Device Classification Name |
Lenses, Soft Contact, Daily Wear
|
510(k) Number |
K024177 |
Device Name |
ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER |
Applicant |
JOHNSON & JOHNSON VISION CARE, INC. |
7500 CENTURION PKWY. |
SUITE 100 |
JACKSONVILLE,
FL
32256
|
|
Applicant Contact |
JAMES W PARZIALE |
Correspondent |
JOHNSON & JOHNSON VISION CARE, INC. |
7500 CENTURION PKWY. |
SUITE 100 |
JACKSONVILLE,
FL
32256
|
|
Correspondent Contact |
JAMES W PARZIALE |
Regulation Number | 886.5925
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/18/2002 |
Decision Date | 01/22/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|