Device Classification Name |
Hearing Aid, Bone Conduction
|
510(k) Number |
K100360 |
Device Name |
BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT |
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 | 02/12/2010 |
Decision Date | 07/13/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|