510(k) K083008 ยท ILO Pack, Hot Or Cold, Water Circulating
COOLSKIN
| Applicant | Elbio Co., Ltd., Roswell GA, US |
| Decision | Substantially Equivalent, Jun 10, 2009 |
| Received | Oct 8, 2008 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K083008
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.