510(k) K120743 ยท HIB Speculum, Vaginal, Nonmetal
SPECULUM, VAGINAL, NONMETAL
| Applicant | Welch Allyn, Inc., Skaneateles Falls NY, US |
| Decision | Substantially Equivalent, Mar 23, 2012 |
| Received | Mar 12, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120743
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2015 | Welch Allyn Inc Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers 78800, 73410, 73412, 73414, 73416, 78810, 78812, 78 Terminated |
HIB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.