Device Classification Name |
lenses, soft contact, daily wear
|
510(k) Number |
K191763 |
Device Name |
MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC |
Applicant |
CooperVision, Inc. |
5870 Stoneridge Drive, Suite 1 |
Pleasanton,
CA
94588
|
|
Applicant Contact |
Marie Dutton |
Correspondent |
CooperVision, Inc. |
5870 Stoneridge Drive, Suite 1 |
Pleasanton,
CA
94588
|
|
Correspondent Contact |
Marie Dutton |
Regulation Number | 886.5925
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/01/2019 |
Decision Date | 03/23/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|