510(k) K053254 ยท MPO Infant Heel Warmer (Chemical Heat Pack)
INFANT HEEL WARMER BY INTCO
| Applicant | Shanghai Intco Medical Supply Co., Ltd., Chino CA, US |
| Decision | Substantially Equivalent, Sep 19, 2006 |
| Received | Nov 21, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053254
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.