510(k) K953542 ยท IMD Pack, Hot Or Cold, Disposable
COLDGEL
| Applicant | Prism Technologies, Inc., Washington DC, US |
| Decision | Substantially Equivalent for Some Indications, Oct 30, 1995 |
| Received | Jul 28, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953542
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.