510(k) K981853 ยท FMI Needle, Hypodermic, Single Lumen
BONE INJECTION GUN (B.I.G.) DEVICE
| Applicant | Waismed, Ltd., Ginot Shomron 44853, IL |
| Decision | Substantially Equivalent, Nov 17, 1998 |
| Received | May 26, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981853
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.