Device Classification Name |
cannula, sinus
|
510(k) Number |
K813474 |
Device Name |
MAXILL-AIR SINUS VENTILATION TUBE |
Applicant |
XOMED, INC. |
1318 LONEDELL RD. |
ARNOLD,
MO
63010
|
|
Correspondent |
XOMED, INC. |
1318 LONEDELL RD. |
ARNOLD,
MO
63010
|
|
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 12/01/1981 |
Decision Date | 01/12/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|