The following data is part of a premarket notification filed by Somatex Medical Technologies Gmbh with the FDA for Tumark Flex For Mammotome,tumark Flex For Atec.
| Device ID | K111692 |
| 510k Number | K111692 |
| Device Name: | TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC |
| Classification | Marker, Radiographic, Implantable |
| Applicant | SOMATEX MEDICAL TECHNOLOGIES GMBH UNTERER WINKEL 3 Wurmlingen, DE 78573 |
| Contact | Harald Jung |
| Correspondent | Harald Jung SOMATEX MEDICAL TECHNOLOGIES GMBH UNTERER WINKEL 3 Wurmlingen, DE 78573 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-16 |
| Decision Date | 2011-11-08 |
| Summary: | summary |