510(k) K112547 ยท IMD Pack, Hot Or Cold, Disposable
NEO NEST
| Applicant | Denovo Proucts, LLC, Ft. Myers FL, US |
| Decision | Substantially Equivalent, Mar 6, 2012 |
| Received | Sep 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112547
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.