510(k) K812017 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
X-RAY DETECTABLE BAND
| Applicant | Isramed, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 20, 1981 |
| Received | Jul 17, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812017
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.