510(k) K962983 ยท ILO Pack, Hot Or Cold, Water Circulating
STERILE SOFT-TEMP
| Applicant | Adroit Medical Systems, Inc., Loudon TN, US |
| Decision | Substantially Equivalent, Jan 10, 1997 |
| Received | Aug 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962983
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.