510(k) K002778 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
ENTERIC INJECTION CATHETER WITH IRRIGATION
| Applicant | Enteric Medical Technologies, Inc., Foster City CA, US |
| Decision | Substantially Equivalent, Nov 22, 2000 |
| Received | Sep 6, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002778
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.