510(k) K113772 ยท FRO Dressing, Wound, Drug
HPR EMOLLIENT FOAM
| Applicant | Prugen IP Holdings, Inc., Scottsdale AZ, US |
| Decision | Substantially Equivalent, Feb 9, 2012 |
| Received | Dec 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113772
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.