510(k) K081313 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
SH14 HEMOCONCENTRATOR
| Applicant | Sorin Group Italia S.R.L., Waltham MA, US |
| Decision | Substantially Equivalent, Nov 19, 2008 |
| Received | May 9, 2008 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K081313
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.