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 07/30/2010 |
Decision Date | 01/21/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|