510(k) K983765 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
INJECTION NEEDLE PROBE/DEVICE-TUNIS
| Applicant | Ximed/Prosure/Injectx, San Jose CA, US |
| Decision | Substantially Equivalent, Dec 11, 1998 |
| Received | Oct 26, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983765
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.