Device Classification Name |
Cannula, Sinus
|
510(k) Number |
K973273 |
Device Name |
XOMED T-STENT, FRONTAL SINUS STENT |
Applicant |
XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216 -0980
|
|
Applicant Contact |
DEBRA B CORTNER |
Correspondent |
XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216 -0980
|
|
Correspondent Contact |
DEBRA B CORTNER |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 09/02/1997 |
Decision Date | 09/29/1997 |
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
|
|
|