510(k) K933521 ยท HIB Speculum, Vaginal, Nonmetal
SPECULUM
| Applicant | Bioteque America, Inc., Langhorne PA, US |
| Decision | Substantially Equivalent, Mar 7, 1994 |
| Received | Jul 20, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K933521
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.