The following data is part of a premarket notification filed by Amsel Medical Corporation with the FDA for Amsel Endo Occluder.
| Device ID | K180650 |
| 510k Number | K180650 |
| Device Name: | Amsel Endo Occluder |
| Classification | Clip, Implantable |
| Applicant | Amsel Medical Corporation 171 Hamilton Street Cambridge, MA 02139 |
| Contact | Yoram Levy |
| Correspondent | Leo L Basta Amsel Medical Corporation 171 Hamilton Street Cambridge, MA 02139 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-13 |
| Decision Date | 2018-11-15 |
| Summary: | summary |