510(k) K082319 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
INJEKT FILIFORM INJECTION NEEDLE
| Applicant | Cook Urological, Inc., Spencer IN, US |
| Decision | Substantially Equivalent, Sep 25, 2008 |
| Received | Aug 13, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082319
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.