510(k) K911943 ยท ILO Pack, Hot Or Cold, Water Circulating
CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM
| Applicant | Burke, Inc., Largo FL, US |
| Decision | Substantially Equivalent, Jul 19, 1991 |
| Received | May 1, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911943
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.