Device Classification Name |
Instrument, Ent Manual Surgical
|
510(k) Number |
K132297 |
Device Name |
EM SINUS DILATION SYSTEM |
Applicant |
MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216
|
|
Applicant Contact |
ROZANNE PACIEJ |
Correspondent |
MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216
|
|
Correspondent Contact |
ROZANNE PACIEJ |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 07/24/2013 |
Decision Date | 11/05/2013 |
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
|
|
|