510(k) K913956 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30
| Applicant | Bentley Laboratories, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jan 17, 1992 |
| Received | Sep 5, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913956
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.