510(k) K142908 · FTL Mesh, Surgical, Polymeric
Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh
| Applicant | Sofradim Production, Trévoux, FR |
| Decision | Substantially Equivalent, Nov 14, 2014 |
| Received | Oct 6, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142908
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2018 | Covidien LLC Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20)
Product Usage:
The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional monofilament polyester Terminated |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.