510(k) K123811 ยท NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
STITCHKIT
| Applicant | Origami Surgical, LLC, Dover MA, US |
| Decision | Substantially Equivalent, Sep 5, 2013 |
| Received | Dec 11, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123811
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.