510(k) K063546 ยท HIF Insufflator, Laparoscopic
INSUFLOW DEVICE, MODEL 6198
| Applicant | Lexion Medical, LLC, St. Paul MN, US |
| Decision | Substantially Equivalent, Jan 10, 2007 |
| Received | Nov 24, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063546
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.