510(k) K143308 ยท HEW Culdoscope (And Accessories)
GelPOINT Transvaginal Access Platform
| Applicant | Applied Medical Resources, Rancho Santa CA, US |
| Decision | Substantially Equivalent, Oct 13, 2015 |
| Received | Nov 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143308
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.