510(k) K070964 ยท HIB Speculum, Vaginal, Nonmetal
KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM
| Applicant | Welch Allyn, Inc., Skaneateles Falls NY, US |
| Decision | Substantially Equivalent, May 18, 2007 |
| Received | Apr 5, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070964
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.