The following data is part of a premarket notification filed by Endomagnetics Ltd with the FDA for Magseed Magnetic Marker System.
| Device ID | K163541 |
| 510k Number | K163541 |
| Device Name: | Magseed Magnetic Marker System |
| Classification | Temporary Tissue Marker |
| 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 | PBY |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-16 |
| Decision Date | 2017-01-13 |
| Summary: | summary |