Device Classification Name |
lens, contact (other material) - daily
|
510(k) Number |
K962006 |
Device Name |
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS |
Applicant |
MENICON CO. LTD. |
700 THIRTEENTH STREET, N.W., |
SUITE 1200 |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
A. WES SIEGNER,, JR. |
Correspondent |
MENICON CO. LTD. |
700 THIRTEENTH STREET, N.W., |
SUITE 1200 |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
A. WES SIEGNER,, JR. |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 05/22/1996 |
Decision Date | 10/09/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|