Device Classification Name |
prosthesis, ear, internal
|
510(k) Number |
K844960 |
Device Name |
CANAL WALL PROSTHESIS |
Applicant |
RICHARDS MEDICAL CO., INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Applicant Contact |
ROBERT F GAMES |
Correspondent |
RICHARDS MEDICAL CO., INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Correspondent Contact |
ROBERT F GAMES |
Regulation Number | 878.3590
|
Classification Product Code |
|
Date Received | 12/21/1984 |
Decision Date | 02/26/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|