510(k) K945543 ยท CAH Filter, Bacterial, Breathing-Circuit
GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE
| Applicant | Intersect Medical Products, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Nov 29, 1994 |
| Received | Nov 14, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945543
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.