Device Classification Name |
Prosthesis, Partial Ossicular Replacement
|
510(k) Number |
K002897 |
Device Name |
TITANIUM MIDDLE EAR PROSTHESES |
Applicant |
XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216 -0980
|
|
Applicant Contact |
DAVID TIMLIN |
Correspondent |
XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216 -0980
|
|
Correspondent Contact |
DAVID TIMLIN |
Regulation Number | 874.3450
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/18/2000 |
Decision Date | 10/11/2000 |
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
|
Recalls |
CDRH Recalls
|
|
|