Device Classification Name |
Hearing Aid, Bone Conduction
|
510(k) Number |
K021837 |
Device Name |
BRANENMARK BONE-ANCHORED-HEARING AID (BAHA) |
Applicant |
ENTIFIC MEDICAL SYSTEMS, INC. |
6470 RIVERVIEW TERRACE |
MINNEAPOLIS,
MN
55432
|
|
Applicant Contact |
CONSTANCE BUNDY |
Correspondent |
ENTIFIC MEDICAL SYSTEMS, INC. |
6470 RIVERVIEW TERRACE |
MINNEAPOLIS,
MN
55432
|
|
Correspondent Contact |
CONSTANCE BUNDY |
Regulation Number | 874.3302
|
Classification Product Code |
|
Date Received | 06/04/2002 |
Decision Date | 08/30/2002 |
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
|
|
|