Device Classification Name |
hearing aid, bone conduction, implanted
|
510(k) Number |
K182116 |
Device Name |
BA310 Abutment, BIA310 Implant/Abutment |
Applicant |
Cochlear Americas |
13059 E. Peakview Ave. |
Centennial,
CO
80111
|
|
Applicant Contact |
Beth Murray |
Correspondent |
Cochlear Americas |
13059 E. Peakview Ave. |
Centennial,
CO
80111
|
|
Correspondent Contact |
Beth Murray |
Regulation Number | 874.3302
|
Classification Product Code |
|
Date Received | 08/06/2018 |
Decision Date | 12/19/2018 |
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
|
|
|