510(k) K103568 ยท FTL Mesh, Surgical, Polymeric
RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, Dec 22, 2010 |
| Received | Dec 6, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103568
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 2, 2012 | Coloplast Manufacturing US, LLC Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460, Rx Only, Manufacturer, Coloplast A/S 3050 Denmark
Restorelle is a ploypropylene mesh that may be used for the Terminated |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.