Device Classification Name |
instrument, ent manual surgical
|
510(k) Number |
K133016 |
Device Name |
VENT-OS SINUS DILATION SYSTEM |
Applicant |
SINUSYS CORPORATION |
8 SNOWBERRY COURT |
ORINDA,
CA
94563
|
|
Applicant Contact |
MICHAELE A DANIEL |
Correspondent |
SINUSYS CORPORATION |
8 SNOWBERRY COURT |
ORINDA,
CA
94563
|
|
Correspondent Contact |
MICHAELE A DANIEL |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 09/25/2013 |
Decision Date | 12/09/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01623050
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|