510(k) K003380 ยท HDX Dilator, Vaginal
BIOTEQUE VAGINAL DILATOR
| Applicant | Bioteque America, Inc., Langhorne PA, US |
| Decision | Substantially Equivalent, Jan 29, 2001 |
| Received | Oct 31, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003380
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.