Device Classification Name |
instrument, ent manual surgical
|
510(k) Number |
K061903 |
Device Name |
RELIEVA SINUS BALLOON CATHETER |
Applicant |
ACCLARENT, INC. |
1525-B O'BRIEN DR. |
MENLO PARK,
CA
94025
|
|
Applicant Contact |
KERI YEN |
Correspondent |
ACCLARENT, INC. |
1525-B O'BRIEN DR. |
MENLO PARK,
CA
94025
|
|
Correspondent Contact |
KERI YEN |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 07/05/2006 |
Decision Date | 08/18/2006 |
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
|
|
|