510(k) K883984 ยท LKX Device, Thermal, Hemorrhoids
HEMORX COLD PACK
| Applicant | Bio-Dyne, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Dec 22, 1988 |
| Received | Sep 20, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883984
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.