510(k) K001287 ยท KPE Container, I.V.
EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
| Applicant | Sorenson Medical, Inc., West Jordan UT, US |
| Decision | Substantially Equivalent, Jun 9, 2000 |
| Received | Apr 24, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001287
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.