Device Classification Name |
hearing aid, bone conduction
|
510(k) Number |
K011438 |
Device Name |
BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. |
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 | 05/10/2001 |
Decision Date | 07/23/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|