The following data is part of a premarket notification filed by Somatex Medical Technologies Gmbh with the FDA for Tumark Professional, Model 271560; Mr- Tumark Professional, Model 601560.
| Device ID | K073095 |
| 510k Number | K073095 |
| Device Name: | TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 |
| Classification | Marker, Radiographic, Implantable |
| Applicant | SOMATEX MEDICAL TECHNOLOGIES GMBH 1480 CAMBRIDGE STREET Cambridge, MA 02139 |
| Contact | Susanne Raab |
| Correspondent | Susanne Raab SOMATEX MEDICAL TECHNOLOGIES GMBH 1480 CAMBRIDGE STREET Cambridge, MA 02139 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-01 |
| Decision Date | 2008-03-19 |
| Summary: | summary |