510(k) K780818 ยท EFQ Gauze/Sponge, Internal
LAPAROTOMY SPONGE
| Applicant | Qualtex, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Jun 22, 1978 |
| Received | May 17, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K780818
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.