Device Classification Name |
stimulator, nerve
|
510(k) Number |
K031003 |
Device Name |
STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES |
Applicant |
MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216
|
|
Applicant Contact |
MARTIN D SARGENT |
Correspondent |
MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216
|
|
Correspondent Contact |
MARTIN D SARGENT |
Regulation Number | 874.1820
|
Classification Product Code |
|
Date Received | 03/31/2003 |
Decision Date | 04/11/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|