510(k) K841909 ยท HIB Speculum, Vaginal, Nonmetal
VAGINAL SPECULUM - DISPOSABLE
| Applicant | Galenica Enterprises, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Jul 31, 1984 |
| Received | May 9, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K841909
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2015 | CooperSurgical, Inc. McKesson Medi-Pak Vaginal Speculum, 10/bag
Reorder No. 11-8309
Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures Terminated |
HIB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.