510(k) K993582 ยท BTR Tube, Tracheal (W/Wo Connector)
MODIFICATION TO LASER-SHIELD II
| Applicant | Xomed, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Jan 20, 2000 |
| Received | Oct 22, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993582
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.