Device Classification Name |
Instrument, Ent Manual Surgical
|
510(k) Number |
K161698 |
Device Name |
Relieva UltirraNav Sinus Balloon Catheter |
Applicant |
ACCLARENT, INC. |
33 TECHNOLOGY DRIVE |
IRVINE,
CA
92618
|
|
Applicant Contact |
JAMES PATRICK GARVEY |
Correspondent |
ACCLARENT, INC. |
33 TECHNOLOGY DRIVE |
IRVINE,
CA
92618
|
|
Correspondent Contact |
JAMES PATRICK GARVEY |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 06/20/2016 |
Decision Date | 10/24/2016 |
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
|
|
|