Device Classification Name |
keratoprosthesis, permanent implant
|
510(k) Number |
K915062 |
Device Name |
DOHLMAN DOANE KERATOPROTHESIS |
Applicant |
MACKEEN CONSULTANTS, LTD. |
4903 SANGAMORE RD. |
BETHESDA,
MD
20816
|
|
Applicant Contact |
DONALD L.MACKEEN |
Correspondent |
MACKEEN CONSULTANTS, LTD. |
4903 SANGAMORE RD. |
BETHESDA,
MD
20816
|
|
Correspondent Contact |
DONALD L.MACKEEN |
Regulation Number | 886.3400
|
Classification Product Code |
|
Date Received | 11/08/1991 |
Decision Date | 01/21/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|