Device Classification Name |
Prosthesis, Partial Ossicular Replacement
|
510(k) Number |
K861369 |
Device Name |
INCUS/STAPES PROSTHESIS |
Applicant |
RICHARDS MEDICAL CO., INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Applicant Contact |
ROBERTS F GAMES |
Correspondent |
RICHARDS MEDICAL CO., INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Correspondent Contact |
ROBERTS F GAMES |
Regulation Number | 874.3450
|
Classification Product Code |
|
Date Received | 04/11/1986 |
Decision Date | 07/14/1986 |
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
|
|
|