Device Classification Name |
hearing aid, bone conduction, implanted
|
510(k) Number |
K150555 |
Device Name |
BA400 14mm Abutment |
Applicant |
COCHLEAR AMERICAS |
13059 E PEAKVIEW AVE |
CENTENNIAL,
CO
80111
|
|
Applicant Contact |
Tristan Manus |
Correspondent |
COCHLEAR AMERICAS |
13059 E PEAKVIEW AVE |
CENTENNIAL,
CO
80111
|
|
Correspondent Contact |
Tristan Manus |
Regulation Number | 874.3302
|
Classification Product Code |
|
Date Received | 03/04/2015 |
Decision Date | 07/15/2015 |
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
|
|
|