510(k) K103549 ยท MPO Infant Heel Warmer (Chemical Heat Pack)
DENOVO TEDDY GEL INFANT HEEL WARMER
| Applicant | Denovo Products, LLC, Fort Myers FL, US |
| Decision | Substantially Equivalent, Apr 8, 2011 |
| Received | Dec 3, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103549
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.