Device Classification Name |
Lenses, Soft Contact, Daily Wear
|
510(k) Number |
K994318 |
Device Name |
VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER |
Applicant |
VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
7500 CENTURION PKWY. |
JACKSONVILLE,
FL
32256
|
|
Applicant Contact |
SHARON BRIGGS |
Correspondent |
VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
7500 CENTURION PKWY. |
JACKSONVILLE,
FL
32256
|
|
Correspondent Contact |
SHARON BRIGGS |
Regulation Number | 886.5925
|
Classification Product Code |
|
Date Received | 12/22/1999 |
Decision Date | 02/23/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|