510(k) K110766 ยท HIB Speculum, Vaginal, Nonmetal
KOLPLUX SYSTEM
| Applicant | Kolplast CI Ltda, Crofton MD, US |
| Decision | Substantially Equivalent, Sep 15, 2011 |
| Received | Mar 18, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110766
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.