Device Classification Name |
lenses, soft contact, daily wear
|
510(k) Number |
K042275 |
Device Name |
VISTAKON (SENOFILCON A) SOFT CONTACT LENS |
Applicant |
VISTAKON |
3012 ST. CHARLES DR. |
TAMPA,
FL
33618
|
|
Applicant Contact |
ANNETTE M HILLRING |
Correspondent |
VISTAKON |
3012 ST. CHARLES DR. |
TAMPA,
FL
33618
|
|
Correspondent Contact |
ANNETTE M HILLRING |
Regulation Number | 886.5925
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/23/2004 |
Decision Date | 10/28/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|