Device Classification Name |
hearing aid, bone conduction
|
510(k) Number |
K992872 |
Device Name |
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II |
Applicant |
ENTIFIC MEDICAL SYSTEMS, INC. |
8944 TAMAROA TERRACE |
SKOKIE,
IL
60076
|
|
Applicant Contact |
BESTY A BROWN |
Correspondent |
ENTIFIC MEDICAL SYSTEMS, INC. |
8944 TAMAROA TERRACE |
SKOKIE,
IL
60076
|
|
Correspondent Contact |
BESTY A BROWN |
Regulation Number | 874.3302
|
Classification Product Code |
|
Date Received | 08/26/1999 |
Decision Date | 11/24/1999 |
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
|
|
|