Device Classification Name |
stimulator, nerve
|
510(k) Number |
K111671 |
Device Name |
SEASPINE MONOPOLAR PROBE SYSYEM |
Applicant |
SEASPINE, INC. |
2302 LA MIRADA DR. |
VISTA,
CA
92081 -7862
|
|
Applicant Contact |
DAN MILLER |
Correspondent |
SEASPINE, INC. |
2302 LA MIRADA DR. |
VISTA,
CA
92081 -7862
|
|
Correspondent Contact |
DAN MILLER |
Regulation Number | 874.1820
|
Classification Product Code |
|
Date Received | 06/15/2011 |
Decision Date | 12/28/2011 |
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
|
|
|