Device Classification Name |
lens, contact, polymethylmethacrylate, diagnostic
|
510(k) Number |
K943125 |
Device Name |
QUADRASPHERIC FUNDUS LENS |
Applicant |
VOLK OPTICAL, INC. |
BOND COURT BUILDING |
1300 EAST NINTH ST., STE 900 |
CLEVELAND,
OH
44114
|
|
Applicant Contact |
JAMES A GOLDSMITH |
Correspondent |
VOLK OPTICAL, INC. |
BOND COURT BUILDING |
1300 EAST NINTH ST., STE 900 |
CLEVELAND,
OH
44114
|
|
Correspondent Contact |
JAMES A GOLDSMITH |
Regulation Number | 886.1385
|
Classification Product Code |
|
Date Received | 06/29/1994 |
Decision Date | 09/02/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|