510(k) K093112 ยท GAW Suture, Nonabsorbable, Synthetic, Polypropylene
DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE
| Applicant | Coloplast Manufacturing Us, LLC, Minneapolis MN, US |
| Decision | Substantially Equivalent, Feb 1, 2010 |
| Received | Oct 1, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093112
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.