510(k) K003323 ยท FTL Mesh, Surgical, Polymeric
COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
| Applicant | Davol, Inc., Cranston RI, US |
| Decision | Substantially Equivalent, Jan 22, 2001 |
| Received | Oct 24, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003323
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2007 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Hernia Patch-
Large Oval with ePTFE , 5.4'' x 7.0''
Product Number: 0010202 Completed |
FTL | None listed |
| Jan 30, 2007 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Hernia Patch-
Large Circle 4.5'' with ePTFE
Product Code: 0010204 Completed |
FTL | None listed |
| Feb 22, 2006 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Mesh X-Large Patch
Oval with ePTFE, 8.7'' x 10.7''
Code: 0010206 Completed |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.