Device Classification Name |
Hearing Aid, Bone Conduction, Implanted
|
510(k) Number |
K142678 |
Device Name |
Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm |
Applicant |
OTICON MEDICAL AB |
EKONOMIVAGEN 2 |
ASKIM,
SE
SE-436 33
|
|
Applicant Contact |
Carolina Anker Wessling |
Correspondent |
OTICON MEDICAL AB |
EKONOMIVAGEN 2 |
ASKIM,
SE
SE-436 33
|
|
Correspondent Contact |
Carolina Anker Wessling |
Regulation Number | 874.3302
|
Classification Product Code |
|
Date Received | 09/19/2014 |
Decision Date | 01/21/2015 |
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
|
|
|