Device Classification Name |
Instrument, Ent Manual Surgical
|
510(k) Number |
K190525 |
Device Name |
RELIEVA ULTIRRA Sinus Balloon Catheter |
Applicant |
Acclarent, Inc. |
33 Technology Drive |
Irvine,
CA
92618
|
|
Applicant Contact |
Leena Sorathia |
Correspondent |
Acclarent, Inc. |
33 Technology Drive |
Irvine,
CA
92618
|
|
Correspondent Contact |
Leena Sorathia |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 03/04/2019 |
Decision Date | 05/03/2019 |
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
|
|
|