510(k) K121632 ยท FMI Needle, Hypodermic, Single Lumen
COMFORT EZ
| Applicant | Simple Diagnostics, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Aug 10, 2012 |
| Received | Jun 4, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121632
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.