Device Classification Name |
lens, contact (other material) - daily
|
510(k) Number |
K081178 |
Device Name |
OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES |
Applicant |
CONTAMAC LTD. |
806 KIMBALL AVENUE |
GRAND JUNCTION,
CO
81501
|
|
Applicant Contact |
MARTIN DALSING |
Correspondent |
CONTAMAC LTD. |
806 KIMBALL AVENUE |
GRAND JUNCTION,
CO
81501
|
|
Correspondent Contact |
MARTIN DALSING |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 04/25/2008 |
Decision Date | 10/09/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|