510(k) K043383 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110
| Applicant | Physion, Inc., Short Hills NJ, US |
| Decision | Substantially Equivalent, Oct 27, 2005 |
| Received | Dec 9, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043383
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.