Device Classification Name |
lenses, soft contact, daily wear
|
510(k) Number |
K050717 |
Device Name |
PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC |
Applicant |
COOPERVISION, INC. |
711 NORTH RD. |
SCOTTSVILLE,
NY
14546
|
|
Applicant Contact |
BONNIE TSYMBAL |
Correspondent |
COOPERVISION, INC. |
711 NORTH RD. |
SCOTTSVILLE,
NY
14546
|
|
Correspondent Contact |
BONNIE TSYMBAL |
Regulation Number | 886.5925
|
Classification Product Code |
|
Date Received | 03/21/2005 |
Decision Date | 05/13/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|