Device Classification Name |
Eustachian Tube Balloon Dilation Device
|
510(k) Number |
K171761 |
Device Name |
ACCLARENT AERA Eustachian Tube Balloon Dilation System |
Applicant |
Acclarent, Inc. |
33 Technology Drive |
Irvine,
CA
92618
|
|
Applicant Contact |
James Patrick Garvey II |
Correspondent |
Acclarent, Inc. |
33 Technology Drive |
Irvine,
CA
92618
|
|
Correspondent Contact |
James Patrick Garvey II |
Regulation Number | 874.4180
|
Classification Product Code |
|
Date Received | 06/14/2017 |
Decision Date | 01/16/2018 |
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
|
|
|