The following data is part of a premarket notification filed by Amsel Medical with the FDA for Amsel Occluder Device.
| Device ID | K172479 |
| 510k Number | K172479 |
| Device Name: | Amsel Occluder Device |
| Classification | Clip, Implantable |
| Applicant | Amsel Medical 171 Hamilton Street Cambridge, MA 02139 |
| Contact | Raanan Miller |
| Correspondent | Leo Basta Northstar Biomedical Associates 93 Benefit Street Providence, RI 02904 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-16 |
| Decision Date | 2017-09-14 |