Device Classification Name |
Ophthalmoscope, Ac-Powered
|
510(k) Number |
K843812 |
Device Name |
WOODLYN CLASSIC CATARACT ACUITY TEST |
Applicant |
WOODLYN, INC. |
2920 MALMO DR. |
ARLINGTON HEIGHTS,
IL
60005 -4726
|
|
Applicant Contact |
RONALD NIELSEN |
Correspondent |
WOODLYN, INC. |
2920 MALMO DR. |
ARLINGTON HEIGHTS,
IL
60005 -4726
|
|
Correspondent Contact |
RONALD NIELSEN |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 09/28/1984 |
Decision Date | 12/11/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|