510(k) K181369 ยท FMI Needle, Hypodermic, Single Lumen
Immucise Intradermal Injection System
| Applicant | Terumo Corporation, Shibuya-Ku, JP |
| Decision | Substantially Equivalent, Nov 13, 2018 |
| Received | May 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181369
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.