Device Classification Name |
Lenses, Soft Contact, Daily Wear
|
510(k) Number |
K071736 |
Device Name |
AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS |
Applicant |
COOPERVISION, INC. |
6140 STONERIDGE MALL ROAD |
SUITE 500 |
PLEASANTON,
CA
94588
|
|
Applicant Contact |
JACK P DOUGLAS |
Correspondent |
COOPERVISION, INC. |
6140 STONERIDGE MALL ROAD |
SUITE 500 |
PLEASANTON,
CA
94588
|
|
Correspondent Contact |
JACK P DOUGLAS |
Regulation Number | 886.5925
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/26/2007 |
Decision Date | 01/04/2008 |
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
|
|
|