510(k) K861645 ยท BTO Tube, Tracheostomy (W/Wo Connector)
MICRO-TRACHEOSTOMY CARE KIT
| Applicant | Aci Medical, Inc., Sunland CA, US |
| Decision | Substantially Equivalent, May 9, 1986 |
| Received | Apr 30, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861645
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.