510(k) K181690 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
Clear-Jet Injection Catheter
| Applicant | Finemedix Co., Ltd., Daegu, KR |
| Decision | Substantially Equivalent, Dec 21, 2018 |
| Received | Jun 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181690
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.