Device Classification Name |
instrument, ent manual surgical
|
510(k) Number |
K171687 |
Device Name |
Relieva SpinPlus Nav Balloon Sinuplasty System |
Applicant |
Acclarent, Inc. |
33 Technology Drive |
Irvine,
CA
92618
|
|
Applicant Contact |
James Patrick Garvey II |
Correspondent |
Acclarent, Inc. |
33 Technology Drive |
Irvine,
CA
92618
|
|
Correspondent Contact |
James Patrick Garvey II |
Regulation Number | 874.4420
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/07/2017 |
Decision Date | 09/05/2017 |
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
|
|
|