510(k) K080985 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)
| Applicant | Surgical Specialties Corp, Herndon VA, US |
| Decision | Substantially Equivalent, Apr 23, 2008 |
| Received | Apr 7, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080985
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.