510(k) K111495 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
| Applicant | Wilson-Cook Medical, Inc., Winston-Salem NC, US |
| Decision | Substantially Equivalent, Jul 19, 2011 |
| Received | May 31, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111495
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.