Device Classification Name |
hearing aid, bone conduction, implanted
|
510(k) Number |
K984162 |
Device Name |
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE |
Applicant |
NOBELPHARMA USA, INC. |
777 OAKMONT LN. |
SUITE 100 |
WESTMONT,
IL
60559
|
|
Applicant Contact |
BETSY A BROWN |
Correspondent |
NOBELPHARMA USA, INC. |
777 OAKMONT LN. |
SUITE 100 |
WESTMONT,
IL
60559
|
|
Correspondent Contact |
BETSY A BROWN |
Regulation Number | 874.3302
|
Classification Product Code |
|
Date Received | 11/19/1998 |
Decision Date | 06/28/1999 |
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
|
|
|