510(k) K073095 ยท NEU Marker, Radiographic, Implantable
TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560
| Applicant | Somatex Medical Technologies GmbH, Cambridge MA, US |
| Decision | Substantially Equivalent, Mar 19, 2008 |
| Received | Nov 1, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073095
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2017 | Somatex Medical Technologies GmbH TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE Terminated |
NEU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.