Device Classification Name |
Lens, Contact, (Disposable)
|
510(k) Number |
K051900 |
Device Name |
ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR |
Applicant |
JOHNSON & JOHNSON VISION CARE, INC. |
7500 CENTURION PKWY. |
SUITE 100 |
JACKSONVILLE,
FL
32256
|
|
Applicant Contact |
SUSAN MORRIS |
Correspondent |
JOHNSON & JOHNSON VISION CARE, INC. |
7500 CENTURION PKWY. |
SUITE 100 |
JACKSONVILLE,
FL
32256
|
|
Correspondent Contact |
SUSAN MORRIS |
Regulation Number | 886.5925
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/13/2005 |
Decision Date | 08/12/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|