Device Classification Name |
instrument, ent manual surgical
|
510(k) Number |
K093007 |
Device Name |
ENTELLUS MEDICAL BALLOON DEVICE |
Applicant |
Entellus Medical, Inc. |
18555 37TH AVENUE NORTH |
PLYMOUTH,
MN
55446
|
|
Applicant Contact |
Sew-Wah Tay |
Correspondent |
Entellus Medical, Inc. |
18555 37TH AVENUE NORTH |
PLYMOUTH,
MN
55446
|
|
Correspondent Contact |
Sew-Wah Tay |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 09/28/2009 |
Decision Date | 02/05/2010 |
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
|
|
|