The following data is part of a premarket notification filed by Endomagnetics Ltd. with the FDA for Sentimag System, Sentimark Magnetic Marker Systerm.
| Device ID | K153044 |
| 510k Number | K153044 |
| Device Name: | Sentimag System, Sentimark Magnetic Marker Systerm |
| Classification | Temporary Tissue Marker |
| Applicant | ENDOMAGNETICS LTD. THE JEFFREYS BUILDING, COWLEY ROAD Cambridge, GB Cb4 Ows |
| Contact | Andrew Shawcross |
| Correspondent | Andrew Shawcross ENDOMAGNETICS LTD. THE JEFFREYS BUILDING, COWLEY ROAD Cambridge, GB Cb4 Ows |
| Product Code | PBY |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-19 |
| Decision Date | 2016-03-02 |
| Summary: | summary |