Device Classification Name |
Neurosurgical Nerve Locator
|
510(k) Number |
K201454 |
Device Name |
DSG Connect Technology |
Applicant |
SpineGuard, S.A. |
10 Cours Louis Lumiere |
Vincennes,
FR
94300
|
|
Applicant Contact |
Stephane Bette |
Correspondent |
Hogan Lovells US LLP |
555 Thirteenth Street NW |
Washington,
DC
20004
|
|
Correspondent Contact |
John Smith |
Regulation Number | 874.1820
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/01/2020 |
Decision Date | 02/10/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|