Device Classification Name |
Prosthesis, Partial Ossicular Replacement
|
510(k) Number |
K972492 |
Device Name |
BELL PROSTHESIS (PARTIAL) |
Applicant |
HEINZ KURZ |
TUEBINGER STRASSE 3 |
DUSSLINGEN,
DE
D-72144
|
|
Applicant Contact |
DAGMAR S MASER |
Correspondent |
HEINZ KURZ |
TUEBINGER STRASSE 3 |
DUSSLINGEN,
DE
D-72144
|
|
Correspondent Contact |
DAGMAR S MASER |
Regulation Number | 874.3450
|
Classification Product Code |
|
Date Received | 07/02/1997 |
Decision Date | 08/04/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|