510(k) K812554 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
TOMAC STERILE DISP. LAP SPONGE
| Applicant | American Convertors Div., American Pharmaseal, Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 24, 1981 |
| Received | Sep 8, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812554
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.