Device Classification Name |
Instrument, Ent Manual Surgical
|
510(k) Number |
K140160 |
Device Name |
RELIEVA SCOUT SINUS DILATION SYSTEM |
Applicant |
ACCLARENT, INC. |
1525-B O'BRIEN DR. |
MENLO PARK,
CA
94025
|
|
Applicant Contact |
JAMES P GARVEY, II |
Correspondent |
ACCLARENT, INC. |
1525-B O'BRIEN DR. |
MENLO PARK,
CA
94025
|
|
Correspondent Contact |
JAMES P GARVEY, II |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 01/22/2014 |
Decision Date | 02/20/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|