The following data is part of a premarket notification filed by Amsel Medical Corporation with the FDA for Amsel Occluder Device.
| Device ID | K140932 |
| 510k Number | K140932 |
| Device Name: | AMSEL OCCLUDER DEVICE |
| Classification | Clip, Implantable |
| Applicant | AMSEL MEDICAL CORPORATION 93 BENEFIT STREET Providence, RI 02904 |
| Contact | Leo Basta |
| Correspondent | Leo Basta AMSEL MEDICAL CORPORATION 93 BENEFIT STREET Providence, RI 02904 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-11 |
| Decision Date | 2015-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857774006000 | K140932 | 000 |