510(k) K100823 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
WOUND PRO APEX
| Applicant | Accuro Medical Products, LLC, Denver CO, US |
| Decision | Substantially Equivalent, Jan 24, 2011 |
| Received | Mar 24, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100823
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2012 | Accuro Medical Product LLC Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wo Terminated |
OMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.