510(k) K081126 ยท FTL Mesh, Surgical, Polymeric
PARIETEX COMPOSITE MONO PM MESH
| Applicant | Sofradim Production, North Haven CT, US |
| Decision | Substantially Equivalent, Aug 13, 2008 |
| Received | Apr 21, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081126
| 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.