510(k) K160380 ยท HEX Colposcope (And Colpomicroscope)
LT-300 HD
| Applicant | Lutech Industries, Inc., Ronkonkoma NY, US |
| Decision | Substantially Equivalent, May 13, 2016 |
| Received | Feb 10, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160380
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.