510(k) K973447 ยท HIF Insufflator, Laparoscopic
OMNIFLATOR 6630(6-630-00)
| Applicant | Northgate Technologies, Inc., Elgin IL, US |
| Decision | Substantially Equivalent, Sep 30, 1998 |
| Received | Sep 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973447
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.