Device Classification Name |
Cannula, Sinus
|
510(k) Number |
K062458 |
Device Name |
ETHMOID SINUS SPACER |
Applicant |
ACCLARENT, INC. |
1525-B O'BRIEN DR. |
MENLO PARK,
CA
94025
|
|
Applicant Contact |
DEBBIE COGAN |
Correspondent |
ACCLARENT, INC. |
1525-B O'BRIEN DR. |
MENLO PARK,
CA
94025
|
|
Correspondent Contact |
DEBBIE COGAN |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 08/23/2006 |
Decision Date | 09/15/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|