The following data is part of a premarket notification filed by Endomagnetics Ltd. with the FDA for Magseed Magnetic Marker Systtem.
| Device ID | K173587 |
| 510k Number | K173587 |
| Device Name: | Magseed Magnetic Marker Systtem |
| Classification | Marker, Radiographic, Implantable |
| Applicant | Endomagnetics Ltd. The Jeffreys Building, Cowley Road Cambridge, GB Cb4 0ws |
| Contact | Andrew Shawcross |
| Correspondent | Andrew Shawcross Endomagnetics Ltd. The Jeffreys Building, Cowley Road Cambridge, GB Cb4 0ws |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-20 |
| Decision Date | 2018-02-16 |
| Summary: | summary |