Device Classification Name |
lens, contact, polymethylmethacrylate, diagnostic
|
510(k) Number |
K173944 |
Device Name |
Endocular Viewing Lenses and Silicone Ring |
Applicant |
Phakos |
62 Rue Kleber |
Montreuil,
FR
93100
|
|
Applicant Contact |
J. D. Webb |
Correspondent |
The OrthoMedix Group, Inc. |
1001 Oakwood Blvd |
Round Rock,
TX
78681
|
|
Correspondent Contact |
J. D. Webb |
Regulation Number | 886.1385
|
Classification Product Code |
|
Date Received | 12/26/2017 |
Decision Date | 10/25/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|