510(k) K093166 ยท FTL Mesh, Surgical, Polymeric
WITTMANN PATCH
| Applicant | Aperta, LLC, Casey Key Nokomis FL, US |
| Decision | Substantially Equivalent, Dec 7, 2009 |
| Received | Oct 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093166
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 27, 2012 | Novomedicus Llc The Artificial Bur Patch is a Temporary Fascial Prothesis. For Single Patient Use only. Use with Negative Pressure Wound Dressing.
Contents: Large Bur Patch (Sterile: EO), 20cm x 40cm Loop Sheet, 20cm Terminated |
FTL | None listed |
| Jan 27, 2012 | Novomedicus Llc The Artificial Bur HypoPack is a Temporary Fascial Prothesis with Hypobaric Wound Dressing. For Single Patient Use only.
Contents: 1. Large Bur Patch (Sterile: EO), 20cm x 40cm Loop Sheet, 20cm x 40cm Terminated |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.