Device Classification Name |
prosthesis, partial ossicular replacement
|
510(k) Number |
K913619 |
Device Name |
CERAVITAL MIDDLE EAR IMPLANT |
Applicant |
FRIEDRICHSFELD MEDIZINTECHNIK AG |
47 QUAIL COURT |
SUITE 301 |
WALNUT CREEK,
CA
94596
|
|
Applicant Contact |
JAMES P STOUT |
Correspondent |
FRIEDRICHSFELD MEDIZINTECHNIK AG |
47 QUAIL COURT |
SUITE 301 |
WALNUT CREEK,
CA
94596
|
|
Correspondent Contact |
JAMES P STOUT |
Regulation Number | 874.3450
|
Classification Product Code |
|
Date Received | 08/13/1991 |
Decision Date | 10/15/1991 |
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
|
|
|