Device Classification Name |
media, electroconductive
|
510(k) Number |
K161715 |
Device Name |
EndyGel |
Applicant |
EndyMed Medical Ltd. |
12 Leshem Street, North Industrial Park |
Caesarea,
IL
3088900
|
|
Applicant Contact |
Yoram Levy |
Correspondent |
Qsite |
31 Haavoda St. |
Binyamina,
IL
30500
|
|
Correspondent Contact |
Yoram Levy |
Regulation Number | 882.1275
|
Classification Product Code |
|
Date Received | 06/21/2016 |
Decision Date | 02/07/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|