Device Classification Name |
accessories, soft lens products
|
510(k) Number |
K992028 |
Device Name |
REFRESH CONTACTS LUBRICATING AND REWETTING DROPS |
Applicant |
ALLERGAN, INC. |
2525 DUPONT DR. |
P.O. BOX 19534 |
IRVINE,
CA
92623 -9534
|
|
Applicant Contact |
PAUL J NOWACKI |
Correspondent |
ALLERGAN, INC. |
2525 DUPONT DR. |
P.O. BOX 19534 |
IRVINE,
CA
92623 -9534
|
|
Correspondent Contact |
PAUL J NOWACKI |
Regulation Number | 886.5928
|
Classification Product Code |
|
Date Received | 06/16/1999 |
Decision Date | 10/07/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|