510(k) K895372 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
X-RAY DETECTABLE GAUZE SPONGE
| Applicant | Keilei Intl., Inc., Dover NJ, US |
| Decision | Substantially Equivalent, Nov 3, 1989 |
| Received | Aug 29, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895372
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.