Device Classification Name |
case, contact lens
|
510(k) Number |
K112832 |
Device Name |
EYE CARE CURE CONTACT LENS CASE |
Applicant |
EYE CARE AND CURE |
4646 S OVERLAND DR |
TUCSON,
AZ
85714
|
|
Applicant Contact |
LINDY V DALEN |
Correspondent |
EYE CARE AND CURE |
4646 S OVERLAND DR |
TUCSON,
AZ
85714
|
|
Correspondent Contact |
LINDY V DALEN |
Regulation Number | 886.5928
|
Classification Product Code |
|
Date Received | 09/29/2011 |
Decision Date | 12/05/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|