510(k) K112915 ยท BSK Cuff, Tracheal Tube, Inflatable
SPIRTIUS CUFF INFLATION SYRINGE
| Applicant | Spiritus Technologies, LLC, Lenexa KS, US |
| Decision | Substantially Equivalent, May 25, 2012 |
| Received | Oct 3, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112915
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.