510(k) K972654 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
MANIFOLD
| Applicant | Medical Specialties Intl., Inc., Tarpon Springs FL, US |
| Decision | Substantially Equivalent, Oct 8, 1997 |
| Received | Jul 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972654
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.