Device Classification Name |
Lens, Contact (Other Material) - Daily
|
510(k) Number |
K170335 |
Device Name |
Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens |
Applicant |
Valley Contax, Inc. |
200 S Mill St |
Springfield,
OR
97477
|
|
Applicant Contact |
Josh Adams |
Correspondent |
EyeReg Consulting, Inc. |
6119 Canter Ln. |
West Linn,
OR
97068
|
|
Correspondent Contact |
Bret Andre |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 02/02/2017 |
Decision Date | 03/24/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|