510(k) K830511 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
ZANLEX, ZAN-TEX & ZANDEX
| Applicant | Winn Hirsch & Assoc., Plainview NY, US |
| Decision | Substantially Equivalent, Mar 17, 1983 |
| Received | Feb 17, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830511
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.