510(k) K170088 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film
| Applicant | Medela AG, Baar, CH |
| Decision | Substantially Equivalent, Apr 6, 2017 |
| Received | Jan 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170088
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2019 | Medela Inc Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224.
The Invia Foam Dressing Kit with FitPad consists of a foam pad, a section interface (Invia FitPad) and Transparent Film (one or m Terminated |
OMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.