510(k) K090217 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, Apr 23, 2009 |
| Received | Jan 29, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090217
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.