Device Classification Name |
prosthesis, partial ossicular replacement
|
510(k) Number |
K950984 |
Device Name |
HAPES MALLEABLE INCUS STAPES |
Applicant |
SMITH & NEPHEW RICHARDS, INC. |
2925 APPLING RD. |
BARTLETT,
TN
38133
|
|
Applicant Contact |
DEBORAH A ARTHUR |
Correspondent |
SMITH & NEPHEW RICHARDS, INC. |
2925 APPLING RD. |
BARTLETT,
TN
38133
|
|
Correspondent Contact |
DEBORAH A ARTHUR |
Regulation Number | 874.3450
|
Classification Product Code |
|
Date Received | 03/03/1995 |
Decision Date | 03/15/1995 |
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
|
|
|