510(k) K001328 ยท FEC Obturator, For Endoscope
INTRODUCER SHEATH
| Applicant | Novasys Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jul 17, 2000 |
| Received | Apr 26, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001328
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.