Device Classification Name |
hearing aid, bone conduction
|
510(k) Number |
K110996 |
Device Name |
BAHA 3 POWER SOUND PROCESSOR |
Applicant |
COCHLEAR AMERICAS |
13059 E. PEAKVIEW AVE |
CENTENNIAL,
CO
80111
|
|
Applicant Contact |
SEAN BUNDY |
Correspondent |
COCHLEAR AMERICAS |
13059 E. PEAKVIEW AVE |
CENTENNIAL,
CO
80111
|
|
Correspondent Contact |
SEAN BUNDY |
Regulation Number | 874.3302
|
Classification Product Code |
|
Date Received | 04/11/2011 |
Decision Date | 05/10/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|