Device Classification Name |
lenses, soft contact, daily wear
|
510(k) Number |
K113245 |
Device Name |
AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL |
Applicant |
COOPERVISION, INC. |
6150 Stoneridge Mall Road |
Suite 370 |
Pleasanton,
CA
94588
|
|
Applicant Contact |
GWEN SHARP |
Correspondent |
COOPERVISION, INC. |
6150 Stoneridge Mall Road |
Suite 370 |
Pleasanton,
CA
94588
|
|
Correspondent Contact |
GWEN SHARP |
Regulation Number | 886.5925
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/02/2011 |
Decision Date | 12/02/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|