Device Classification Name |
lenses, soft contact, daily wear
|
510(k) Number |
K041138 |
Device Name |
LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS |
Applicant |
COOPERVISION, INC. |
711 NORTH RD. |
SCOTTSVILLE,
NY
14546
|
|
Applicant Contact |
BONNIE J TSYMBAL |
Correspondent |
COOPERVISION, INC. |
711 NORTH RD. |
SCOTTSVILLE,
NY
14546
|
|
Correspondent Contact |
BONNIE J TSYMBAL |
Regulation Number | 886.5925
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/30/2004 |
Decision Date | 07/23/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|