510(k) K922154 ยท HIB Speculum, Vaginal, Nonmetal
INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION
| Applicant | Olsen Electrosurgical, Inc., Concord CA, US |
| Decision | Substantially Equivalent, Apr 21, 1994 |
| Received | May 7, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922154
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.