510(k) K921189 ยท LKX Device, Thermal, Hemorrhoids
THERMA-H
| Applicant | Zewa AG, Miami FL, US |
| Decision | Substantially Equivalent, Aug 31, 1992 |
| Received | Mar 3, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921189
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.