Device Classification Name |
Accessories, Soft Lens Products
|
510(k) Number |
K083812 |
Device Name |
REFRESH OPTIVE LENS COMFORT REWETTING DROPS |
Applicant |
ALLERGAN, INC. |
269A BALLARDVALE STREET |
WILMINGTON,
MA
01887
|
|
Applicant Contact |
BEVERLEY D VENUTI |
Correspondent |
ALLERGAN, INC. |
269A BALLARDVALE STREET |
WILMINGTON,
MA
01887
|
|
Correspondent Contact |
BEVERLEY D VENUTI |
Regulation Number | 886.5928
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/22/2008 |
Decision Date | 07/09/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00691197
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|