510(k) K082082 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
| Applicant | Gish Biomedical, Inc., Rancho Santa Margarita CA, US |
| Decision | Substantially Equivalent, Feb 4, 2009 |
| Received | Jul 23, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082082
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.