Device Classification Name |
Lens, Contact (Other Material) - Daily
|
510(k) Number |
K024164 |
Device Name |
COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT |
Applicant |
METRO OPTICS, INC. |
623 GLACIER DR. |
GRAND JUNCTION,
CO
81503
|
|
Applicant Contact |
DEANNA WERBER |
Correspondent |
METRO OPTICS, INC. |
623 GLACIER DR. |
GRAND JUNCTION,
CO
81503
|
|
Correspondent Contact |
DEANNA WERBER |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 12/17/2002 |
Decision Date | 02/12/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|