Device Classification Name |
clip, implantable
|
510(k) Number |
K180650 |
Device Name |
Amsel Endo Occluder |
Applicant |
Amsel Medical Corporation |
171 Hamilton Street |
Cambridge,
MA
02139
|
|
Applicant Contact |
Yoram Levy |
Correspondent |
Amsel Medical Corporation |
171 Hamilton Street |
Cambridge,
MA
02139
|
|
Correspondent Contact |
Leo L Basta |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 03/13/2018 |
Decision Date | 11/15/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|