510(k) K801365 ยท IME Pack, Hot Or Cold, Reusable
KOLD WRAP
| Applicant | Romaine, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Aug 7, 1980 |
| Received | Jun 10, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801365
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.