Device Classification Name |
stimulator, nerve
|
510(k) Number |
K140400 |
Device Name |
ES2 NEUROMONITORING ACCESSORY INSTRUMENTS |
Applicant |
STRYKER CORPORATION |
2 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Applicant Contact |
SORAYA KING |
Correspondent |
STRYKER CORPORATION |
2 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Correspondent Contact |
SORAYA KING |
Regulation Number | 874.1820
|
Classification Product Code |
|
Date Received | 02/18/2014 |
Decision Date | 07/01/2014 |
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
|
|
|