510(k) K921963 ยท HIF Insufflator, Laparoscopic
DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900
| Applicant | Sun Medical, Inc., Arlington TX, US |
| Decision | Substantially Equivalent, Sep 11, 1992 |
| Received | Apr 27, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921963
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.