510(k) K080357 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
MEDELA INVIA WOUND THERAPY
| Applicant | Medela AG, Baar Zug, CH |
| Decision | Substantially Equivalent, Jul 24, 2008 |
| Received | Feb 11, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080357
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2011 | Medela Inc Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061.
Medela Healthcare,
McHenry, IL 60051;
A Wound Drain Kit containing a 10 mm Flat Drain, antimicrobial gauze pad, non-adherent wou Terminated |
MCY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.