Device Classification Name |
Lens, Contact (Other Material) - Daily
|
510(k) Number |
K963512 |
Device Name |
BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL |
Applicant |
BENZ RESEARCH AND DEVELOPMENT CORP. |
611 EISENHAUER ST. |
GRAND JUNCTION,
CO
81505
|
|
Applicant Contact |
MARTIN DALSING |
Correspondent |
BENZ RESEARCH AND DEVELOPMENT CORP. |
611 EISENHAUER ST. |
GRAND JUNCTION,
CO
81505
|
|
Correspondent Contact |
MARTIN DALSING |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 08/30/1996 |
Decision Date | 07/31/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|