510(k) K091366 ยท HIF Insufflator, Laparoscopic
INSUFLOW DEWHEART
| Applicant | Lexion Medical, LLC, St. Paul MN, US |
| Decision | Substantially Equivalent, Sep 3, 2009 |
| Received | May 8, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091366
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.