Device Classification Name |
refractor, manual, non-powered, including phoropter
|
510(k) Number |
K874900 |
Device Name |
WOODLYN CLASSIC REFRACTOR, PHOROPTOR |
Applicant |
WOODLYN, INC. |
2920 MALMO DR. |
ARLINGTON HEIGHTS,
IL
60005 -4726
|
|
Applicant Contact |
RONAL NIELSEN |
Correspondent |
WOODLYN, INC. |
2920 MALMO DR. |
ARLINGTON HEIGHTS,
IL
60005 -4726
|
|
Correspondent Contact |
RONAL NIELSEN |
Regulation Number | 886.1770
|
Classification Product Code |
|
Date Received | 12/01/1987 |
Decision Date | 12/23/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|