510(k) K121522 ยท FRO Dressing, Wound, Drug
POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)
| Applicant | Polyremedy, Inc., Aliso Viejo CA, US |
| Decision | Substantially Equivalent, Jun 27, 2012 |
| Received | May 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121522
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.