Device Classification Name |
lens, contact (other material) - daily
|
510(k) Number |
K180616 |
Device Name |
OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens |
Applicant |
Contamac Ltd. |
Carlton House Shire Hall |
Saffron Walden,
GB
CB11 3AU
|
|
Applicant Contact |
Rob McGregor |
Correspondent |
EyeReg Consulting, Inc. |
6119 Canter Ln |
West Linn,
OR
97068
|
|
Correspondent Contact |
Bret Andre |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 03/08/2018 |
Decision Date | 04/25/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|