Device Classification Name |
Stimulator, Nerve
|
510(k) Number |
K992869 |
Device Name |
XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE |
Applicant |
XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216 -0980
|
|
Applicant Contact |
MARTIN D SARGENT |
Correspondent |
XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216 -0980
|
|
Correspondent Contact |
MARTIN D SARGENT |
Regulation Number | 874.1820
|
Classification Product Code |
|
Date Received | 08/25/1999 |
Decision Date | 10/07/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|