The following data is part of a premarket notification filed by Somatex Medical Technologies Gmbh with the FDA for Tumark For Eviva, Tumark For Brevera.
| Device ID | K182082 |
| 510k Number | K182082 |
| Device Name: | Tumark For Eviva, Tumark For Brevera |
| Classification | Marker, Radiographic, Implantable |
| Applicant | Somatex Medical Technologies GmbH Rheinstrasse 7d Teltow, DE 14513 |
| Contact | Burkhard Jakob |
| Correspondent | Burkhard Jakob Somatex Medical Technologies GmbH Rheinstrasse 7d Teltow, DE 14513 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-02 |
| Decision Date | 2018-10-31 |
| Summary: | summary |