Device Classification Name |
Lenses, Soft Contact, Daily Wear
|
510(k) Number |
K121324 |
Device Name |
AVT NATURASOFT |
Applicant |
ADVANCED VISION TECHNOLOGIES |
806 KIMBALL AVE |
GRAND JUNCTION,
CO
81501
|
|
Applicant Contact |
MARTIN DALSING |
Correspondent |
ADVANCED VISION TECHNOLOGIES |
806 KIMBALL AVE |
GRAND JUNCTION,
CO
81501
|
|
Correspondent Contact |
MARTIN DALSING |
Regulation Number | 886.5925
|
Classification Product Code |
|
Date Received | 05/02/2012 |
Decision Date | 08/23/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|