Device Classification Name |
Prosthesis, Partial Ossicular Replacement
|
510(k) Number |
K893134 |
Device Name |
APACERAM OSSICULAR PROSTHESIS |
Applicant |
ASAHI OPTICAL CO. C/O ROSATI ASSOCIATES, P.C. |
ATTORNEY & COUNSELOR AT LAW |
31815 SOUTHFIELD ROAD - #15 |
BIRMINGHAM,
MI
48009
|
|
Applicant Contact |
SAMUEL C URSU |
Correspondent |
ASAHI OPTICAL CO. C/O ROSATI ASSOCIATES, P.C. |
ATTORNEY & COUNSELOR AT LAW |
31815 SOUTHFIELD ROAD - #15 |
BIRMINGHAM,
MI
48009
|
|
Correspondent Contact |
SAMUEL C URSU |
Regulation Number | 874.3450
|
Classification Product Code |
|
Date Received | 04/25/1989 |
Decision Date | 08/03/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|