510(k) K082828 ยท GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE
| Applicant | Suturtek Incorporated, Acton MA, US |
| Decision | Substantially Equivalent, Oct 14, 2008 |
| Received | Sep 25, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082828
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.