510(k) K063692 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000
| Applicant | Kci USA, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Jun 7, 2007 |
| Received | Dec 13, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063692
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2010 | KCI USA, Inc. AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #340225 used with Activac Model 340000, and ActiVAC (Canadian) Model 340013. Terminated |
OMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.