Device Classification Name |
Lens, Contact (Other Material) - Daily
|
510(k) Number |
K000133 |
Device Name |
MENICON Z |
Applicant |
MENICON U.S.A., INC. |
269 A BALLARDVALE ST. |
WILMINGTON,
MA
01887
|
|
Applicant Contact |
BEVERLY D VENUTI |
Correspondent |
MENICON U.S.A., INC. |
269 A BALLARDVALE ST. |
WILMINGTON,
MA
01887
|
|
Correspondent Contact |
BEVERLY D VENUTI |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 01/18/2000 |
Decision Date | 05/19/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|