510(k) K901079 ยท BTO Tube, Tracheostomy (W/Wo Connector)
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER
| Applicant | L H M Ent., Inc., Palm Harbor FL, US |
| Decision | Substantially Equivalent, May 18, 1990 |
| Received | Mar 7, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901079
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.