510(k) K904583 ยท HIO Sampler, Amniotic Fluid (Amniocentesis Tray)
SONO-VU US(TM)
| Applicant | E-Z-Em, Inc., Worcester MA, US |
| Decision | Substantially Equivalent, Jun 24, 1991 |
| Received | Oct 9, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904583
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.