Device Classification Name |
Hearing Aid, Bone Conduction
|
510(k) Number |
K081606 |
Device Name |
BAHA INTENSO |
Applicant |
COCHLEAR AMERICAS |
400 INVERNESS PARKWAY, |
SUITE 400 |
ENGLEWOOD,
CO
80112
|
|
Applicant Contact |
SEAN BUNDY |
Correspondent |
COCHLEAR AMERICAS |
400 INVERNESS PARKWAY, |
SUITE 400 |
ENGLEWOOD,
CO
80112
|
|
Correspondent Contact |
SEAN BUNDY |
Regulation Number | 874.3302
|
Classification Product Code |
|
Date Received | 06/06/2008 |
Decision Date | 08/28/2008 |
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
|
|
|