Device Classification Name |
instrument, ent manual surgical
|
510(k) Number |
K152121 |
Device Name |
NuVent EM Sinus Dilation System |
Applicant |
MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DRIVE NORTH |
JACKSONVILLE,
FL
32216
|
|
Applicant Contact |
Gabriela Anchondo |
Correspondent |
MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DRIVE NORTH |
JACKSONVILLE,
FL
32216
|
|
Correspondent Contact |
Gabriela Anchondo |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 07/30/2015 |
Decision Date | 12/01/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02284347
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|