| 510(k) Number |
K792330 |
| Device Name |
XOMED MICROSURGERY BACKGROUND |
| Applicant |
| Xomed, Inc. |
| 1318 Lonedell Rd. |
|
Arnold,
MO
63010
|
|
| Correspondent |
| Xomed, Inc. |
| 1318 Lonedell Rd. |
|
Arnold,
MO
63010
|
|
| Date Received | 11/19/1979 |
| Decision Date | 12/06/1979 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|