510(k) K973590 ยท LKX Device, Thermal, Hemorrhoids
HEMORRELIEF DEVICE
| Applicant | A.Stein - Regulatory Affairs Consulting, Ginot Shomron 44853, IL |
| Decision | Substantially Equivalent, Feb 5, 1998 |
| Received | Sep 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973590
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.