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 | K093064 |
| 510k Number | K093064 |
| 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 | 2009-09-30 |
| Decision Date | 2010-02-17 |
| Summary: | summary |