510(k) K963595 ยท FMI Needle, Hypodermic, Single Lumen
SERAGARD VASCULAR ACCESS DEVICE
| Applicant | Cutting Edge Technologies, Inc., West Chester PA, US |
| Decision | Substantially Equivalent, Jan 6, 1997 |
| Received | Sep 9, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963595
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.