510(k) K964354 ยท ILO Pack, Hot Or Cold, Water Circulating
ARTOCOOL-S WATER CIRCULATING COLD PACK
| Applicant | Ormed GmbH, Concord CA, US |
| Decision | Substantially Equivalent, Aug 29, 1997 |
| Received | Oct 31, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964354
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.