510(k) K972383 ยท KLZ Tube, Shunt, Endolymphatic With Valve
EASY-JET DEVICE
| Applicant | A.Stein - Regulatory Affairs Consulting, Ginot Shomron 44853, IL |
| Decision | Substantially Equivalent, Nov 23, 1999 |
| Received | Jun 26, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972383
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.