K093064 is an FDA 510(k) clearance for the TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560. This device is classified as a Marker, Radiographic, Implantable (Class II - Special Controls, product code NEU).
Submitted by Somatex Medical Technologies GmbH (Cambridge, US). The FDA issued a Cleared decision on February 17, 2010, 140 days after receiving the submission on September 30, 2009.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K093064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2009 |
| Decision Date | February 17, 2010 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEU - Marker, Radiographic, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |