510(k) K113644 ยท BSK Cuff, Tracheal Tube, Inflatable
PILOT TUBE REPAIR KIT
| Applicant | Instrumentation Industries, Inc., Bethel Park PA, US |
| Decision | Substantially Equivalent, Jan 26, 2012 |
| Received | Dec 12, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113644
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.