510(k) K091634 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
NMI FC
| Applicant | Navilyst Medical, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Mar 1, 2010 |
| Received | Jun 4, 2009 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K091634
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.