510(k) K011484 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1
| Applicant | Olympus Optical Co., Ltd., Melville NY, US |
| Decision | Substantially Equivalent, Aug 10, 2001 |
| Received | May 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011484
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.