510(k) K100507 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
XRES BLOOD COLLECTION RESERVOIR
| Applicant | Sorin Group Italia S.R.L., Waltham MA, US |
| Decision | Substantially Equivalent, Mar 24, 2010 |
| Received | Feb 22, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100507
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.