Device Classification Name |
Lenses, Soft Contact, Daily Wear
|
510(k) Number |
K112373 |
Device Name |
CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION |
Applicant |
INNOVA VISION INC. |
2904 N. BOLDT DRIVE |
FLAGSTAFF,
AZ
86001
|
|
Applicant Contact |
JENNIFER REICH |
Correspondent |
INNOVA VISION INC. |
2904 N. BOLDT DRIVE |
FLAGSTAFF,
AZ
86001
|
|
Correspondent Contact |
JENNIFER REICH |
Regulation Number | 886.5925
|
Classification Product Code |
|
Date Received | 08/17/2011 |
Decision Date | 08/17/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|