510(k) K132423 ยท HEX Colposcope (And Colpomicroscope)
THE GYNOCULAR
| Applicant | Gynius AB, Stockholm, SE |
| Decision | Substantially Equivalent, Apr 8, 2014 |
| Received | Aug 5, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132423
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.