Device Classification Name |
Stimulator, Nerve
|
510(k) Number |
K213246 |
Device Name |
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long |
Applicant |
Medtronic Xomed, Inc. |
6743 Southpoint Drive North |
Jacksonville,
FL
32216
|
|
Applicant Contact |
Alexandra Oliver |
Correspondent |
Medtronic Xomed, Inc. |
6743 Southpoint Drive North |
Jacksonville,
FL
32216
|
|
Correspondent Contact |
Alexandra Oliver |
Regulation Number | 874.1820
|
Classification Product Code |
|
Date Received | 09/30/2021 |
Decision Date | 03/21/2022 |
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
|
|
|