Device Classification Name |
instrument, ent manual surgical
|
510(k) Number |
K120280 |
Device Name |
RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM |
Applicant |
ACCLARENT, INC. |
1525-B OBRIEN DR. |
MENLO PARK,
CA
94025
|
|
Applicant Contact |
DAN HARFE |
Correspondent |
ACCLARENT, INC. |
1525-B OBRIEN DR. |
MENLO PARK,
CA
94025
|
|
Correspondent Contact |
DAN HARFE |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 01/30/2012 |
Decision Date | 11/05/2012 |
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
|
|
|