Device Classification Name |
Ophthalmoscope, Ac-Powered
|
510(k) Number |
K841767 |
Device Name |
WOODLYN CLASSIC KERATOMETER |
Applicant |
WOODLYN, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
WOODLYN, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 04/27/1984 |
Decision Date | 08/07/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|