Device Classification Name |
Accessories, Soft Lens Products
|
510(k) Number |
K981168 |
Device Name |
COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND 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 | 04/01/1998 |
Decision Date | 09/01/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|