Device Classification Name |
accessories, soft lens products
|
510(k) Number |
K032030 |
FOIA Releasable 510(k) |
K032030
|
Device Name |
BLINK CL LUBRICANT EYE DROPS |
Applicant |
ADVANCED MEDICAL OPTICS, INC. |
1700 E. ST. ANDREW PLACE |
P.O. BOX 25162 |
SANTA ANA,
CA
92705 -4933
|
|
Applicant Contact |
PAUL J NOWACKI |
Correspondent |
ADVANCED MEDICAL OPTICS, INC. |
1700 E. ST. ANDREW PLACE |
P.O. BOX 25162 |
SANTA ANA,
CA
92705 -4933
|
|
Correspondent Contact |
PAUL J NOWACKI |
Regulation Number | 886.5928
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/01/2003 |
Decision Date | 09/25/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|