510(k) K954095 ยท ILO Pack, Hot Or Cold, Water Circulating
MEDICOOL (MODIFICATON)
| Applicant | Microclimate Systems, Inc., Sanford MI, US |
| Decision | Substantially Equivalent for Some Indications, Mar 6, 1996 |
| Received | Aug 20, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954095
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.