Device Classification Name |
set, lens, trial, ophthalmic
|
510(k) Number |
K900478 |
Device Name |
WOODLYN FULL APERTURE TRIAL LENS SET |
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 | 886.1405
|
Classification Product Code |
|
Date Received | 02/01/1990 |
Decision Date | 02/21/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|