Device Classification Name |
lens, contact (other material) - daily
|
510(k) Number |
K171575 |
Device Name |
ENFLU 18 (enflufocon A) Daily Wear Contact Lens |
Applicant |
CONTAMAC Ltd. |
Carlton House Shire Hill |
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 | 05/30/2017 |
Decision Date | 10/24/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|