510(k) K983326 ยท HIF Insufflator, Laparoscopic
OMNIFLATOR 7640 MODEL 7-640-00
| Applicant | Northgate Technologies, Inc., Elgin IL, US |
| Decision | Substantially Equivalent, Feb 5, 1999 |
| Received | Sep 22, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983326
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.