Device Classification Name |
Eustachian Tube Balloon Dilation Device
|
510(k) Number |
K220027 |
Device Name |
Audion ET dilation system |
Applicant |
Entellus Medical, Inc. |
3600 Holly Lane North, Suite 40 |
Plymouth,
MN
55447
|
|
Applicant Contact |
Katie Wilson |
Correspondent |
Entellus Medical, Inc. |
3600 Holly Lane North, Suite 40 |
Plymouth,
MN
55447
|
|
Correspondent Contact |
Katie Wilson |
Regulation Number | 874.4180
|
Classification Product Code |
|
Date Received | 01/05/2022 |
Decision Date | 04/12/2022 |
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
|
|
|