510(k) K945866 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
CYLINDRICAL SPONGE
| Applicant | Lorrex Health Products, Secaucus NJ, US |
| Decision | Substantially Equivalent, Dec 28, 1994 |
| Received | Dec 1, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945866
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.