Device Classification Name |
Prosthesis, Partial Ossicular Replacement
|
510(k) Number |
K910685 |
Device Name |
WEHRS INCUS AND INCUS-STAPES PROSTHESES |
Applicant |
SMITH & NEPHEW RICHARDS, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Applicant Contact |
ROBERT F GAMES |
Correspondent |
SMITH & NEPHEW RICHARDS, INC. |
1450 BROOKS RD. |
MEMPHIS,
TN
38116
|
|
Correspondent Contact |
ROBERT F GAMES |
Regulation Number | 874.3450
|
Classification Product Code |
|
Date Received | 02/19/1991 |
Decision Date | 12/04/1991 |
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
|
|
|