510(k) K020753 ยท KSR Container, Empty, For Collection & Processing Of Blood & Blood Components
DEROYAL SURGICAL, UMBILICUP
| Applicant | Deroyal, Powell TN, US |
| Decision | Substantially Equivalent, Jun 13, 2002 |
| Received | Mar 7, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020753
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2012 | DeRoyal Industries Inc DeRoyal (R) Umbilicup, REF 72-8000, Rx Only, STERILE EO, Manufactured by DeRoyal, Powell, TN 37849
Product Usage: Collection of cord blood Terminated |
KSR | None listed |
| Apr 12, 2012 | DeRoyal Industries Inc DeRoyal (R) Umbilicup, REF 72-8000NS, Rx Only, Manufactured by DeRoyal, Powell, TN 37849
Product Usage: Collection of cord blood Terminated |
KSR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.