510(k) K921738 ยท HIO Sampler, Amniotic Fluid (Amniocentesis Tray)
SONO-VU US(TM), MODIFICATION
| Applicant | E-Z-Em, Inc., Glens Falls NY, US |
| Decision | Substantially Equivalent, Apr 27, 1992 |
| Received | Jan 29, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921738
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.