Device Classification Name |
Accessories, Soft Lens Products
|
510(k) Number |
K190674 |
Device Name |
REFRESH RELIEVA For CONTACTS |
Applicant |
Allergan, Inc |
2525 Dupont Drive |
Irvine,
CA
92623 -9534
|
|
Applicant Contact |
Emily Huang |
Correspondent |
Allergan, Inc |
2525 Dupont Drive |
Irvine,
CA
92623 -9534
|
|
Correspondent Contact |
Emily Huang |
Regulation Number | 886.5928
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/15/2019 |
Decision Date | 08/08/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01844388
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|